Express Pharma (Vol.13, No.12) April 16-30, 2018

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CONTENTS Vol.13 No.12 April 16-30, 2018 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate

REINVENTING PHARMA TABLETTING

MARKET

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BIOSIMILARS SUMMIT INDIA 2018 TO BE HELD IN MUMBAI

MANAGEMENT

As tabletting undergoes a metamorphosis to tackle future opportunites and challenges, pharma experts review the progress in this field and discuss strategies for future growth | P16

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AGE-RELATED MACULAR DEGENERATION MARKET WILL ROCKET TO $11.5BN BY 2026

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ONGOING TRADE WAR WITH CHINA CAN HARM US BIOPHARMA INNOVATION: GLOBALDATA

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Dhaval Das (Web Developer) Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East

RESEARCH

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BERRY PIGMENTS CAN OPEN NEW AVENUES FOR CANCER TREATMENT

CIRCULATION Circulation Team Mohan Varadkar

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PRODUCTION General Manager BR Tipnis

Scheduling & Coordination Santosh Lokare

Automation solutions for PHARMA industry

LUPIN’S STEADY STRIDE ON BIOSIMS

Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry

Manager Bhadresh Valia

PHARMA ALLY

INDIA IS ONE OF IMA’S MOST IMPORTANT MARKETS FOR PHARMA PROCESSING EQUIPMENT

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‘IN HP-TLC, EACH AND EVERY PARAMETER THAT INFLUENCES THE RESULT IS CONTROLLED’

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EDITOR’S NOTE

Mozambique tightens pharma export process

F

rom March 15, Mozambique mandated pre shipment testing of pharma exports, choosing to start with India, which is its largest supplier of pharma products. Ravi Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) is all for the move. In fact, with Pharmexcil approaching more countries like Vietnam to move to this process, India’s pharma exporters should start planning in advance for similar mandates. He points out that the system is working very well in countries like Nigeria, as delays at the port of entry are avoided. This speeds up the export process, both for exporters as well as importing countries.

Some of India’s largest pharma companies, like Cipla, Glenmark and Ipca Laboratories to name just a few, are prominent exporters to Mozambique and other African countries. As per Ministry of Commerce data, pharma exports from India to Mozambique totalled ` 91.5 crore of total exports of ` 1000 crore, second to high speed diesel (` 757 crore). This includes retail sales of antibiotics and other medicines as well as tender-based sales of antimalarials.

The move has been in the works for some time now. Mozambique’s drug authority had flagged quality issues related to India-origin drugs in December 2016, around the time Vietnam’s drug regulator blacklisted 39 Indian pharma companies, who were allegedly exporting low-quality drugs.

The African nation’s regulators issued a Ministerial Decree dated March 6, 2017 introducing the preshipment inspection and testing programme. The pilot project was launched on January 18, with the Ministry appointing Mumbai-based Quntrol

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But no one is complaining

Laboratories as the independent inspection and testing company to carry out pre-shipment inspection and quality testing of all pharma export shipments out of India.

Besides giving a sense of assurance to all stakeholders, Riddhi Javeri, Director, Quntrol Laboratories, lists one more compelling benefit of this process. With the Clean Report of Inspection and Analysis (CRIA), the pharma manufacturer/exporter is assured that his shipment was as per required standards before it was shipped. This is important because if there is a problem with any part of his shipment after it reaches the importing country, the cause might lie with improper shipment or storage conditions as one of the reasons.

While pre shipment testing of pharma exports will involve some extra costs, like a one time nonrefundable registration fee of ` 20000 to register with Quntrol as an exporter, inspection fees per consignment, as well as some time lag, conforming to these quality standards can only burnish the credentials of individual pharma exporters as well as India Pharma Inc. With some advance planning, even smaller manufacturers/exporters will be able to cope with the initial hiccups.

In fact, pre shipment testing could end up saving money as non-compliant consignments will be held back before shipping costs are incurred. Similarly, there is no uncertainty of goods lying in warehouses in the destination country, awaiting test results, especially in smaller countries which lack the regulatory infrastructure to deliver test results in time. All in all, a win-win mandate for all concerned.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET PRE EVENTS

Biosimilars Summit India 2018 to be held in Mumbai An array of discussions will be held on market regulations, regulatory, funding etc

B

iosimilars Summit India 2018 will be held in Mumbai from May 10-11, 2018. Discussions will be held with industry experts on development, manufacturing to commercialisation - the current landscape, legal, regulatory, funding, challenges, market access strategy, business models and how to get to market.

Topics which will be discussed during the event are:

◗ Current Global Biosimilar Landscape & Policy Updates ◗ Opportunities – Business & Investment Models ◗ Bioanalytics and Interchangability ◗ Legal Considerations & Market Access and Commercialization ◗ Case Studies – From Development to Market ◗ Biosimilar Product Portfolios and Business Strategies ◗ Clinical Studies – Pharma-

CEOs, directors, VPs, department head, leaders specialising in biopharma will take part

ASIA LABEX 2018 to be held in Chennai More than 250 exhibitors from 15 countries, 3000 brands and eight seminar topics will be discussed during the event ASIA LABEX 2018, an international exhibition and conference on laboratory, analytical, biotech and diagnostic instruments and consumables will be held at Chennai Trade Centre (CTC), Chennai, Tamil Nadu, from April 19 – 21, 2018.

Asia Labex, the three-day focussed trade event, will give opportunity to laboratory manufacturers and laboratory suppliers to meet and do business with end users and decision makers from India’s leading industries, research laboratories and education sector. There will be 250+ exhibitors from 15 countries, 3000 brands and eight seminar topics in the expo and

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seminar.

The focus of show will be on the latest trends and technology in the area of analytical instruments, chromatography, spectroscopy and microscopy, microbiology, biotechnology and life sciences, laboratory chemicals, fine chemicals and reagent, lab consumables, laboratory glassware and plastic ware ,laboratory balances, molecular diagnostic, clinical diagnostic, haematology, haemostasis diagnostic reagents and equipment’s, laboratory analysers, serology, rapid test kits, laboratory automation, environmental lab instruments, nanotechnology, laboratory furniture, ma-

terial testing and measuring instruments, water treatment and filtration, process instruments and educational lab products.

Exhibiting companies besides presenting their innovations, products and services with key decision makers will be able to find the leads and confirmed orders. Attendees will have an unique opportunity to not only have the entire spectrum of the laboratory industry in one place, at one time, providing them total solution but an ideal platform to learn industry insights, connect with peers and grow professionally.

EP News Bureau

covigilance challenges ◗ Biosimilar Manufacturing and latest technologies Chief executives, directors ,vice presidents, department head, leaders and managers specialising in biopharmaceuticals/ biotherapeutics, legal affairs, intellectual property, health economics, pricing and reimbursement, research and development, formulation process control and analytical technologies, analytical charac-

terisation, principal scientist, chief scientific officer, pharmacovigilance, drug safety & risk management, regulatory compliance, quality affairs/ quality control, new product development, process science, portfolio management, research & development, business development, business operations, scientific affairs, commercial affairs, will take part in the summit.

EP News Bureau

7th Edition of PharmaTech Expo 2018 & LabTech Expo 2018 to be held in Chandigarh The focus will be on pharma manufacturing and processing technology, pharma systems and services THE 7TH Edition of PharmaTech Expo 2018 & LabTech Expo 2018 organised by PharmaTechnology Index.com, an International Exhibition on Pharma Machinery, Lab, Analytical, Pharma Formulations, Nutraceutical, Ayurvedic Formulations & Packaging Equipments will be held at Parade Ground, Sector 17, Chandigarh from April 27-29, 2018.

PharmaTech Expo 2018 & LabTech Expo 2018 is a premier event dedicated to pharmaceutical innovation, technology and knowledge. Showcasing the latest cutting-edge technologies needed to cost-effectively develop and manufacture quality products. This year the focus will be on pharma manufacturing and processing technology, pharma systems and services, pharma formulation, nutraceuticals, food and cosmeceuticals and ayurveda.

EP News Bureau

DEAL TRACKER

Pharma industry posts 57 deals worth $19 billion in March 2018 77 venture capital deals worth $2.1 billion were reported in March 2018 THE INDUSTRY reported 57 deals worth $19 billion in March 2018, compared to five months average of 63 deals worth $12.7 billion. GlaxoSmithKline’s (GSK) proposed acquisition of 36.5 per cent stake in consumer healthcare joint venture from Novartis for $13 billion has contributed nearly 68 per cent of the total deal value reported in the pharmaceutical and healthcare industry in March 2018.

The acquisition is expected

to be accretive to GSK’s adjusted earnings in 2018 and thereafter, is expected to strengthen operational cash flows. Together with its new launch opportunities and expected operational improvements, these financial benefits further support GSK’s increased confidence in its ability to deliver its 2020 outlook and invest effectively in the company’s other priorities.

Some of the other major transactions in March 2018 in-

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Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

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MARKET clude Platinum Equity’s proposed acquisition of LifeScan, a provider of consumer health products, from Johnson & Johnson for $2.1 billion; and Lundbeck’s proposed acquisition of Prexton Therapeutics, a company focussed on developing drugs to treat Parkinson's disease and other brain disorders, for $1.1 billion.

The pharma and healthcare industry reported 77 venture capital (VC) deals worth $2.1 bil-

Radiology Partners raised $234 M; Helix Opco $200 M and TCR2 Therapeutics $125 M

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

27-Mar-2018

GlaxoSmithKline Plc (UK)

Consumer Healthcare Joint Venture with Novartis

13,000.00

16-Mar-2018

Platinum Equity LLC (US)

LifeScan Inc (US)

2,100.00

16-Mar-2018

H. Lundbeck AS (Denmark)

Prexton Therapeutics BV (Netherlands)

1,117.20

29-Mar-2018

Fujifilm Corp (Japan)

Irvine Scientific Sales Company Inc; IS Japan Co., Ltd (Japan)

800.00

12-Mar-2018

Biogen Inc (US)

CIAS Asset (US)

590.00

lion in March 2018, as compared to five months average of 76 deals worth $1.4 billion. Some of the major deals in March 2018 include Radiology Partners raising $234 million in financing round; Helix Opco raising $200 million in Series B financing round; and TCR2 Therapeutics raising $125 million in Series B financing round.

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Deal Date

Acquirer (s)

Target Deal value

(US$ m)

09-Mar-2018

Future Fund; New Enterprise Associates Inc;

Radiology Partners, Inc. (US)

234.00

01-Mar-2018

DFJ Growth; Illumina Inc; Kleiner Perkins Caufield & Byers; Mayo Clinic; Sutter Hill Ventures LLC; Warburg Pincus LLC

Helix Opco LLC (US)

200.00

21-Mar-2018

6 Dimensions Capital; Alexandria Venture Investments; ArrowMark Partners; Cathay Fortune International Co. Ltd.; Curative Ventures; F2 Ventures Limited; Haitong International Securities Group Limited; Hillhouse Capital Group; Leerink Partners LLC; Lucion Venture Capital Group Ltd; Mirae Asset Financial Group; MPM Capital Inc; Redmile Group LLC; Sirona Capital; Syno Capital

TCR2 Therapeutics Inc (US)

125.00

26-Mar-2018

6 Dimensions Capital; Adrian Cheng; Ally Bridge Group; ARCH Venture Partners LP; AVICT Global Holdings Limited; Blue Pool Capital; Eight Roads Ventures; F-Prime Capital Partners; GIC Pvt Ltd; Harvest Investments; Mirae Asset Financial Group; Ping An Ventures; Venrock Healthcare Capital Partners LP; WuXi Venture Fund

Hua Medicine (Shanghai) Ltd (China)

117.40

01-Mar-2018

Flagship Pioneering Inc

Rubius Therapeutics Inc (US)

100.00

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April 16-30, 2018

MARKET EVENT BRIEFS DATA DECODE Date: April 26, 2018 Venue: Mumbai Summary: Pharma Data Analytics Summit will bring together industry leaders, technical experts, data scientist, innovators, and academia in data analytics to share their expertise, insights and experiences on key challenges, potential solutions and best practices in the industry. The conference will provide an interactive forum with thought leaders presenting latest developments, case studies, round table and panel discussion, interactive Q&A sessions to further develop and answer your queries and vibrant exhibition space with solution providers showcasing their technologies and software.

Contact details: Vik TyagiEmail: vik.tyagi@biotrains.com

701 - 702 Corporate House Nr Dinesh Hall, IncomeTax, Ashram Road, Ahmedabad - 380009 079 - 27540493

PHARMATECH EXPO 2018 & LABTECH EXPO 2018 Date: April 27-29, 2018 Venue: Parade Ground, Sector 17, Chandigarh Summary: PharmaTech Expo 2018 & LabTech Expo 2018 is an international exhibition on pharma machinery, lab, analytical, pharma formulations, nutraceutical and packaging equipment. Suppliers, manufacturers, industrialists, entrepreneurs, buyers and consultants will get the opportunity to assemble at this common platform.

Contact details

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IPHEX 2018 Date: May 8-10, 2018 Venue: Pragati Maidan Summary: iPHEX 2018 will bring together the drugs, pharmaceutical and healthcare industry – all under one roof. The event will be organised by Pharmexcil and supported by Ministry of Commerce and Industry, Department of Commerce, Government of India.

400 overseas buyers from focus areas are being invited to participate in

the exhibition.

Contact details Mumbai TV Industrial Estate, Unit No 211, 2nd Floor, 248-A, S K Ahire Marg, Worli, Mumbai – 400030 T: 91 22 24938750 F: 91 22 24938822

BIOSIMILARS SUMMIT INDIA 2018 Date: May 10-11, 2018 Venue: Mumbai Summary: Discussions will be held with industry experts on development, manufacturing to commercialisation – the current landscape, legal, regulatory, funding, challenges, market access strategy, business

models and how to get to market.

Topics which will be discussed during the event are: ◗ Current Global Biosimilar Landscape & Policy Updates ◗ Opportunities – Business & Investment Models ◗ Bioanalytics and Interchangability ◗ Legal Considerations & Market Access and Commercialization ◗ Case Studies – From Development to Market ◗ Biosimilar Product Portfolios and Business Strategies ◗ Clinical Studies – Pharmacovigilance challenges ◗ Biosimilar Manufacturing and latest technologies Contact details: Website: http://biosimilars. biotrains.com

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cover )

P

harma manufacturing has undergone a sea change in the past couple of decades.

Rapid advances in technology and production processes have led to companies’ augmenting their efficiencies and output, both quantitatively and qualitatively.

Enhanced maintenance and aftercare practices have also enabled

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pharma manufacturing facilities to attain an extended life and boost the benefits from their equipment and machinery.

Tabletting, one of the oldest and most widely used manufacturing techniques for solid dosage forms, has traversed a long journey.

Tablets are a preferred choice insolid dosage forms for their ability to provide patient compliance,

high-precision dosing, and manufacturing efficiency.

However, unprecedented shifts in drug discovery and the advent of next generation drugs which can also be administered through other dosage forms pose a threat to tabletting.

So, what are the measures needed for this field’s continued progress? How can tabletting rein-

vent itself to optimise its potential and eliminate its limitations? What is the way forward?

In an exclusive panel discussion, organised by Express Pharma, an eminent panel of pharma experts and veterans explored and examined answers to these queries.

We present important lessons learnt from the five experts on the panel:

(

THE MAIN FOCUS

By Lakshmipriya Nair

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cover )

When there is a difference between what is written and what is practiced, a big gap in GMP is exposed.

We should not only implement good designs and techniques but also adopt good practices in documentation.

The industry has graduated to automated, highspeed, rugged machines with high-compression forces and monitoring equipment. Yet, often basic things get overlooked and this causes glitches in the tableting process.

The punch and coating is very important for the development of a product.

Bisecting lines also have a lot of significance, they are not for just cosmetic purposes. It often determines the divisibility of the dosage.

As equipment become more sophisticated, it is possible to study and examine even minute aspects of the process.

Companies should engage in these studies to get tech transfer right

We need to investigate not only faulty batches but also our best ones to gain knowledge of combinations which work very well for future use and reference. A successful batch tells you how to replicate the success.

Sanjay Sharma

Ajit Kanetkar

Dr Vinay Nayak

Dr Sanjit Singh Lamba

Dr Girish Jain

Executive Director, Marksans Pharma

Managing Director, Eisai Pharmaceuticals, India

President, R&D, Alkem Laboratories

Head, Technology Transfer, Formulations (Sr General Manager), Lupin

Head-Process Technology & Training, ACG

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(

THE MAIN FOCUS

Begin with the basics: Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuticals, India Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuticals, India urges the industry to get the basic and simple details right as they are very crucial when it comes to achieving success.

He says, “The industry has graduated to automated, high-speed, rugged machines with high-compression forces and monitoring equipment.” Yet, often basic things get overlooked and this causes glitches in the tabletting process.

He provides a case in point by elaborating that while a lot of aspects are significant in tabletting, it all boils down to the quality of the punch. He states, “The quality of the punch and its infrastructure, both hardware and software are important.” Therefore, the success of the process also lies in how companies are studying and monitoring the functioning ability of the punches used.

Giving another example, he enlightens that even while machines have updated software and sophisticated features, small things like voltage fluctuation can cause a drop in productivity and quality. Therefore, companies should ensure that their machines are operating at optimal rates and maintain uninterrupted operations throughout the entire batch, especially as they expand their footprints and aims to compete with global players.

He stresses that despite automation, a lot of work and attention is needed in the back end to improve tabletting.

Dr Lamba also recounts instances of where Indian companies had all their products sent back within months of entering a new market because they didn’t meet the requirements, and emphasises that it is very important to get the processes right to get the perfect tablet, be it functionally or cosmetically. He points out that dissolution, compression, granulation, specifications, shine, etc. everything is important when it comes to tabletting.

He further informs that the Japanese market and other global markets come with very peculiar requirements, product-wise and in terms of regulations. Hence, his advice is that the players should carefully evaluate the availability, performance and quality of the tabletting equipment

to gain optimal results.

It is all in the details: Dr Girish Jain, President, Research and Development, Alkem Laboratories As a pharma scientist with decades of hands-on experience in tablet formulations, Dr Girish Jain, President, Research and Development, Alkem Laboratories emphasises on the need to pay attention to the smallest of details, when it comes to tabletting.

Dr Jain points out that the success of tabletting, a seemingly simple operation, is dependent on several formulation and process-related parameters.

For instance, he explained the importance of the punch and coating in the development of a product. He also pointed out the significance of bisecting lines and informed that they are not just for cosmetic purposes.

It often determines the divisibility of the dosage.

He called attention to the fact that throughput and efficiency can be hampered though several hitches in the tabletting process and hence even the smallest detail needs to be observed and evaluated thoroughly.

He explains that even small variations in formulations can have significant impact on tablets, be it on their solubility, compressibility or efficacy. He gave examples of bi-layer and tri-layer tablets to state his case.

Accentuating the importance of documenting each detail carefully, he says that it would be very beneficial for future reference and prove to be very crucial while applying for approvals in global markets. Dr Jain highlights the increasing stringency of global regulations and cites the approval process of the US FDA as an example.

He also recommends that a lot of controls need to be built into the processes, right from the R&D stage.

This measure would go a long way in improving accuracy and precision, eliminating dosage variations, boosting the ruggedness of the product and creating better efficacies.

Get it right the first time: Sanjay Sharma, Head, Technology Transfer, Formulations (Sr General Manager), Lupin Often companies in the pharma sector are faced with a scenario wherein a product has been developed

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cover ) and sent for manufacturing but they were forced to go back to R&D repeatedly because of some glitches.

Frequently, due to these delays, the competition gets a march ahead.

Sanjay Sharma, Head, Technology Transfer, Formulations (Sr General Manager), Lupin informs that these glitches occur due to issues in tech transfer, especially during scale-up in tabletting.

For instance, the speed difference of making a product in a relatively slower R&D press and on high-speed production machines is considerable. Until it is accounted for properly, there will be challenges in the tech transfer stage, leading to capping, cracks, chipping etc. in the tablets manufactured.

Sharma also opines that pharma companies often do not do proper justice towards studying the impact of their complete blend. However, he urges the companies to take up this practice as apart from mitigating tech-transfer challenges, it will also aid in appeasing US FDA which insists on whole time data to understand the physical and chemical attributes of the tablet.

Underscoring that lack of a proper tech transfer strategy results in wastage of productivity, time, money and resources, he also states that as companies seek to build a robust tableting system, it is pivotal to tackle challenges in tech transfer without losing the products' efficacy and equivalence.

He says that as equipment become more sophisticated, it is possible to study and examine even minute aspects of the process. He recommends that the companies should engage in these studies to get tech transfer right. He also urges scientists to rethink often implemented strategies to find better and simpler ways of product development. This will help in faster elimination of any anomalies in the product, thereby make tech transfer easier when it goes

20 EXPRESS PHARMA April 16-30, 2018

for manufacturing.

Befriend technology to accelerate progress: Ajit Kanetkar, HeadProcess Technology & Training, ACG As an expert with experience of working on both sides of the fence i.e. in pharma companies as well as with solution providers, Ajit Kanetkar, Head-Process Technology & Training, ACG, explains how technology is revolutionising tabletting. As automation touches every sphere of the process, he lays emphasis on choosing the right equipment when it comes to tabletting.

He says, “We see a lot of sophisticated machines but do not use all the features, especially in data compilation.

Probably it is the fear of tech-

nology. There are so many features available in these machines, for isntance, it is very easy to pull out data from the last few batches and examine its findings.“ Giving a rundown on the characteristics of different types of tablets, he informs about the features that tablet manufacturers should look for to gain the best results in each technique.

Bi-layered and multi-layered tablets: These three factors are very important ◗ Re-circulation so that lack of layer thickness, probability of contamination is reduced. ◗ The machine should be capable of individual weight check to maintain the optimal layer thickness and ensure that it is not lost during the processes.

◗ Pre-compression is also important, compression forces on machine and granule characteristics is a result of the machine as well.

Mouth dissolving tablets: They have low-hardness and are high on friability. So the equipment should have excellent ejection.

OROS tablets: Choose an equipment which will prevent any surface damage to tablets as they get thrown in the air.

It should also help achieve the right release profile.

MUPS: Two important things to be kept in mind while choosing a machine for these products are segregation and pre-corporation. Choose a single rotary and the feeder's RPM should be less than the machine's RPM to prevent segregation and crushing of

beads.

Another insight from him was that we need to investigate not only faulty batches but also our best ones to gain knowledge of combinations which work very well for future use and reference.

He said that a batch which is not working properly only tells you what is wrong but a successful batch tells you how to replicate success.

Knowledge sharing is vital: Dr Vinay Nayak, Executive Director, Marksans Pharma Dr Vinay Nayak, Executive Director, Marksans Pharma explains that tabletting has changed to incorporate several types of innovative tablets and recommends that innovation should be made a

( part of the whole process to stay at par with changing times.

He also emphasises on the very crucial need to peruse and document data whenever any tabletting technique is applied. Scanty data in the filings will adversely affect inspections. He said, “When there is a difference between what is written and what is practiced, a big gap in GMP is exposed. We should not only implement good designs and techniques but also adopt good practices in documentation.”

Dr Nayak explains that this would help in alleviating complex problems as data will enable the industry to predict potential issues and take proactive steps towards mitigating them. For instance, designing APIs with appropriate properties can help improve the tabletting process He affirms that the data can be also used to devise more effective and suitable tabletting machine settings.

The learnings can also be shared so that the whole pharma community benefits and grows.

Dr Nayak also lauds Express Pharma for being a facilitator of such knowledge sharing platforms.

The way forward The industry is adopting improved tabletting practices such as high-production rates and continuous production processes.

Every aspect of tabletting, be it the formula, excipients, production process or documentation, is getting automated with an aim to improve reproducibility, precision, and consistency in tabletting science. Adoption of the concept, ‘Quality by design’, is contributing significantly to the quality, safety and efficacy of drug products created through this process.

These advancements and patents in tablet technology have led to the creation of several modified release tablet

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formulations which are suited to current demands, including in-lay tablet, bi-layered tablet, medicated chewing gum, tablet tarts, pastilles, lollipop, tablet inserts, clinicaps,

caplets, child ecstasy tablet and tablet in tablet etc.

However, as the pharma manufacturing industry undergoes a metamorphosis driven by market demands,

THE MAIN FOCUS

tabletting will also have to continue anticipating the changes which would come its way and create capabilities to deal with the opportunities as well as challenges. Like any

other scientific field, it will have to evolve to be more agile and responsive in a bid to stay relevant. lakshmipriya.nair@expressindia.com

MANAGEMENT

Age-related macular degeneration market will rocket to $11.5bn by 2026 The growth will be driven by new therapies entering the market and a global aging society, which will lead to increasing numbers of elderly people developing AMD

P

harmaceutical sales within the age-related macular degeneration (AMD) markets were estimated to be $4.9bn across the seven major markets (7MM) in 2016. This is expected to reach $11.5 bn in 2026, at an impressive Compound Annual Growth Rate (CAGR) of 8.9 per cent, according to GlobalData, a leading data and analytics company.

The company’s report: ‘PharmaPoint: Age-Related Macular Degeneration’ states that this growth will be driven by new therapies entering the market and a global aging society, which will lead to increasing numbers of elderly people developing AMD. GlobalData predicts the launches of three drugs for the treatment of geographic atrophy (GA), the late stage of dry age-related macular degeneration (dAMD), and three latestage pipeline drugs for wet AMD (wAMD). In particular, the launch of drugs into the AMD market to treat dAMD will be a large driver of growth, as there are currently no prescription medications available for these patients.

Edit Kovalcsik, Healthcare Analyst, GlobalData, com-

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MANAGEMENT ments, “We expect that with the launch of brolucizumab in the wAMD market, Novartis will offset the losses to Eylea and regain dominance in the AMD market. Once more efficacy and safety data accumulates and physicians become more accustomed to the use of brolucizumab, its advantage of

sised that pricing will also play a key role in the uptake of brolucizumab. Novartis’ brolucizumab is expected to reach blockbuster status by 2021, and will be the highest selling drug by 2026 among all drugs launching to the AMD market, with $4.1bn in global sales.

New drugs entering the

New drugs entering the dAMD market will include two anticomplement agents: Apellis’ APL-2 and Ophthotech’s Zimura, and one neuroprotective agent, Allergan’s Brimo DDS, which together will drive an increase of the treated AMD cases, expanding the AMD market less frequent dosing will allow it to claim an increasing share and become a first-line therapy if reimbursed.”

Key opinion leaders interviewed by GlobalData empha-

dAMD market will include two anti-complement agents: Apellis’ APL-2 and Ophthotech’s Zimura, and one neuroprotective agent, Allergan’s Brimo DDS, which to-

gether will drive an increase of the treated AMD cases, expanding the AMD market.

Kovalcsik adds, “Following the failure of both Phase III trials of lampalizumab for the

treatment of GA, Apellis’ APL2 emerged as the most promising GA drug after its positive Phase IIa results were announced. Provided that the planned Phase III trial of APL-

2 for GA will confirm these results, we forecast that Apellis’ drug will reach blockbuster status within a few years of its launch, by 2025.”

EP News Bureau

Ongoing trade war with China can harm US biopharma innovation: GlobalData China currently appears to be in a much better position from a negotiation standpoint, as the Chinese biopharma industry does not seem to be threatened by this move WHILE THE ongoing trade war between the US and China will have huge ramifications on the biopharmaceutical industry for both countries. However, it appears that China is in a much better position from a negotiation standpoint, according to leading data and analytics company GlobalData.

On April 3, 2018, the US Trade Representative’s (USTR) office announced its intention to add a 25 per cent tariff on around $50 billion worth of Chinese imports across 1,300 product categories, many of which are used

24 EXPRESS PHARMA April 16-30, 2018

by drug makers. According to the Food and Drug Administration (FDA), approximately 80 per cent of active pharmaceutical ingredients (APIs) used by US manufacturers come directly from China and India.

The Trump administration has continuously mentioned reducing drug prices in order to drive patient costs down, but the proposed tariff is expected to do just the opposite.

Ashwin Oberoi, Mchem, Oncology Analyst, GlobalData, says: “This could be concerning for US generics drug makers such as Novartis’ Sandoz,

Pfizer, Teva and Mylan, and potentially even companies that produce biosimilars, as the proposed tariff could increase manufacturing costs and result in higher prescription drug costs for patients across the US.” China responded by imposing a 25 per cent duty on 106 US goods, but decided not to add such tariffs for US drugs being imported into China. In addition, the Chinese government offered a preferential tax rate of 15 per cent to generic drug makers in the hope to help reduce medical bills for patients and foster innovation.

Following China’s actions, President Trump instructed the USTR on April 5, 2018 to consider adding an additional $100 billion worth of tariffs on Chinese imports. The US government will place a 25 per cent tariff on raw drug ingredients, insulin, epinephrine and vaccines.

According to GlobalData, China currently appears to be in a much better position from a negotiation standpoint, as the Chinese biopharma industry does not seem to be threatened by this move.

Oberoi concludes, “The uncertainty of these new pro-

posed tariffs may diffuse through the entire value chain of the biopharma industry and negatively affect US patients, payers, and generics and biosimilar drug makers. It may lead to reduced trade with China as the US biopharma companies may opt for procuring APIs from other countries such as India.

“In a scenario where prices are capped, there may be less investment going into R&D, which could potentially harm US innovation in the longer term.”

EP News Bureau

RESEARCH

Lupin’s steady stride on biosims Lupin’s biosimilar plans are reaching a crucial inflexion point, with recent positive global Phase III results of its etanercept biosimilar for rheumatoid arthritis. As research on other biosimilars in its pipeline picks up pace, Lupin is now a serious contender in this space

By Viveka Roychowdhury

T

his February, Lupin moved a crucial step closer to the launch of its first biosimilar for the global market, when its joint venture, YL Biologics (YLB) announced positive outcomes of a global Phase III clinical trial of its etanercept biosimilar (YLB113).

Speaking at the launch, Dr Cyrus Karkaria, President, Lupin's biotech division, indicated that the company would be be filing for regulatory approval for YLB 13 in Q1FY19 in Japan and the EU, while India would follow in Q1FY19 or Q2FY19.

YLB is a JV between Lupin and Japan’s Yoshindo, formed in April 2014, and etanercept biosimilar, developed by Lupin’s Pune-based Biotechnology Research Group, was the first product to be licensed for clinical development to YLB. YLB113’s efficacy and safety was compared against Enbrel (of Amgen/Pfizer) which has a global market of $11 billion (IQVIA MAT Q3 2017). Etanercept is used to treat rheumatoid arthritis (RA) and other autoimmune disorders.

The Phase III study of YLB113 was a multinational randomised double-blind controlled trial of 52 weeks duration which included more than 500 patients with RA in 11 countries. More than half of the patients (260) were Japanese, recruited from 62 rheumatology clinics in that country, which according to company officials, is quite unusual for a global RA trial in Japan. The remaining 48 rheumatology clinics were from Europe and India.

According Dr Dhananjay Bakhle, Executive VP, Medical Research, Lupin, the primary

26 EXPRESS PHARMA April 16-30, 2018

Lupin Biotech Park, Pune

endpoint was an equivalent improvement in RA, as measured

by American College of Rheumatology 20 (ACR20) response rate. The ACR20 response rate of YLB113 was found to be within a pre-defined equivalence margin that is expected by most advanced regulatory agencies for marketing authorisation. In addition, safety and immunogenicity (antibody formation) of YLB113 was also found to be similar to Enbrel indicating therapeutic equivalence.

Given the number of patients from Japan, company representatives seemed confident that the Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA) would approve the biosimilar. If the filing is completed as targeted in FY2019, estimating a year for regulatory review by PMDA, Lupin is looking at a launch in Japan in FY2020 or later.

Enbrel’s patent expired in 2012 but continues to November 2028 in the US, after the

originator Amgen was granted a new patent. According to a presentation by Vinita Gupta, CEO, Lupin, at the JP Morgan Healthcare Conference (JPMHC) this January, the company targets to file in the US by Q3FY20.

The JPMHC presentation also details Lupin’s strategy as the only Indian player and the sixth largest generic pharma player in Japan. It is evident that biosimilars is a key part of its strategy to have a hybrid portfolio, evolving from its current focus on mature brands to complex generics, to biosimilars and finally to speciality business.

Complex research The positive late trial results on etanercept are a significant achievement as R&D related to developing the biosimilar had many complexities, points out Karkaria. Etanercept is a biopharma compound whose mode of action in the treatment of autoimmune diseases is to interfere with the tumour necrosis

factor (TNF, a soluble inflammatory cytokine) by acting as a TNF inhibitor.

The Lupin-YLB clone consists of an extracellular ligandbinding portion of the human (p75) TNF receptor, linked to the Fc portion of a human immunoglobin (IgG1) antibody. The mechanism of action involves competitive inhibition of soluble TNF-alpha binding to its receptor. According to Bakhle, despite the complexity of engineering of this molecule, biosimilarity to Enbrel was established by totality of evidence starting from analytical similarity, pre-clinical study comparisons, Phase I studies in India and Japan and finally through a global phase III study. As he puts it, “Ultimate proof of the pudding is in the eating,” hence phase III in a large number of patients suffering from moderate to severe RA was the platform for comparing therapeutic equivalence of Lupin’s product.

Development challenges of

the Lupin-YLB clone included 21 changes in the manufacturing process of the reference drug.

The upstream process involved choosing a clone with high productivity, controlling post-translational modification and refolding, scale up associated changes, and controls related to raw material, process, impurities and costs. Downstream challenges included those related to virus inactivation and clearance, impurity clearance, yield clearance and consistency, process controls and inprocess stability. Formulation of the trial product presented challenges like accurate composition, aseptic manufacturing, stability, device function and cold storage and shipping.

Challenges on the clinical side included PK/PD, bioequivalence, immunogenicity, and injection site reactions.

Finally, the regulatory challenges pertained to the choice of reference product and the differences in the regulatory requirements across different

The small molecule patent cliff is passe. Now companies are tracking the biologics patent cliff. The difficulty level of replication is much higher (in biologic) than with small molecules

Dr Cyrus Karkaria President Biotechnology, Lupin

agencies like the US FDA, EMA, PMDA, DCG(I). For example, various regulatory authorities may judge the criteria for therapeutic equivalence slightly differently as it happened in the case of etanercept. While EMA and PMDA accepted an equivalence margin as 15 per cent, US FDA wanted a tighter margin of 12 per cent. The clinical trial results were then analysed differently according to such criteria and Lupin’s product passed the more stringent criteria of US FDA as well. “The world of clinical research as judged by advanced regulatory agencies is much tougher to meet for complex products such as etanercept and Lupin’s level of expertise got fully tested and validated in the process,” explains Bakhle.

Biosimilar play As the fifth largest company in India’s pharma market (IQVIA MAT December 2017), and the seventh largest generic company globally, Lupin’s biotech play started a decade back with the establishment of the Pune facility in 2008. Today Lupin’s biotech facility is spread over 22,000 square metres, with a talent pool of close to 300 people, consisting of approximately 11 per cent PhDs and 63 per cent post-graduates. Its first two oncology products, Lupifil and Lupifil-P (biosimilars for Filgrastim and Peg-Filgrastim molecules respectively) were commercialised in India in 2015, marking Lupin Biotech's first step on the evolution curve.

Besides etanercept , another product in the pipeline, ranibizumab has the potential to be in the first wave of entrants across major markets. Additionally, Lupin has novel molecules in various stages of development across diverse indications such as oncology and endocrine disorders.

The establishment of biosimilars in regulated and semi-regulated markets by 2020 will be the second step in its mission to evolve up the biotech value chain. The February announcement of YLB113’s positive results make this target fairly doable. By 2025, Lupin Biotech aims to gain first mover advantage with new generation biosimilars and graduate to novel biological entities (NBEs).

Lupin’s strategy is to choose products that are difficult to make, have an entry barrier and therefore a larger competitive interest in the long run. Though Lupin might be one of the last to join the biologics bandwagon, they do get results, no doubt learning from the missteps of other peers. But will the delay cost them in terms of market share?

February’s announcement came after five and a half years of development, during which two Indian companies, Cipla and Intas Pharma, launched their biosimilars of etanercept. While Cipla launched in April 2013, at a price that was reportedly 30 per cent lower than that of Amgen’s product, Intas Pharma followed two years later, in

To subscribe: bpd.subscription@expressindia.com

more players launch their etanercept biosims, Lupin will have a cost advantage as it is made in India. “The small molecule patent cliff is passe. Now companies are tracking the biologics patent cliff.” Though there are five-six biologics losing patent protection in the next few years, he says the difficulty level of replication is much higher than with small molecules. As is oft repeated, with biologics, the process is the product, and even small changes in the process can change the properties of the biosimilar. Doctors thus take longer to be convinced of the safety of biosimilars versus the original molecules. Hence the

as well.

Giving examples, he says, “The number of patients required for a global phase III study were upwards of 500 for Lupin, whereas Schedule Y requirement is around 100 patients. The rigour of doing a global phase III study with half the patients coming from Japan and rest from Europe is a different ballgame for an Indian MNC. The way CMC data is scrutinised by PMDA, EMA and FDA is much more rigorous and challenging for a biosimilar being developed for these advanced markets. Sustaining competition in the global market requires inherent strengths of the product

Ultimate proof of the pudding is in the eating hence phase III in a large number of patients suffering from moderate to severe RAwas the platform for comparing therapeutic equivalence of Lupin’s product Dr Dhananjay Bakhle Executive VP, Medical Research, Lupin

March 2015.

Explaining how Lupin’s biosimilar strategy differs from other peers in India and the delay in launch, Karkaria says, “When a pharma company develops (a biosimilar) with the India market, the (development) time is less but it has problems in the global market. So Lupin targetted Japan, EU and then India. Studies done in the RoW markets won't hold in these markets. This is a big advantage of starting late, because you learn from other people’s mistakes.

We didn't jump the gun, instead negotiated with each global authority.” He indicated that they are ''doing the spade work'' looking for partners for the US market, but the US launch is still some way off, as there are IP issues as well.

Karkaria indicates that while there will be price erosion, as

switch to biosimilars is slower than with generics.

Next steps The biosimilars road ahead is not without its challenges. Besides global competition from the likes of Novartis which is fighting a patent challenge from Amgen for the etanercept US market, Lupin’s biosimilar will be launch quite some time after its peers in the India market.

But company leaders seem confident of making a strong mark when they do launch.

Bakhle points out that both the competitor products have been developed for the Indian market, whereas Lupin’s etanercept has been developed for global markets which puts enormous responsibility on the company to demonstrate totality of evidence from laboratory stage to clinic passing through animal studies

and the clinical research designs and implementation to pass through the technical entry barriers that are tougher than market barriers.”

On the price front like Karkaria, he too refrains from disclosing specifics commenting, “We’ll certainly be competitive but would not like to reveal our market strategy at this stage.”

One of the next steps is to compare Lupin’s mode of delivery with etanercept autoinjectors and demonstrate differences if any. Bakhle reveals that their study is in 150 patients of RA and yet to begin though they have received regulatory approvals. All in all, Lupin’s moves on the biosimilars front, may have been slow but are worth watching more closely in the days ahead. It could be the tortoise that finally wins the race. viveka.r@expressindia.com

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RESEARCH UPDATES

Berry pigments can open new avenues for cancer treatment The pigments can regulate a key enzyme in cancer cells NATURALLY OCCURRING pigments in berries, also known as anthocyanins, increase the function of the sirtuin 6 enzyme in cancer cells, a newstudy from the University of Eastern Finland shows. The regulation of this enzyme could open up new avenues for cancer treatment. The findings were published in Scientific Reports.

Sirtuins are enzymes regulating the expression of genes that control the function of cells through key cellular signalling pathways. Ageing causes changes in sirtuin function, and these changes contribute to the development of various diseases. Sirtuin 6, or SIRT6 for short, is a less wellknown enzyme that is also linked to glucose metabolism.

Berries get their red, blue or purple colour from natural pigments, anthocyanins.“The

most interesting results of our study relate to cyanidin, which is an anthocyanin found abundantly in wild bilberry, blackcurrant and lingonberry,” says Minna Rahnasto-Rilla, Doctor of Pharmacy, the lead author of the article.

Cyanidin increased SIRT6

enzyme levels in human colorectal cancer cells, and it was also discovered to decrease the expression of the Twist1 and GLUT1 cancer genes, while increasing the expression of the tumour suppressor FoXO3 gene in cells.

The researchers also de-

signed a computer-based model that allowed them to predict how different flavonoid compounds in plants can regulate the SIRT6 enzyme.

The findings indicate that anthocyanins increase the activation of SIRT6, which may play a role in cancer pathogene-

sis. The study also lays a foundation for the development of new drugs that regulate SIRT6 function.

Working at the School of Pharmacy of the University of Eastern Finland, the Sirtuin Research Group studies whether anthocyanins found in berries could activate SIRT6 function and, consequently, reduce the expression of cancer genes and cancer cell growth. The group also develops new compounds targeting the epigenetic regulation of gene function.

The Finnish-American study included researchers from the University of Eastern Finland and the National Institute on Ageing in the US. The study was funded by the Academy of Finland, the Finnish Cultural Foundation, and the US National Institute of Health.

EP News Bureau

Lesaffre Human Care launches scientific papers on women’s health Promising anti-fungal and anti-inflammatory properties for vaginal candidiasis therapy LESAFFRE HUMAN Care, supplier of quality ingredients from yeast and bacteria fermentation for the global human care markets, has announced the recent publication of two new scientific papers1,2 reiterating the beneficial effects of S. cerevisiaebased ingredients in preventing vaginal infections and helping women manage their

28 EXPRESS PHARMA April 16-30, 2018

day-to-day intimate health: in the Medical Journal of Obstetrics and Gynecology and in Beneficial Microbes.

The two publications mentioned above show continuous recognition from the scientific community of the company’s long-term investment in providing strong scientific and clinical data to substantiate the unique health benefits of

its ingredients. For example, research supporting the positive effects of the company’s exclusive S. cerevisiae-based ingredients in women health has been published in several peer-reviewed journals3,4 and presented at industry-events and international conferences on numerous occasions since 2016. However, Lesaffre Human Care continues to

investigate and deepen its understanding and expertise to provide unmatched data to support their efficacy.

“As an ingredient supplier, we believe that obtaining such scientific validation is paramount; which is why we are committed to standing out among ingredients suppliers by delivering second to none expert information to our

customers and acting an industry-leader in this regard.

We pledge to always provide safe ingredients vetted by the scientific community and that offer unique benefits backed by extensive research. In doing so, we seek to bring extra value to the health & nutrition industry while building trust and lasting relationships with our partners,” explains

RESEARCH Véronique Lhommet, Women’s Health Product Manager at Lesaffre Human Care.

To further their knowledge of S. cerevisiae CNCM I-3856 benefits on women’s intimate health, the company launched a clinical study. The goal was to research the effects of oral administration of this probiotic 5 yeast as an adjuvant therapy in women suffering from vulvovaginal candidiasis (VVC). Results, which spearheaded the publication in the Medical Journal of Obstetrics and Gynecology1 of one of the new scientific papers, showed that probiotic yeast S. cerevisiae CNCM I-3856 is “easyto-use and well tolerated” and that “the probiotic yeast is efficient in controlling vaginal Candida proliferation after conventional treatment thus limiting VVC recurrence.”

“Writers also called our exclusive S. cerevisiae-based probiotic a “natural breakthrough for vaginal health”1 which is invaluable for over 75 per cent of women around the world who experience at least one episode of vaginal infection in their life, many of whom suffering from recurrence,” explains Véronique Lhommet.

In addition to these findings, the peer-reviewed paper published in Beneficial Microbes2 this February revealed promising anti-fungal and anti-inflammatory properties for vaginal candidiasis therapy. Researchers concluded that “the beneficial effect exerted by this S. cerevisiaebased probiotic is the result of its interference with the expression of fungus virulence factors coupled with the modulation of the inflammatory response of the host.”

All of these new discoveries strengthen previous research results on Lesaffre Human Care’s S.cerevisiae-based ingredients for women health enhancement and prompt the company to keep investing in clinical research to reveal the full potential of each and every one of its health-promoting ingredients.

References 1 Cayzeele-Decherf A, Pélerin F,

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Jüsten P (2017) Saccharomyces cerevisiae CNCM I-3856 as a Natural Breakthrough for Vaginal Health: A Clinical Study.

Med J Obstet Gynecol 5(4): 1112. https://www.jscimedcentral.com /Obstetrics/obstetrics-5- 1112.pdf 2 E. Gabrielli, E. Pericolini, N. Ballet, E. Roselletti, S. Sabbatini, P. Mosci, A. Cayzeele Decherf, F. Pélerin, S. Perito,

P. Jüsten & A. Vecchiarelli (2018) Saccharomyces cerevisiae-based probiotic as novel anti-fungal and anti-inflammatory agent for therapy of vaginal candidiasis. Beneficial Microbes 2018 9(2): 219-230. http://www.wageningenacademic.com/doi/pdf/10.3920/BM201 7.0099 3 Wilson D, A tale of two yeasts:

Saccharomyces cerevisiae as a therapeutic against candidiasis.

2016, Virulence 31:1-3.

4 Pericolini E, Gabriellini E, Ballet N, Sabbatini S, Roselletti E, Cayzeele Decherf A, Pélerin F, Luciano E, Perito S, Jüsten P & Vecchiarelli A. Therapeutic activity of Saccharomyces cerevisiae-based probiotic and inactivated whole

yeast on vaginal candidiasis.

2016, Virulence 19:1-17.

5 The World Health Organization defines probiotics as "live micro-organisms which, when administered in adequate amounts, confer a health bene?t on the host." EP News Bureau

PHARMA ALLY I N T E R V I E W

India is one of IMA’s most important markets for pharma processing equipment Michele Arduini, Sales & Marketing Director, IMA Life and Luca Cavazzini, Sales & Marketing Director, IMA Active,talk about the recently held IMA India Pharma Process event, its new sales unit in Mumbai and the company's products pipeline, in an interaction with Swati Rana

Brief us about IMA India Pharma Process. What was the theme of the event?

Michele Arduini (MA): India is undoubtedly one of IMA's most important markets as far as pharma processing equipment is concerned, as evidenced by the remarkable successes achieved in recent years.

This led us to set up a new sales unit in India dedicated to the sales and service of solid dose (IMA Active division) and aseptic processing and freeze drying solutions (IMA Life division).

The headquarters of IMA India Pharma Process are located within the existing IMA-PG India facility in Mumbai, which has been taking care of the sales and service of IMA’s pharma packaging equipment (IMA Safe division).

We are sure that our new unit, with its sales, engineering and service teams (the latter counting 10 fully trained service engineers, but numbers are progressively increasing), will enter the pharma process market in India providing an even more structured approach with the highest levels of service and professionalism.

The event was hosted on March 20-21, 2018, by IMA

30 EXPRESS PHARMA April 16-30, 2018

Our new unit, with its sales, engineering and service teams, will enter the pharma process market in India providing a more structured approach with highest levels of service and professionalism Michele Arduini Sales & Marketing Director, IMA Life

IMA’s leadership position is the result of significant investment in R&D, regular and constructive dialogue with end users in its sectors and the Group’s ability to expand internationally, conquering new markets Luca Cavazzini Sales & Marketing Director, IMA Active

Life and IMA Active in Mumbai. The event was held to introduce the new sales team in India to focus on the sales and service of solid dose, aseptic processing, filling technology and freeze drying solutions. After a presentation of the new sales branch, whose headquarters are located within the IMAPG India facility in Mumbai, delegates were invited to attend two dedicated technology sessions where speakers from IMA Life and IMA Active presented new technological developments, innovative solutions and manufacturing strategies.

On the second day, the audience experienced live demos at the IMA-PG plant focussed on IMA Active’s Prexima and Sensum machines. The two-day event was a valuable opportunity to introduce our new office with its sales, engineering and enhanced service teams to our customers, providing innovative ideas for open forum discussions and networking opportunities on current trends in the Indian pharma industry.

Tell us about the sessions which took place and how did it benefit the industry?

MA: The inauguration ceremony offered us a perfect opportunity to introduce how IMA Life can create value to our customers through the technology, process knowledge and service support. Technical presentations focussed on sophisticated aseptic filling techniques for liquid and powder products, decontamination cycle technologies in isolated filling lines and advanced solutions in freeze drying in-process monitoring and control practices. Special attention was dedicated to Quantum, our new noninvasive technique capable of performing quantitative, real-time process measurements applied to freeze drying and to continuous freeze drying

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For more than 50 years, IMA Group is a world leader in the design and manufacture of automatic machines for processing and packaging of pharma products

improved process.

Luca Cavazzini (LC): The grand opening event was a great opportunity for a brief introduction to IMA Active machine portfolio for each solid dose processing phase: granulation, tabletting, capsule filling, weight

PHARMACEUTICAL

S ol uti o ns

Lubrizol LifeSciences is your pharmaceutical solution partner.

We provide support from idea to execution.

How we do it: • Polymers: high performance pharmaceutical ingredients for applications including sustained release oral solids, semisolid and liquid, transdermal applications and drug eluting devices • Formulation: advanced drug delivery solutions, including drug-eluting devices • Manufacturing: contract manufacturing for complex pharmaceutical drug delivery systems To learn more, visit www.lubrizol.com/lifesciences or email LifeSciencesIndia@lubrizol.com

© 2017 The Lubrizol Corporation, all rights reserved.

All marks are the property of The Lubrizol Corporation.

The Lubrizol Corporation is a Berkshire Hathaway company. 17-80600 Lubrizol Advanced Materials India Pv.t Ltd., 5th, 6th & 7th Floor, Jaswant Landmark, LBS Marg, Vikhroli (W), Mumbai- 400079, India Ph.: +91 22 6607800 Email id : LifeSciencesIndia@lubrizol.com

PHARMA ALLY checking, coating, handling and washing. All IMA Active solutions benefit from in-depth experience and cutting-edge technologies, taking advantage of the know-how belonging to experts specialised in individual product lines.

They are also capable of sharing this knowledge within a team. A special insight on APV Expert Workshop Tableting showed the results of the practical demonstrations: Prexima performed the best stability of tablets weight in production conditions and with different formulations.

How do you see the process and packaging market in Indian pharma industry?

MA: Indian pharma sector is estimated to account for 3.1 – 3.6 per cent (as of 2016) of the global pharma industry in value terms and 10 per cent in volume terms. It is expected to grow to $100 billion by 2025. The country’s pharma industry is expected to expand at a CAGR of 12.89 per cent over 2015–20 to reach $ 55 billion. India is the

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PHARMA ALLY second largest contributor of global biotech and pharma workforce.

India accounts for 20 per cent of global exports in generics. India’s pharma exports stood at $16.84 billion in 2016-17 and are expected to reach $20 billion by 2020. During April – November 2017, India

Pharma industry has been increasingly embracing injectables as a consistently profitable business sector exported pharma products worth `549.56 billion ($ 8.49 billion). By 2024-25, India’s biotech industry is estimated to increase to $100 billion from $11 billion in FY 2015-16.

Brief us on your company and the products manufactured for pharma industry in India LC: IMA’s philosophy is based on research and innovation. For more than 50 years, IMA Group is a world leader in the design and manufacture of automatic machines for processing and packaging of pharma products. Its position of leadership is the result of significant investment in R&D, regular and constructive dialogue with the end users in its sectors and the Group’s ability to expand internationally, conquering new markets.

The IMA Group owns more than 1,600 patents and patent applications in the world and has launched many new machine models over the last years.

Are there any new products

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in the pipeline?

MA: The pharma industry has been increasingly embracing injectables as a consistently profitable business sector, as injectables are the only practical route for the delivery of macromolecules and biologics in particular.

IMA Life aseptic filling lines

for the processing of liquid, powder and lyo products, together with our innovative solution for robotic fill/finish systems to handle ready to fill (RTF) components, are the right response to this need. Considering the continuous growth trend of injectables across the pharma landscape and the

subsequent expansion for related, supporting technologies, IMA Life’s vision looks rosy.

LC: Years of experience and expertise in the industry have been carefully channeled into PREXIMA 800, IMA Active’s tablet press machine suitable for bilayer tableting production.

PREXIMA 800 is designed for high production output, up to 1,044,000 tablets/hour.

Isolation of the processing area, 360° accessibility, exceptionally sturdy structure make Prexima 800 the best solution to handle all powders. swati.rana@expressindia.com

PHARMA ALLY I N T E R V I E W

‘In HP-TLC, each and every parameter that influences the result is controlled’ Akshay Charegaonkar, Director, Anchrom Enterprises, talks about the benefits if HP-TLC in an interaction with Express Pharma

What is the background of Anchrom?

My father Dilip Charegaonkar is India’s first full fledged R&D Analyst who worked in Themis Pharmaceuticals from 1976.

In 1978, he quit to promote TLC when HPLC started coming in. To this day TLC, instrumental TLC (I-TLC) and High Performance Thin Layer Chromatography (HPTLC) are irreplaceable, partly because of Anchrom’s dedicated effort. Since the last nine years, me and later my wife have actively joined him, at Anchrom. This year, is the 40th year of our association with Camag, Switzerland who pioneered HP-TLC.

I-TLC. Is it a new concept?

Instrumental TLC (I-TLC) is halfway between manual TLC and regulatory level HPTLC. I-TLC has all the advantages of instrumentation but the chromatography methodology is not standardised.

What is unique about HP-TLC? The sample is literally ‘visible’ throughout.

Chromatography is done in independent steps. No high temperature or pressure is involved and is fastest of all chromatography methods.

Samples do not come into contact with the chromatograph.

Chromatogram retained on plate. Hence, multiple modes of detection can be applied.

Samples can be cleaned up on the (disposable) plate.

Do you have an application lab?

We do. In fact, Anchrom started the world’s first application lab by a distributor. Ever since it started in 1989, every day we do real life samples analysis.

Our lab is not a show room.

Today, with a little prior discussion and planning, anybody can walk into our lab and we can develop a new method and analyse the sample, entirely new to us, on the same day.

You mentioned about

34 EXPRESS PHARMA April 16-30, 2018

Will HP-TLC replace ITLC? HP-TLC is I-TLC + methodology, so it’s not a replacement but an improvement. In HP-TLC, each and every parameter that influences the result is controlled. However, labs in developing countries will use TLC, I-TLC as well as HPTLC for economic reasons.

HP-TLC is I-TLC + methodology, so it’s not a replacement but an improvement. In HP-TLC, each and every parameter that influences the result is controlled

Is that possible only with HP-TLC ?

PHARMA ALLY

WHAT IS HP-TLC FINGERPRINT? PHYTOCHEMICAL CONTENT REPRESENTED BY IMAGE(S)

Yes. HP-TLC is a ‘safe’ technique, in which the samples cannot damage the chromatograph. Samples remain always on the separating medium i.e. the plate. So any sample is acceptable. Secondly, changing parameters for new method development is easy and several trials can be done in parallel, using appropriate instrument. HP-TLC is done in four to six independent steps, which makes method development easy. The sample is ‘visible’ throughout the analysis. Silica gel is nearly, an universal stationary phase.

Our new method development success rate is >99 per cent in the last 24 years. We are a purely R&D analytical lab.

HP-TLC became official technique only in late 2015. Many labs have multiple HPLCs, not because they have that many samples but because HPLC is a slow, rigid and service prone technique. Imagine a cargo transport company that relies on rickshaws to move goods. More the goods, more autorickshaws and associated paraphernalia. HP-TLC is like a LCV that carries many different consignments of different shapes. HPLC can be fully automated, which makes it popular in developed countries while developing countries should use HP-TLC wherever possible, for cost effective analysis, particularly for generics.

What is the status of HP-TLC today?

HP-TLC is an official pharmacopoeial method in the US, Europe, India etc. and at WHO. Qualitative, semiquantitative fingerprints and quantitative analysis are common aims of HP-TLC analysis. HP-TLCMS hyphenation is official in USP.

Is there a lab anywhere in India, where several HP-TLCs are installed?

Such a situation is rarely going to occur. One HP-TLC System can analyse a hundred samples of different type in a shift. Four or five analysts are required to keep one HPTLC busy. For 200 samples/shift, may be 2 HP-TLCs are required which would require a dozen or two of HPLCs.

Why is HP-TLC considered a costly method?

Not really. HP-TLC requires higher initial investment because even entry level instrument is very sophisticated and capable. It’s incorrect to look only at purchase price. Once purchased, HP-TLC can give the output of 4-5 HPLCs and that too, at a fraction of cost of analysis. Some people wrongly compare HPLC price with HP-TLC. At entry level, HP-TLC is extremely well equipped compared to a skeleton HPLC. Cost per analysis, investment per sample, high sample throughput, negligible maintenance, long instrument life etc. are other factors to consider.

Are you saying HP-TLC is superior to HPLC? Yes, but only where HP-TLC is suitable, e.g. content uniformity test, monitoring the whole Indian pharma market i.e. bulk screening. HP-TLC can double or triple the analysis output based on chromatography results, of all CDSCO and FDA labs.

For materials of botanical origin, HPTLC is indispensable for identification, quantification of markers and detection of adulteration, all by one single ‘HPTLC fingerprint’ test. ‘Identification of botanicals’ is a very big issue, elegantly solved by HP-TLC. Why then we have many labs, using dozens of HPLCs and not HP-TLCs?

Is HP-TLC used in educational institutes?

More than 60 educational institutes have it. We are in the process of installing a large Camag HP-TLC system worth more than a crore rupees at the Bombay College of Pharmacy, for research activities.

How does HPLC compare with HP-TLC? They are two different but complimentary techniques. Each has its advantages and limitations. There is no reason for comparison.

How do you see the future of HP-TLC? Wear your goggles! Jokes apart, the future is very bright. HP-TLC is a new technique that is simple, high throughput, visible, low analysis cost and little maintenance. Smarter the analyst, sooner will be the purchase of HP-TLC in that lab. But you need to follow USP Chapter 203 SOP, for great results. Being flexible, HP-TLC is equally useful in R&D and QC. The implications of being an official method will be very visible from the next two to three years.

Already about 500 labs use HPTLC in India. Our lab will now systematically develop new Indiaspecific methods of analysis.

EP News Bureau

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April 16-30, 2018

HP-TLC Fingerprint is a simple, rapid, low cost, yet a powerful, easy-tounderstand pharmacopeial technique, with innumerable applications in herbal extracts, medicines, foods, neutraceuticals, functional foods. In all these samples, the raw materials are very complex and variable but no problem for HP-TLC fingerprint analysis.

Extraction of material of botanical origin for fingerprint analysis: 100mg sample in 1ml methanol. Sonicate for 15mins.

Centrifuge. Use supernatant.

Sample Application Pattern On Plate:

70mm

Chromatogram Development: 33% RH, develop 70mm, 20min chamber saturation, paper lining, dry vertically

UV 254nm

UV 366nm

Visible

Visible Derivatised

Evaluation: BRM vs Sample

BRM Sample Fail (less no. of bands)

BRM Sample Pass (identical bands)

BRM Sample Fail (one band extra)

HP-TLC Fingerprint evaluation i.e. comparison between Botanical Reference Material fingerprint and sample(s) for Rf, colour and intensity of bands, using GLP compliant auditable data. Less or more no. of bands means adulteration or substitution and fails the sample. Otherwise identical to BRM, but weaker bands indicate dilution.

HP-TLC Specialist!

For live demo, details & free training: hptlc@anchrom.in 9833830899/9833830898

PHARMA ALLY I N T E R V I E W

Next-generation business intelligence will bring new wave of automation in business processes In India, technology in pharma logistics is still at its nascent stage and there is a dire need for technology enabled and process managed cargo storage which can facilitate operations more efficiently. V Raju, VP, Contract Logistics – Pharma, Chemical and Food Avvashya CCI Logistics talks about the issues faced by the industry and shares his company’s growth plans, in an interaction with Usha Sharma

There is a dire need for high technology enabled and process managed cargo storage and handling facilities to operate efficiently in India, which calls for high investments. A long-term investment strategy is needed for augmenting the country’s warehousing, ground handling, storage, IT infrastructure and transportation capabilities

36 EXPRESS PHARMA April 16-30, 2018

Tell us about Avvashya CCI Logistics’ services for the pharma sector?

Avvashya CCI (ACCI) is involved in safe storage of pharmaceutical material for its pharma customers at some of its warehouses.

These involve good storage practices in temperature controlled, racked storage facilities with FDA approvals, temperature data loggers, and implementation of all other safety and security PPEs. Enough care is taken to monitor storage practices and enable good and safe handling methods, as these go hand in hand to ensure excellent storage practice for pharma manufacturers and exporters. Realising the importance of supply chain and logistics, ACCI ensures that along with storage of pharma products in its warehouses, all facilities for exports like handling and stuffing export containers with desired pharma products is done as and when required, in time for exporters to move the material/containers safely and soundly to the ports. All value additions required for packages to become ship fit and export fit are also done at ACCI facilities. This goes a long way in having an extremely satisfied pharma customer.

Recently, you have commissioned a new warehouse in Bhiwandi. Tell us more about the facility.

The warehouse is predominantly for chemical companies, located at Renaissance Logistics Park, WB-09 Bhiwandi. Spread across 1.31 lakh sq ft, the warehouse meets global standards in safety and security compliances. The facility functions on a multi-client mode and has a clear height of 10 meters, with mid height being 11.5 metres and fully racked with a capacity of 10,776 pallet positions.

What is the USP of Allcargo Logistics,

which is a part of Avvashya Group? In terms of geographical connectivity, tell us the advantages it offers?

The company’s product offerings range across the logistics value chain from NVOCC, container freight stations, inland container depots, and projects and engineering solutions. Through ECU Worldwide, the group is the global leader in the Less than Container Load (LCL) segment and has footprints in more than 160 countries and over 300 offices thus ensuring a strong international foothold. ACCI on the other hand has a strong India presence in 3PL Contract Logistics (warehousing) with close to 3.5 million sq ft space being owned/managed by them and supported strongly with their own customs clearance and freight forwarding divisions.

The group thus has a unique advantage of logistics solutions provided through the various business verticals under one roof, dominated by expertise and network, both in India and internationally, which can be leveraged to provide customised end-to-end services to clients. Nowadays, a lot of companies are outsourcing their logistics requirements. To deal with a reputed group like ours, would mean one-stop-solution for all logistics requirements.

What safety and compliance measures does one need to adhere to in a pharma warehouse?

Pharma warehouses require certifications from FDA and other certification bodies like SGs etc. on the health, safety and hygiene practices followed in the warehouses. With good infrastructure, Good Storage Practices (GSP), Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) to take care of receipt, storage and distribution being followed at its warehouses, ACCI

PHARMA ALLY ensures that the best of supply chain logistics services are offered to its customers at all times.

Our warehouses meet global standards in safety and security compliances. Time bound delivery is critical in the pharma logistics domain. The company also strictly ensures compliance with the Environmental, Health and Safety (EHS) guidelines and environmental regulations.

What are the challenges being faced by the Indian pharma logistic industry and how to overcome those?

Time bound delivery is critical in the pharma industry. Most pharma products need to be kept at a particular temperature throughout the transit period from the manufacturer to the end user. This is to make sure that the drugs are useful for the patients. Transporting pharma products, be it through the air, sea, road or railways, each has its distinct advantages as well as disadvantages.

Quality issues and price pressures have also spiraled across the value chain, triggered by more regulatory scrutiny. Infrastructure ,although better than in the past, is still a serious concern.

Along with infrastructure issues, handling of pharma cargo through transshipment ports and transshipment points is also an issue in our country, where inadequate training or care on the part of site staff can lead to supply chain logistics problems. Lack of IT sophistication in the domestic logistics sector with the limited use of RFID sensors and technological tools, has made it difficult for manufacturers to execute basic tasks like tracking cargoes.

Supply chain management is a key concern in the pharma industry.

Will cloud-based platform be a solution?

Big data and data analytics can help identify patterns for future predictions. For instance, marketing and sales forces could deploy advanced analytics to understand prescribing behaviour and potential patient profiles, enabling more precise targeting of providers and increasing the number of prescriptions filed.

Cloud and mobile technology, sensors, and next-generation business intelligence will bring about a new wave of automation in business processes—that is, real time responsiveness though streamlined, automated work flows with few handovers and end-to-end, real-time

transparency on progress, costs, and business value. Thus, cloud based platform could be a viable solution for efficiencies in supply chain logistics.

Technology is still at its nascent stage in the industry, especially in India. There is a dire need for high technology enabled and process managed cargo storage and handling facilities to operate efficiently in India, which calls for high investments. A long-term investment strategy is needed for augmenting the country’s warehousing, ground handling, storage, IT infrastructure and transportation capabilities. These technology solutions will have to be supplemented with human intervention, at least in the near term to ensure efficiency. A combination of human and digital process would help put together a robust system of supply chain logistics.

Recently, the Finance Ministry has granted sub-sector status of infrastructure to logistics sector. Do you think this will give a boost to the sector?

It is a very positive move for the sector and is expected to boost competitiveness making it feasible for companies to raise long-term credit from banks and financial institutions at low rates, and attract foreign investment. The infra status accorded compliments the recent landmark tax reform - GST. Growth in consumption will significantly scale up manufacturing growth, leading to creation of more jobs, further boosting economic activity.

What do you say regarding GST? Will it be a boon for the sector?

With implementation of GST, over a period of time, logistics cost to GDP is expected to come down to around 10 per cent from current levels of 13-14 per cent. Delivery time from manufacturers to consumers, which earlier took 10-15 days due to multiple check-posts, has gone down to three to five days optimising the time and saving the costs. Supply chain cost across customer organisations and industry at large is expected to see significant savings. This is a very significant contribution as logistics is a part of every business and an integral part of the economy. Short-term glitches like IT infrastructure, etc. still persist, but over a period of time, all stakeholders will eventually align with the revised system and this will prove beneficial to the sector.

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u.sharma@expressindia.com

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April 16-30, 2018

PHARMA ALLY VENDOR NEWS

Waters newACQUITY UPLC PLUS series sets new performance benchmarks Next-generation UPLC platform designed to keep pace with evolving laboratory requirements for chromatographic performance WATERS CORPORATION announced the introduction of the ACQUITY UPLC PLUS Series, three new ACQUITY UltraPerformance LC (UPLC) Systems that build off of the success of Waters’ industry-leading ACQUITY UPLC separations platform. By embracing a philosophy of continuous product improvement, along with customer feedback, Waters designed the new ACQUITY UPLC H-Class PLUS, H-Class PLUS Bio, and IClass PLUS Systems for unparalleled flexibility, performance and ease-of-use. From applications as complex as peptide mapping to routine product release testing, ACQUITY UPLC is helping thousands of academic, pharmaceutical, food, and chemical industry laboratories meet their research, development and quality control objectives. ACQUITY

UPLC PLUS Systems made their industry debut at the Analytica Conference in Munich, Germany.

“When introduced in 2004, the ACQUITY UPLC System transformed laboratory science by bringing dramatic business and scientific benefits to the analytical process. And it was met with overwhelming customer acclaim considering it had been 30 years since liquid chromatography saw such dramatic performance improvements,” said Eric Grumbach, Director, Product Marketing, Chromatography Systems. “At Waters, innovation is about more than just performance. It’s about listening to the customer and continuously pushing our LC technology forward to find faster, simpler, and better ways to support the work that they do.”

The ACQUITY UPLC HClass PLUS and H-Class PLUS Bio Systems are quaternary UPLC systems designed for high-resolution, high-sensitivity separations of complex samples with the flexibility and robust-

ness to run all modes of chromatography – ion exchange, size exclusion, hydrophilic interaction, hydrophobic interaction, and reversed phase – independent of the type or size chromatographic column particle the method specifies. These systems are especially well-suited as an inlet to mass spectrometry, for streamlined method development, and for routine analysis laboratories running HPLC, UHPLC or UPLC analytical methods. The ACQUITY UPLC IClass PLUS System is a binary UPLC system designed to generate ultra-efficient, narrow peaks and to improve the sensitivity of optical detection or mass spectrometry. With industry-leading, ultra-low dispersion and delay volumes, it is an ideal system for laboratories seeking the highest chromatographic resolution and

productivity possible in a UPLC system.

The ACQUITY UPLC HClass PLUS, H-Class PLUS Bio, and I-Class PLUS replace the Waters ACQUITY UPLC HClass, ACQUITY UPLC H-Class Bio and ACQUITY UPLC IClass Systems in Waters product line. The foundational enhancements made to the ACQUITY UPLC PLUS Series will not affect the analytical results for well-established, validated LC methods developed with the ACQUITY UPLC H-Class, H-Class Bio and I-Class Systems. For laboratories that wish to extend the lifecycle of their investment in previously-installed systems, Waters is offering ACQUITY UPLC PLUS Series Usability and Performance Enhancement Kits.

EP News Bureau

CBCC Global Research to introduce medical writing CBCC Global Research sets the benchmark for medical services with its principle pattern of working with the client and other such company policies CBCC GLOBAL Research is an oncology focussed Contract Research Organization (CRO) supporting global bio-pharmaceutical companies. They do this by advancing research by offering clinical operations, data management & statistical services, QT/QTc and PK studies, imaging core lab and bio-repositories.

Recently, CBCC has introduced medical writing services by well-trained and globally experienced in-house medical writers as a business unit to further become an entrusted platform for its customers.

“We are zooming in on med-

38 EXPRESS PHARMA April 16-30, 2018

ical writing services for the next three years to assure that we strike the right market with our inclined qualities that we have maintained over the past 30+ years,” says Manoj Vyas, CEO, CBCC Global research. “For the same, we have on-boarded Ivan D’souza who has joined us to lead this business unit. Known for his flair in this field, we are expected to make bigger investments and have experienced scientific talent under his leadership.”

Meanwhile, Ivan D’souza, Director of Medical Writing, CBCC global says, “It is not just

the quality that the company is focussed on but through the expertise of well-trained global medical writers, CBCC intends to build trust among its customers and cancer patients.”

CBCC Global Research sets the benchmark for medical services with its principle pattern of working with the client and other such company policies. Dr Bina Naik, COO, CBCC Global says, “With the increasing need to innovate quality drugs, we aim to serve a larger audience with our medical writing service, knowing that we have been able to provide end-

to-end services to our existing clients in 1000 successful clinical trials. We have built our foundation following patientcentric and thorough-transparency philosophy and we shall continue the same as we grow.

Our depth to empathise and being approachable justifies the expansion in our services.”

The CRO provides flexibility, capacity and dedicated resources along with a notable save in time and costs. It adheres to the follow-the-sun delivery model across different time zones to meet client’s expectations within timelines and

be transparent as well.

Come to speak of the company’s growth and them foraying into the field of medical writing, Dsouza says, “By the end of 2019, we aim to increase this number (CBCC’s number of medical writers across the globe) to 150+ well trained medical writers. Knowing the potency of CBCC as well as of the medical writing service, we are aligned to meet the client’s needs through our customisedsolution-based-approach on disseminating scientific information.”

EP News Bureau

PHARMA ALLY

VICAM Introduces new method for BPAdetection BPATest enables food and agricultural laboratories to isolate and purify BPA for analysis in as little as ten minutes WATERS CORPORATION announced VICAM, a Waters Business, introduced a sensitive, precise determination of Bisphenol A (BPA) for food and agricultural laboratories.

VICAM’s BPATest quickly isolates and purifies BPA for analysis from 0.1 to 50 parts per billion in as little as ten minutes total preparation time.

BPA is a chemical which has been used to manufacture food packaging materials and coatings. Research studies indicate that BPA may be an endocrine disruptor and reproductive toxicant and may also contribute to serious diseases such as diabetes, heart disease and even cancer. To protect human health, the use of BPA in baby bottles, sippy cups and infant formula packaging is prohibited by law in the US, Canada, EU and several nations across Asia.

BPATest pairs im-

munoaffinity chromatography with liquid chromatography (HPLC, UPLC) and fluores-

cence or mass spectrometry detectors to accurately detect levels of BPA with a higher

level of certainty, without compromising laboratory efficiency and productivity. The

proprietary monoclonal antibody in VICAM’s immunoaffinity columns efficiently transforms test samples into highly concentrated BPA extract. As a quantitative method that outperforms solid phase extraction and ‘dilute-and-shoot’ techniques in both sensitivity and specificity, BPATest offers a forward-looking solution to emerging market and compliance demands.

“Worldwide efforts to minimiSe the impact of BPA on the population, consumer confidence and trade revenues continue to evolve toward even tighter control measures worldwide,” said Marjorie Radlo-Zandi, MD, VICAM. “BPATest serves laboratories in their pursuit of analytical excellence in empowering food manufacturers and regulators to safeguard human health.”

EP News Bureau

Safexpress to invest ` 100 crore in Northeast The announcement made at ‘Advantage Assam Global Investors Summit’ SAFEXPRESS HAS announced the biggest-ever investment by a Logistics Company in the Northeast region.

At the occasion of the Advantage Assam Global Investors Summit being held recently in Guwahati, Rubal Jain, MD, Safexpress addressed the media.

Safexpress, which has the largest Logistics Network in Northeast, was representing the Logistics industry at the Summit. Out of the 12 focus industries identified by the Government for investment in Northeast in general and Assam in particular, Logistics is one of the major industries.

Rubal Jain, MD, Safexpress is seen as an icon in Logistics in-

dustry, and hence was the flagbearer of the industry at this very prestigious Summit.

Speaking to the media, Jain said, “On this momentous occasion, we are pleased to announce an investment of ` 100 crore in the Northeast region. We whole-heartedly support this wonderful initiative by our Prime Minister, Narendra Modi to boost investment in this region. We also sincerely compliment the Chief Minister of Assam, Sarbananda Sonowal, the Minister of Industries & Commerce, Chandra Mohan Patowary, as well as several other people who have collectively worked very hard to bring Northeast to the cen-

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trestage of investment.”

Jain added, “Northeast is one of the most amazing parts of India. The region is home to more than 45 million people and has unsurpassable beauty.

Assam, the biggest state in this belt, has evolved itself over the years from being a traditional state to a competitive business hub. Assam is also a very crucial location from the point of view of logistics connectivity of Northeast India with the rest of the country. The development of strong ASEAN relationships with Northeast is a great boon for the entire region and all business entities serving the region.”

Speaking at this occasion, Vineet Kanaujia, VP – Market-

ing, Safexpress said, “Given the vital role Assam plays in connecting Northeast to the rest of the country, Safexpress has recently built up an ultramodern Logistics Park at Guwahati. We have invested ` 30 crore in creating this state-of-the-art logistics park at Guwahati. This facility spans over an area of more than 1 million square feet, and is located strategically on National Highway 31. This logistics facility is functional 24x7x365 and ensures excellent connectivity of Northeast with the rest of India.”

Explaining about the massive logistics network created by Safexpress in Northeast, Kanaujia said, “North-

east has always been a very high priority region for us. We have offices across the whole of Northeast region. Our logistics network covers even the remotest of the locations, and we cover every square inch of Northeast. Given our massive logistics network within Northeast, we deliver to all 1001 pincodes in Northeast. With a huge investment of ` 100 crores planned by Safexpress for the region in the field of logistics, we intend to contribute hugely in the Northeast growth story, given the massive role logistics needs to play in the growth of this region.”

EP News Bureau

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April 16-30, 2018

PHARMA ALLY PRODUCTS

Romaco displays Innojet IHD series at ACHEMA2018 ROMACO INNOJET has launched the first GMP compliant hot melt coating device specifically for use in the pharmaceutical industry. The IHD series for processing hot melt coatings can be supplied as a laboratory or pilot scale machine.

The IHD series from Romaco Innojet was specially designed for coating and granulating pharma products with hot greases and waxes. GMP compliance was a key development priority for these CIP capable devices, particularly regarding the validation of the cleaning processes. All sealing points,

The IHD series from Romaco Innojet was specially designed for coating and granulating pharma products with hot greases and waxes gaps and enclosed spaces were eliminated for this reason and flange connections reduced to a minimum. The hot melt coating flows through straight tubes to prevent any build-up of product residues. All product-contacted surfaces inside the IHD devices are positioned in such a way that they are fully visible and suitable for swab testing. Once the device has been cleaned, it can be opened up quickly and easily for inspection. The Romaco Innojet IHD series suc-

40 EXPRESS PHARMA April 16-30, 2018

cessfully avoids cross-contamination thanks to the hygienic design with no dead spaces.

To allow precise and uniform heat distribution, the Innojet IHD was designed as a heatable monobloc integrating all functional components. The melting container, dosing unit and valve block are all included in the same thermal cycle, which means they do not have to be heated and insulated separately.

The compact hot melt coating devices are connected via a trace heated tube to the processing machines in the Romaco Innojet VENTILUS series whenever this is required by the application. The Innojet IHD feeds the hot melt with a pulsation-free dosing piston as standard, so that the coating is applied to the product absolutely evenly. The central bottom spray nozzle on the Innojet machine enables both the temperature and the size of the droplets with which the product particles are coated to be precisely defined. The Romaco Innojet air flow bed technology ensures homogeneous and controllable flow conditions in the container of the processing machines. The laboratory scale version of the hot melt coating device (Innojet IHD 5) is designed to handle batches of up to 5 litres while the pilot scale machine (Innojet IHD 50) can process up to 50 litres.

Benefits of hot melt coated formulations Innojet’s IHD technology lets pharma manufacturers reap the previously unattainable benefits of hot melt coatings.

Unlike aqueous alternatives, hot melt coatings contain no solvents which would have to be evaporated again after they have been sprayed on. Hot melt coatings solidify directly

on the product, resulting in up to 85 per cent shorter processing times. Less spray is required for hot melt coating processes because the formulations are solvent-free. What’s more, since there is no need to heat the air in order to dry the product, energy efficiency is improved. Hot melt coating is not only an extremely economical and efficient production process; it is also very versatile, for example for moisture barriers, taste masks or delayed API release.

Contact details Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany T +49 (0)721 4804 0 F +49 (0)721 4804 225 E susanne.silva@romaco.com

PHARMA ALLY

Gandhi Automation’s clean room high speed doors a necessity BETTER QUALITY or better yield is the primary reason for investing in a cleanroom space. It goes straight to the bottom line. Numerous manufacturing facilities now require a controlled environment in which one can limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. One needs to know the requirement for specific product or process. Clean rooms have become integral part of pharma manufacturing facilities.

One of the most important aspects of cleanrooms is the doors which needs to be chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility.

Gandhi Automations provide clean room high speed doors specifically designed for above purpose.

The clean room high speed doors are best suited for facilities when there is a requirement of controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility.

High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA . ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, India Off: +91 22 66720200 / 66720300(200 Lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website : www.geapl.co.in

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April 16-30, 2018

PHARMA ALLY

Sciex launches OptiFlow Quant Solution for biopharma peptide quantitation SCIEX, A global leader in life science analytical technologies, introduced the OptiFlow Quant Solution for easy yet highly sensitive biomolecule quantitation. This latest addition to the growing line of SCIEX solutions for biopharmaceutical laboratories comprises the new M5 Microflow LC with Phenomenex microflow columns and new OptiFlow Turbo V Source. It offers scientists the most flexible microflow quantitation solution with better sensitivity than analytical flow systems, but without sacrificing robustness or usability.

Pharmaceutical, biopharmaceutical and contract research organisations (CRO) currently struggling with bioanalysis projects on challenging analytes, such as peptides, mAbs, and ADCs, will now be able to obtain better data while achieving maximal throughput by utilising microflow separations, without the traditional complex setup and impact of low flow workflows.

Development of novel therapeutics and biotherapeutics creates a challenge for scientists to accurately detect and quantify these compounds. Researchers are tasked with developing quantitation methods that are both sensitive and selective enough to be used in bioanlaytical studies to support drug development. The OptiFlow Quant Solution from SCIEX brings the powerful sensitivity boost from microflow LC without sacrificing the ease-of-use and robustness of analytical flow assays. Scientists are able to gain sensitivity of analyte detection with an easy to implement setup,that still provides maximal flexibility to ensure it can handle novel therapeutics coming through the pipeline in the future.

42 EXPRESS PHARMA April 16-30, 2018

The OptiFlow Quant Solution from SCIEX brings the powerful sensitivity boost from microflow LC without sacrificing the ease-of-use and robustness of analytical flow assays

The SCIEX new OptiFlow Quant Solution comprises: ◗ M5 Microflow LC - The new microflow LC now has flow rate capabilities from 1200 µL/min flow ranges, along with an auto-sealing injection needle, updated auto sampler with injector wash pumps and vial bottom sensing technology. Standard size, finger-tight fittings make the setup and use of the M5 Microflow LC simple and tool-free. ◗ Phenomenex MicroFlow Columns - SCIEX has partnered with Phenomenex, which has a wide portfolio of microflow columns across a large number of column chemistries, to give flexible column choice for all project needs. ◗ OptiFlow Turbo V Source The new single-click source is based on the market leading Turbo V Source technology and requires no physical adjustments for optimal ionisation performance. The OptiFlow Turbo V Source supports a wide flow rate range, and includes a column heater that goes up to 900C for challenging analyte separations, and utilises standard size finger-tight fittings for a toolfree setup. ◗ 6500+ Triple Quad or QTRAP MS Systems Paired with an industry leading SCIEX mass spectrometer, the OptiFlow Quant Solution offers proven sensitivity and robustness with compliant software processing for even the more regulated environments. These high performance MS systems empower users with the highest quality data and uptime for the entire study.

Contact details Victoria Parr Global Marketing Director, SCIEX Victoria.Parr@sciex.com

PHARMA ALLY VALUE ADD

Virosil Pharma: ASwiss eco-friendly disinfectant Sanosil Biotech has pioneered the novel concept of eco-friendly fumigation in sterile areas SANOSIL BIOTECH, a Mumbai based company is the first company to pioneer the novel concept of eco-friendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colourless, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared.

Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, SunPharma, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water

tanks and pipelines – can now be pathogen free.

What’s more, there’s no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely decomposes into water and oxygen.

The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India.

MIC determination Method Based on modified BSEN1276 (antifungal), BSEN 1650 (antibacterial) Objective: To determine the minimum inhibitory concentration (MIC) of Virosil against standard microbial cultures.

Objective Test organisms: 1) Escherichia coli ATCC10536 2) Staphylococcus aureus A TCC6538 3) Pseudomonas aeruginosa ATCC9027 4) Candida albicans ATCC 10231 5) Aspergillus nigerATCC 16404

Inference: 1.) The Minimum inhibitory Concentration of the disinfectant sample Virosil was determined at different concentra-

How effective is it?

Even at low dosages,Virosil Pharma has the power of penetrating bio-film and killing the actual bacteria, thereby providing a long residual level of disinfection

How safe is it?

Even at low dosages,Virosil Pharma has the power of penetrating bio-film and killing the actual bacteria, thereby providing a long residual level of disinfection

VIROSIL PHARMA For bacteria- free surface & Pipelines How does it compare to chlorine?

Virosil Pharma is superior to chlorine since it imparts no taste or odour to the water and is highly effective at both hot and cold temperatures

tion – contact time combination and against 5 different standard microbial respectively.

The Criteria for passing the MIC was chosen as > 5 log reduction in Bacterial counts (BSEN 1650) > 4 log reduction in Fungal counts (BSEN 1276) 2) Virosil was effective in inhibiting all bacterial and fungal cultures under study, at a contact time of 15 minutes and concentration of 5 per cent

How does it work ?

H2O2 is a strong oxidising agent (more powerful than chlorine or chlorine dioxide).The oxygen separated from H2O2 destroys the biofilm, enabling the silver to help destroy any bacteria or virus.

comes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria populations.

The company also offers a customised disinfection audit on its website;

Disinfecting biofilms using Virosil Pharma Virosil Pharma not only successfully penetrates bio-films and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines.

Using Virosil Pharma over-

www.sanosilbiotech.com Contact details Dev Gupta, CEO, Sanosil Biotech Warden House, 1st floor, Sir PM Road, Fort, Bombay 400 001 Tel No 022 22872295 / 43112700 / +919820016292 email: info@ sanosilbiotech.com

RESULTS TABLE 1- COUNT OF STANDARD CULTURE INOCULUM USED Standard Culture

CFU/ml

Log Value

S. aureus

400000000

8.6020

P aerugilosa

380000000

8.5797

E coli

370000000

8.5682

C.albicans

99000000

7.9956

A niger

88000

4.9444

RESULTS TABLE2- MICROBIAL COUNTS POST DISINFECTANT EXPOSURE IN CFU/ML Microbial Counts in CFU/ml

Microbial Counts in Log Values

Log Reductions

Log Reductions

Virosil 5%

Virosil 5%

Virosil 5%

Virosil 5%

Test Organism 3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

3 mins

15mins

30 mins

S. aureus

37000

1000

50

4.0338

5.6020

6.9030

4.5682

3

1.6989

99.99

99.9997

99.9999

P aerugilosa

75000

<10

<10

3.7047

>8.5797

>8.5797

4.8750

<1.0000

<1.0000

99.9802

>99.999

>99.999

E coli

42000

<10

<10

3.9449

>8.5682

>8.5682

4.6232

<1.0000

<1.0000

99.9886

>99.999

>99.999

C albicans

<10

<10

<10

>7.9956

>7.9956

>7.9956

<1.0000

<1.0000

<1.0000

>99.999

>99.999

>99.999

A niger

10

<10

<10

3.9444

>4.9444

>4.9444

1.0000

<1.0000

<1.0000

99.9886

>99.99

>99.99

Highlighted values indicate MIC achieved as >> 4 log reduction in fungal counts (BSEN 1276) 5 log reduction in Bacterial counts (BSEN 1650)

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Delivery of liquid formulations by fills in hard two piece capsules With changing trends in the pharmaceutical industry, encapsulation technology has undergone a major change in the recent past. The challenge of the encapsulation technology is no longer restricted to solid formulations but has also extended to simple liquid and highly viscous semi-solid formulations. Liquid fill hard capsule technology is being increasingly accepted by the pharma industry and is expected to replace more conventional dosage forms such as tablets and powder-filled capsules. Dr Jnanadeva Bhat and Dr Surya N Singh, give an insight THE WORD ‘Capsule’ is derived from the Latin word ‘Capsula’, which means a small box or a container. Gelatin capsules were invented in the early 19th century. The hard gelatin capsule has historically been used as a dosage form for pharmaceutical and nutraceutical products that are formulated as powders or pellets. Liquid fill hard gelatin capsule technology was established in the early 1980s as an alternative to soft gelatin capsules. The technology offered a number of specific advantages such as lower moisture and gas transmission, permitting the use of high melting point excipients, freedom from plasticisers and preservatives, lower moisture content, ease of coating and choice of capsule composition (gelatin and hydroxypropylmethylcellulose, HPMC) (1-3).

Until recently, soft gelatin capsule was the only dosage form available to encapsulate liquid and poorly water-soluble drug formulations in liquid vehicles (4). For example, liquids like simple oils, semi-solids, suspensions, microemulsions, and nanosuspensions are major products, which are filled in soft gelatin capsules. To keep pace with the changing trends, ACG has introduced liquid filling and band sealing technology solutions. This technology enables the use of hard capsules (hard gelatin capsules or HPMC capsules) as an alternate dosage form to soft gelatin capsules for filling liquid/semi-solid formulations. This not only makes the

44 EXPRESS PHARMA April 16-30, 2018

is very helpful with respect to patient compliance as it is available as a single formulation for treating both ulcer and rheumatoid arthritis.

Comparison of hard capsules over the soft gelatin capsules

Flofit liquid filled capsules

encapsulation process easy and cost-effective but also eliminates numerous manufacturing and stability concerns associated with soft gelatin capsules.

After liquid filling, hard capsules would need to be band sealed in most of the cases.(5) Therefore, one has to make use of a stand-alone band sealing machine. The output of the automatic liquid filling machine is maximum 40,000 capsules/hour and corresponding band sealing machine with 70,000 capsules/hour output.

Both the liquid filling and band sealing machines are available in R&D model as well as in production model. Both the machines are designed as per GMP standards.

Importance of hard liquid encapsulation technology Technological perspective This technology has advantages over the soft gelatin cap-

sule such as in-house development and manufacturing, small batch production, scale up and combination filling. This technology can make a significant contribution to the overall development of efficacious pharma products.

Pharma perspective This technology provides flexibility to the pharma formulation scientist for rapid development of new formulations and processes, which can be easily scaled up. The process is easy to handle with no containment of dust in and around the processing area as observed in conventional tablet and powder fill capsule processes. For example, this technology has been used for conversion of non-micronised form of Piroxicam to solubilised oily liquid formulation in hard capsule. Piroxicam is available in liquid form. It is believed that the liquid form

has better absorption (with immediate onset of action) in comparison with the commercially available powder filled capsules. Therefore, liquid filled capsules could be developed more cost-effectively with better quality and quantity. After the successful formulation of piroxicam as liquid-filled capsules, a combined formulation of Piroxicam and Rabeprazole was also developed using this technology.

Commercial perspective First, band sealing renders the capsule tamper-proof, preventing counterfeiting in the marketplace. Second, as can be seen from the example of Piroxicam liquid filled capsules, the process required lesser steps during development and manufacturing. This ultimately led to a shorter time to market. Further, the combined formulation of Piroxicam and Rabeprazole

In case of hard capsules manufacturing process, pre-fabricated two piece empty hard gelatin/HPMC capsules are used for encapsulation process.

Whereas, in case of soft gelatin capsule process, the capsule shell formation and encapsulation take place simultaneously.

The moisture content of the gelatin ribbon at this stage is around 30 per cent to 50 per cent and, the equilibrium moisture content is achieved only after several hours of drying and can stretch up to several days based on the formulation. During this period, migration and degradation can occur for few molecules either due to the presence of plasticiser in the shell or due to the higher moisture content in the shell before reaching equilibrium moisture content.

In contrast to hard capsule, the soft gelatin capsule contains a plasticiser (usually glycerol in approximately 15 per cent-30 per cent level) in addition to gelatin and water. As a result, the moisture uptake of soft gelatin capsules is considerably higher than that of hard capsules due to hygroscopic nature of glycerol. Another disadvantage in the usage of the plasticiser is that it aggravates migration of

PHARMA ALLY TECHNICAL COMPARISON BETWEEN SOFTGEL CAPSULES AND LIQUID FILL HARD CAPSULES ASPECT

SOFTGEL CAPSULES

In-house development and manufacture

Complex operation, difficult for in-house production

Yes

Small batch production

Cumbersome

Possible

Scale-up

Requires large quantities of drug substance and must be outsourced

Simple and in-house

Combination Filling:Liquid and Pellets

Not possible

Possible

Partial filling

Not possible

Possible

Permeability of shell to oxygen

High due to plasticiser and moisture content

Low permeability and no plasticiser required

Temperature of fill

Maximum 35ºC

Maximum 70ºC

Limitation on excipients for the formulation

Hygroscopic excipients can be tolerated due to the presence of plasticiser in the shell

High concentration of hygroscopic excipients, such as glycerol/propylene glycol/ liquid PEG, can be avoided

Risk of drug migration

High – for drugs soluble in plasticiser

Low

a drug from fill to shell, which ultimately results in chemical instability due to drug loss and degradation.

Advantages of hard capsules over the soft gelatin capsules Oxygen transmission/permeability rate The oxygen transmission/ permeability rate of a soft gelatin capsule is proportional to the level of glycerol in the film and moisture content. As a hard capsule contains no plasticiser, the permeability of capsule wall is lower than that of the wall of a soft gelatin capsule.

As a result, hard capsules containing even highly odorous products like fish oil, valerian oil, and garlic oil can be rendered odorless.

Dark spot The dark spot on the soft gel capsule is an inherent problem, which occurs due to the basic nature of the encapsulation operation. This poor aesthetic issue of the drug product is a cause of worry for most of the brand owners. This problem is completely eliminated when the liquid formulation is encapsulated in hard capsules and band sealed. Moreover, it adds to the aesthetics of the product, offering a flexibility of colour and type of pre-printed capsule.

Contract manufacturers The soft gelatin encapsulation process is usually outsourced to contract manufacturers due to the complexities of the process. Pharma companies rarely get involved in this operation. This means that from an early stage development, all ac-

tivities must be contracted out.

Many companies would prefer to keep these activities in-house for reasons of confidentiality, control over the development process, availability of drug substance at the early stage development trials and control over cost and quality. This is possible by adopting the new concept of liquid filling in hard capsules and band sealing.

In-house formulations This technology can make a significant contribution to the overall development of efficacious pharma products. This technology provides the flexibility to rapidly develop and test in-house formulations when only small quantities of drug substance are available at initial pre-formulation and lab scale development stage.

The process can be scaled up and also kept in-house similar to the operations of tableting or powder/pellet filling of hard gelatin capsules.

The added advantage of this technology is extended to the very beginning of the development stage. New concepts can be evaluated for feasibility studies in an R&D lab without the involvement of in any machinery. The concept can be tried by filling capsules with a syringe and banding manually with the minimum amount of formulation. This is especially useful when the availability of API is restricted, or the API is available in small quantities, or the cost of API is exorbitantly high.

Development advantage of liquid filled hard capsules over soft gelatin capsules Conventionally, the hard gelatin

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capsule has been used as a solid dosage form product, formulated either as powder or pellets. However, the market demands new and different ways of formulation to be developed and launched as quickly as possible. Liquids filled hard capsules can fulfil some of these demands. This is especially true for drugs, which are inherently liquid or semi-solid. This new concept can bring down the overall development time and, thereby, time to market.

Low melting point Materials that have low melting points or are liquid at room temperature present difficulties when formulating as dry powders or tablet dosage form and often require high concentrations of excipients to avoid processing problems. The manufacturing process can be considerably simplified (fivestep process to manufacture a tablet can be reduced to a simple mixing and filling operation) by filling as a hot melt into a hard capsule. Consumer acceptance is also enhanced due to the smaller size of the final dosage form. Products such as Validol tablets are made into solid dosage form by converting 60mg/100mg of liquid (Validol) with the addition of colloidal anhydrous silica (Aerosil 200) as a diluent or adsorbent, which can be directly filled in a hard capsule without any excipients.

Low dose/high potency Drugs in this category present two major challenges: achieving acceptable content uniformity and how to control cross-contamination and personnel protection. Invariably in

HARD CAPSULES

a true solution format, the content uniformity is not a major concern. Further, owing to lesser/no dust formation, the chances of cross-contamination are reduced considerably.

The liquid filling operation is capable of achieving fill weight variations of < 1%, especially if the drug product is in the form of true solution, microemulsion or uniformly dispersed stable suspension or nanosuspension in an oily vehicle. This contributes to the content uniformity of the finished dosage form in both fill-in hopper and in the encapsulated capsules due to volumetric filling principle (e.g.: Triamterene 25µg).

Companies manufacturing solid dosage forms of hormones and cytotoxic agents from powders are forced to install extremely elaborate systems (isolators) to reduce contamination. Incorporation of the highly potent drug substance into a liquid vehicle for filling into a hard capsule can reduce the dangers during handling such drug molecules.

Poor bioavailability The bioavailability of the poorly water-soluble drug, such as Digoxin, could be significantly enhanced when formulated as a liquid in a hard capsule. This increases the effectiveness and efficacy of the drug.

Stability Sensitivity to moisture is an aspect of drug substance and drug formulation, which can be minimised by incorporating the drug into either a hydrophilic or lipophilic matrix. For example,

the Macrolid antibiotic, Vancomycin Hydrochloride, is a highly unstable molecule. To achieve acceptable stability, it requires to be formulated as a hot melt with a solid PEG matrix and filled in hard capsules.

Sustained release By choosing appropriate excipients, the release property of a drug product can be modified.

For example, Gelucire, which is available as a semi-solid with a range of melting points and HLB values, can be mixed to obtain different release profiles.

References 1. Bowtle W, Materials, process and manufacturing considerations for lipid-based hard-capsule formats, Lipid-based formulations for oral drug delivery, Ed: D Hauss, Informa Healthcare, New York: pp 79-106, 2007.

2. Cole ET, Challenges and opportunities in the encapsulation of liquid and semi-solid formulations into gelatin and non-gelatin capsules, Effective utilisation of lipid-based systems to enhance the delivery of poorly soluble drugs: physicochemical, biopharmaceutical and product development considerations, AAPS Workshop, Bethesda, 2007.

3. Rowley G, Filling of liquids and semi-solids into hard two-piece capsules, Pharmaceutical capsules, F Podczeck and BE Jones (eds), Pharmaceutical Press, London, 2nd edition, 9: pp 169-194, 2004 4.Brox W, Zande H, Meinzer A. Soft gelatin capsule manufacture.

EP 1993: 0 649- 651.

5. Cade et al., Liquid filled and sealed hard gelatin capsules, Acta Pharm Technol 33 (2), 1987, 97-100.

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New Bosch processing system for flexible production of injection solutions Seamless connection with ALF 5000 filling and closing machine for vials and ampoules ensures rapid processing AT ACHEMA 2018, Bosch presented its new flexible processing system for an economic production of injection solutions. Above all, the system is characterised by its modular design.

“Depending on customer preferences, the design allows the system to be expanded with additional process vessels, and modules to be flexibly exchanged,” explains Dr John Medina, Sales Director, Bosch subsidiary Pharmatec, who was involved in designing the SVP250 LF. The seamless transport of the product from the processing machine to the ALF filling machine can be tracked using a LED visualisation. Further, Bosch shows how data from the processing and filling machines is fed into a single system and visually displayed in an Industry 4.0 application.

Processing system with modular design The SVP250 LF processing system on display is designed for injection solutions (Small Volume Parenterals, SVPs) with small batches ranging from 15 to 250 litres.

The system includes both a preparation and a storage vessel. Depending on the desired volume, these process vessels can be expanded to four each, in a range of different sizes.

“Moreover, the vessel’s conical shape minimises product loss during the emptying process.

Given the costly materials the system handles, that translates into a concrete financial benefit,” says Medina The pre-configured architecture allows processing modules to be easily and flexibly installed or exchanged, for instance for different temperature-control concepts or the feeding of different media like

46 EXPRESS PHARMA April 16-30, 2018

products like suspensions can be safely transferred with minimal product loss.” The ALF 5000 continues to process the fluid immediately.

“Production on the processing system is already digitally controlled, as a higherlevel control system communicates with the preparation system and monitors the entire process,” says Medina. “The processing and filling machines exchange information through their HMIs, allowing them to coordinate each batch.” In addition, data on the machine status or powders, liquids or gases.

Liquid ingredients are automatically dosed by a pump.

Since the process vessels are equipped with a gassing module for nitrogen, production can also take place under lowoxygen conditions.

Complete separation of technical and cleanroom area The system features a module for two-stage sterile filtration for aseptic preparation, which is situated between the preparation vessel and storage vessel. It is also equipped with an optional laminar flow hood, which generates a low-turbulence air flow to prevent particles from entering the filling area. An integrated cleanroom wall completely separates the process vessels from the system’s technical area.

As a result, the cleanroom area is compact and easily accessible. Between production batches, an integrated CIP module cleans and sterilizes the system. For applications involving highly potent APIs, a containment flap is used, which also allows aseptic processing.

In line: Communication between processing and filling machines As a special highlight, visitors to the trade fair can expect to see a sample line configuration consisting of an SVP preparation system and ALF 5000 filling and closing machine. “The liquid product is directly transported from the storage tank to the filling machine,” says Medina. “We have developed preconfigured concepts that ensure even special

process parameters from both systems can be recorded, stored and visualised, which leads to improved transparency in production and shorter response times. The primary goals are optimal production planning and maximum capacity utilisation.

Filling system for high process reliability In addition to its suitability for Industry 4.0 applications, the ALF 5000 filling and closing

machine delivers a high degree of process reliability and flexibility. In the combi configuration, the machine not only processes ampoules but also injection bottles. It can be equipped with all standard filling systems and four, six, eight, ten or 12 filling heads. A carrying walking beam system can be used for especially gentle handling. Here, the glass containers are lifted slightly so as to ensure they are not damaged by rubbing along the machine guides.

Without sacrificing product quality, the ALF 5000 delivers output rates of up to 600 containers per minute.

As Tobias Goettler, Product Manager, Bosch Packaging Technology, explains, “The machine can be variably integrated into existing production processes and, just like the processing system, can be flexibly adapted to meet specific customer needs.” According to Bosch’s pharmaceuticals line competence, the system can easily be combined with upstream or downstream machines.

Customers who order both their preparation and filling machines from Bosch receive a coherent overall concept and a number of further advantages: during project implementation, Bosch attends to the complete coordination of interfaces between systems, which fosters efficient planning and smooth processes. During the design phase, Bosch can already offer solutions to concerns like cross contamination and sterile connections, together with uniform documentation and system qualification.

Contact details www.boschpackaging.com

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April 16-30, 2018

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PHARMA LIFE APPOINTMENT

Milan Paleja apointed as Country President, Novartis in India Paleja is a graduate from Bombay University and holds a Cost Accountants degree from the Institute of Cost Accountants of India

M

ilan Paleja has been appointed Country President responsible for Novartis Group companies in India and Country Head Pharmaceuticals with immediate effect.

Paleja joined Sandoz India

in 1982 in the Finance function.

He has gained a wealth of experience over the years having held positions of increasing responsibility in Consumer Health, Sandoz and Pharmaceuticals, at country and regional level, in diverse geogra-

phies such as Singapore, South Africa and Switzerland. Since March 2016, he was Country President and Head Pharmaceuticals, Novartis Indonesia.

While in Indonesia, he pioneered innovative access models, turned around the business

and laid the foundation for future growth.

Paleja is a graduate from Bombay University and holds a Cost Accountants degree from the Institute of Cost Accountants of India.

EP News Bureau

RECOGNITION

NIRF ranks pharmacy institutes in 2018 Rankings were done on the basis of recommendations of a Core Committee set up by MHRD NATIONAL Institutional Ranking Framework (NIRF) recently came out with the list of top ranked institutions in 2018 in the category of pharmacy education. NIRF utilised the overall recommendations arrived at by a Core Committee set up by the

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Minister of Human Resource Development (MHRD).

They identified broad parameters for ranking various universities and institutions which covered 'Teaching, Learning and Resources,' 'Research and Professional Practices,' 'Gradu-

ation Outcomes,' 'Outreach and Inclusivity,' and 'Perception.'

The top ranked ten institutions in 2018 are: ◗ National Institute of Pharmaceutical Education and Research Mohali ◗ Jamia Hamdard

◗ Panjab University ◗ Institute of Chemical Technology ◗ Birla Institute of Technology & Science ◗ National Institute of Pharmaceutical Education and Research Hyderabad

◗ Manipal College of Pharmaceutical Sciences ◗ Bombay College of Pharmacy ◗ SVKM’s Narsee Monjee Institute of Management Studies ◗ JSS College of Pharmacy EP News Bureau

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