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Handbook of Preformulation

Chemical, Biological, and Botanical Drugs

Second Edition

Sarfaraz K. Niazi, ph.d., si, frsb, fpams, facb

Adjunct Professor of Biopharmaceutical Sciences, University of Illinois and University of Houston Patent Agent, USPTO, Chicago, Illinois, U.S.A.

CRC Press

Taylor & Francis Group

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Boca Raton, FL 33487-2742

CRC Press is an imprint of Taylor & Francis Group, an Informa business

No claim to original U.S. Government works

Printed on acid-free paper

International Standard Book Number-13: 978-1-1382-9755-5 (Hardback)

This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint.

Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers.

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Library of Congress Cataloging‑in‑Publication Data

Names: Niazi, Sarfaraz, 1949- author.

Title: Handbook of preformulation : chemical, biological, and botanical drugs / Sarfaraz K. Niazi.

Description: Second edition. | Boca Raton, Florida : CRC Press, [2019] | Includes bibliographical references and index.

Identifiers: LCCN 2018056180| ISBN 9781138297555 (hardback : alk. paper) | ISBN 9781315099187 (ebook)

Subjects: LCSH: Pharmaceutical technology--Handbooks, manuals, etc. | Mixing--Handbooks, manuals, etc. | Drugs--Dosage forms--Handbooks, manuals, etc.

Classification: LCC RS199.F67 N53 2019 | DDC 615.1/9--dc23

LC record available at https://lccn.loc.gov/2018056180

Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com

and the CRC Press Web site at http://www.crcpress.com

To Durdana, Aliyah, Noor, and Aminah, my grand preteens

2.5.18

5.4

6.4

6.9

7.2

6.9.9

Preface to the Second Edition

The first edition of this book was published about 12 years ago; given the notable changes in science, driven by advanced instrumentation, augmented reality, and artificial intelligence, the pace of development of just about every industrial product has changed dramatically, but none has changed as much as the new drug discoveries and their development. So, a gap of decade in revising this book should be a big gap, demanding a complete updation of this book that has been a reference source for the development of scientists and teachers across the globe. While the second edition provides updated information on the science of preformulation, the fundamental principles that go in the preformulation phase of development remain the same, being dependent on the basic molecular structure. However, these discussions have also been updated, with special attention to an aspect that is rarely appreciated by the scientists—the legal framework of preformulation. The chapter on intellectual property has been updated and expanded to include the discussion of freedom to operate, to provide guidance on avoiding infringement of intellectual property rights, as the preformulation steps are taken, from the very beginning. As a patent law practitioner myself, I take these considerations seriously to help avoid costly litigation later in the development cycle that can be a very expensive setback.

I see this book as a continuation of the series of books that I have written, and they have all been published by CRC Press; the next in the sequence is the revision of my six-volume formulation book that has provided manufacturing-ready formulations for over 3000 products; and to follow that, I have written a handbook on bioequivalence testing to complete the cycle of regulatory filing for new products. Whereas the development of chemical drugs has become rather straightforward, the development of the biological drugs and the gene therapy products remains elusive. I have written several books in those fields also, and these have also been published by the CRC Press.

Preformulation studies constitute the delicate connection between the two major groups of scientists: those at the drug discovery end and those at the drug delivery end. Whereas scientific camaraderie, or perhaps stubbornness, at the two ends of new drug development has historic roots, it is the preformulation group of comrades that brings peace to the table. It is often humbling for the drug discovery group to bring out a novel molecule with a remarkable potential only to be shot down by the formulation group as a worthless exercise in taking it to a deliverable form. The preformulation group works with both ends and helps to reduce the overall cost and shrink the timeline of drug development. Whereas in some companies the dividing line between preformulation and formulation is often a gray zone, those who have understood the significance of keeping the two groups separate have reaped great rewards. This book is a practical manual for those involved in the preformulation stages of drug development, yet it would also be a good read for the drug discovery and drug development groups. The traditional scope of textbooks and manuals on this topic is expanded here to include biological drugs, particularly therapeutic proteins and botanical drugs or phytomedicines. The latter category is particularly significant, as it is fast becoming

evident that such regulatory authorities as the U.S. Food and Drug Administration and the European Medicines Evaluation Agency will start approving them in the same system of approval as is ordinarily reserved for small- and large-molecule, wellcharacterized drugs.

The goals of preformulation studies are to choose the correct form of the drug substance, evaluate its physical and chemical properties, and generate a thorough understanding of the material’s stability under the conditions that will lead to the development of a practical drug delivery system. Preformulation is a science that serves as a big umbrella for the fingerprinting of a drug substance or product, both at the early stage and at a later stage of development in pharmaceutical manufacturing. The preformulation phase is a critical learning time about candidate drugs. Typically, it begins during the lead optimization phase and continues through prenomination and into the early phases of development. Decisions made on the information generated during this phase can have a profound effect on the subsequent development of those compounds. Therefore, it is imperative that preformulation should be performed as carefully as possible to enable rational decision-making. The quantity and quality of the drugs available at this stage can affect the quantity and quality of the data generated—so can the equipment available and the expertise of the personnel conducting the investigations. In some companies, there are specialized preformulation teams, but in others, the information is generated by a number of scattered teams. Whichever way a company chooses to organize its preformulation information gathering, one of the most important practices to adopt is to keep close communication among the various groups involved.

The classic definitions and the management systems to conduct preformulation studies are discussed in the chapters; it would suffice for now to claim that there is a need to apply the most current knowledge and analytical sophistication available to deliver these goals. Over the past quarter of a century, the science of analysis and characterization has taken a giant leap and so have the options that are now available to scientists regarding the basic substances, as we enter the era of nanoparticles and intelligent delivery designs. A recent study authorized by the National Security Agency and conducted by Rand Corporation listed nano- and material science to be the leading sciences in the year 2015; this is an important indication of what is to come and that the science of drug discovery will be greatly affected by it. With new possibilities of materials and systems such as nano pumps, the evaluation of new drug entities will have to take a different perspective.

Crystalline structure studies form the core of preformulation studies, because molecules make crystals, crystals make particles, and particles make dosage forms. Novel research in crystallography of new entities involves the studies of amorphous forms to learn how local properties contribute to the chemical reactivity of these short-interacting forms. Solid solutions are better understood today, and studies on the effect of different solvents on the formation of solid solutions remain a challenging opportunity, which are made easy by computer simulation models. Predicting accurate behavior of amorphous forms will allow great opportunities in drug delivery. By understanding the effects of various cations and anions on crystal structure and properties, one can move toward the rational selection of counterions for salt formation and the design of stable salt forms. Neutral pharmaceuticals and excipients can and do form stable cocrystals. These cocrystals may possess superior physical properties, such as solubility, melting point, and compaction behavior. These studies seek to

understand the forces that promote the formation of neutral cocrystals, in particular intermolecular hydrogen bonding. There is an increasingly strong driving force to predict the properties of a drug in its solid form, and this, in turn, drives the need to predict the three-dimensional structure. It is important to compute all reasonable lowenergy conformers from a known chemical structure and place these conformers into ranked three-dimensional crystal structures. Studies of how particle shape influences packing properties and how this affects the translational stress into strain in the tableting process are useful. By studying such material constants as friction coefficients, Young’s modulus, and viscoelasticity, one can obtain properties of the bulk powder. This then should be followed to study polydispersity (in particle size) and to validate the model with X-ray microtomography of glass powder. The controlled crystallization of organic molecules on surfaces controls the nucleation and deposition of drug crystals of chosen structure, as formed by manipulation of the substrate surface. This provides the groundwork for the development of self-assembled three-dimensional and chemical cage formulations. The idea is that by controlling the nature of the surface of the substrate, particular polymorphs may be encouraged to grow. In addition, the directing surface may prove to be a way of stabilizing more favorable, but higher-energy, polymorphs, such that solid form selection may be made on the basis of polymorph properties and not be limited to the thermodynamically most stable form. Self-assembled functional dosage forms could provide the next generation of pharmaceutical products, obviating the need for extreme conditions encountered during tableting. Areas of research include the manipulation of surfaces to allow coating and filling and the controlled crystallization and production of porous polymeric structures by using polymethyl methacrylate as a “proof of concept” polymer.

The availability of new scientific tools is not limited to the development of small molecules; large-molecule drugs, particularly therapeutic proteins, are now studied with greater accuracy than was possible when they were first approved a quarter of century ago. With almost certainty that biogeneric (or biosimilar or follow-on, depending on which side of the Atlantic you live on) products will be approved by the U.S. Food and Drug Administration, as the European Medicines Evaluation Agency is already approving them, there will be a great rush to develop tools to study the equivalence of protein products. Given the complexities involved in predicting the side effects related to three-dimensional and even four-dimensional structures, a lot of science is yet to be developed in executing the comparability protocols. The Handbook of Preformulation: Pharmaceutical, Biological, and Natural Products provides a broad discussion of testing of biological products at the preformulation level, and it is anticipated that many new techniques will become available in the near future.

Botanical drugs had long been set aside by the busy regulatory authorities, partly because of a lack of resources to monitor them and partly because they were so poorly understood that it was better to leave them alone. This is changing fast, as all regulatory authorities worldwide have announced the guidelines on the development and submission of marketing authorization applications for phytomedicines. These are likely to be treated somewhere between the small- and large-molecule categories; a detailed discussion of the new requirements for chemistry, manufacturing, and control package submission are presented in this book, with particular emphasis on the preformulation work that needs to be performed in the development of these drugs. There is a need to devote an entire volume to these studies.

Given the fast-changing backdrop in the studies that constitute preformulation, it is heartening to know that there are several excellent resources that can be tapped by scientists on a routine basis. The American Association of Pharmaceutical Scientists (www.aaps.org) offers, among many other useful sources of information, the Preformulation Focus Group, which was established in 1993 to bring together all American Association of Pharmaceutical Scientists members, with a common interest in the broad area of preformulation research. The ultimate goal of the group is to provide a forum for the exchange of ideas and development of strategies, thereby collectively improving our capabilities in this important area of research. The goals of the group are as follows:

• To provide a forum for information exchange of issues relating to solidand liquid-state characterization of chemical entities, active pharmaceutical ingredients, excipients, and early-phase development of pharmaceutical dosage forms and delivery systems

• To promote and disseminate novel scientific advances in the areas of discovery and development of drug substances and products through themed meetings and workshops in pharmaceutical technologies or pharmaceutics and drug delivery sections

• To encourage and promote joint programs with other focus groups, academia, and regulatory agencies, for example, the Food and Drug Administration, the U.S. Pharmacopeia, and other national regulatory agencies worldwide

• To participate in the portals as the focus group newsletters, student chapters, conferences, volunteer activities, and the American Association of Pharmaceutical Scientists list serve

• To support nominations of preformulation scientists for the American Association of Pharmaceutical Scientists awards

The reader is highly encouraged to join the group and benefit from a ready knowledge base, particularly as the harmonization of the international standards of the technical packages of new drug applications is achieved. Besides these discussion groups, several journals publish relevant articles on preformulation, including the following:

• American Association of Pharmaceutical Scientists www.aaps.org

• www.admet.net is a newer web portal. It aims to keep researchers and business leaders up to date on what is happening in the dynamic fields of absorption, distribution, metabolism, excretion, and toxicology. Updated on a daily basis, the unique mix of exclusive interviews, specialist supplier listings, events, news, and new products makes this a one-stop shop for essential information. For reference, there are links to research centers, journals, books, reviews, and market reports.

• www.htscreening.net is the main web information portal that aims to keep researchers and business leaders up to date on what’s happening in the dynamic field of biomolecular screening. Updated on a daily basis, the unique mix of exclusive interviews, specialist supplier listings, events, news,

and new products makes this a one-stop shop for essential information. For reference there are links to research centers, journals, books, reviews, and market reports.

• www.CombiChem.net is the main web information portal dedicated to combinatorial and medicinal chemistry. Updated on a daily basis, the unique mix of exclusive interviews, specialist supplier listings, events, news and new products makes this a one-stop shop for essential information. For reference there are links to research centers, journals, books, reviews, and market reports.

• The Drug Delivery Insight (www.espicom.com/ddi) offers a detailed review and takes the hard work out of staying in touch with the companies, products, alliances, and research activities shaping the industry.

The work of scientists has been substantially eased through the availability of search engines on the Internet. A search for “preformulation” yielded 338,000 hits in 0.39 seconds; for “pharmaceutical preformulation,” the number was 233,000; both of these are 10 times greater than when the first edition of this book was published. The problems, therefore, arise regarding how to parse the data; a lot of redundant and superfluous information is available. It is for this reason that despite the wide availability of information, knowledge must be gained from such condensed sources as this book and other books written on the subject.

Another change in this edition takes a lead on how bibliographies and references are provided. Today, references and information are widely available, so instead of listing publications of importance, I have selected a few recent publications that are presented with abstract, to add to the current knowledge on the topic; I hope that the readers will appreciate this added value to the book.

Over the past two decades, a large number of highly sophisticated laboratories have emerged that offer excellent opportunities to outsource the preformulation work. Some of these include the following:

ABC Laboratories

Advanced Chemistry Development, Inc.

Agami

Agere Pharmaceuticals Inc.

Aizant Drug Research Solutions

Ajinomoto Althea, Inc.

Alcami

Alliance Contract Pharma

AllTranz

Almac Group

AMRI

Apredica

APS Altora Pharma Solutions, LLC

Aptuit

ARDL, Inc.

Argenta Limited

Ashland Specialty Ingredients

Avacta Analytical

Avantium Technologies BV

Averica Discovery

Avomeen Analytical Services

Azopharma

Baxter Biopharma Solutions

Bilcare, Inc.

Bio-Concept Laboratories

BioDuro

BioNimbus

Biorelevant.com

BioScreen Testing Services, Inc.

Biotechnology Consulting

Biotechpharma

Blue Stream Laboratories

Camargo Pharmaceutical Services

Capsugel, now a Lonza company

Carbogen Amcis AG

Cardinal Health

Catalent Pharma Solutions

Ceutical Laboratories, Inc.

Chemic Laboratories, Inc.

Chemir Analytical Services

CMC Pharmaceuticals, Inc.

CMIC CMO USA Corp.

Comprehensive CMC Outsourcing

Cook Pharmica, LLC

Corealis Pharma, Inc.

CoreRx, Inc.

Covance, Inc.

CPL

CRID Pharma

Dalton Pharma Services

deCode Chemistry & BioStructures

Dow Development Laboratories, LLC

Dow Pharmaceutical Sciences

DPT Laboratories

Ei LLC

Emerson Resources, Inc.

Eminent Services Corporation

Enco Pharmaceutical Development, Inc. (EPDI)

Encompass Pharma

Exelead

Exemplar Pharmaceuticals

ExxPharma Therapeutics

Formatech

Formex

Fortitech

Fresenius Kabi Product Partnering

Fresenius Product Partnering

Frontage Laboratories, Inc.

Fujifilm Diosynth Biotechnologies

Fulcrum Pharma Developments

Fulcrum Pharma Developments, Inc.

Galenix Innovations

Genzyme Pharmaceuticals

Gland Pharma Limited

Glatt Pharmaceutical Services

Grifols International, S.A.

Groupe Parima, Inc.

Halo Pharmaceutical, Inc.

Hovione

HTD Biosystems Inc.

Idifarma

IDT Australia Ltd.

InSymbiosis

Integrity Bio

Intertek

iuvo BioScience

Kemwell Biopharma

KP Pharmaceutical Technology

Kumar Organic Products

Latitude Pharmaceuticals, Inc.

LyoTechnica LLC

MedPharm Ltd.

Metrics Contract Services

Micron Technologies, Inc.

Mikart, Inc.

Murty Pharmaceuticals, Inc.

Naxpar Pharma

Nerviano Medical Sciences

Neurogen

Newport Scientific, Inc.

Nitto Avecia Pharma Services

Nupharm Group

OctoPlus N.V.

Olympus Biotech Corp.

Omnia Biologics

Orbus Pharma, Inc.

Particle Sciences, Inc.

Patheon

Penn Pharma

Penn Pharmaceutical Services, Ltd.

Phares AG

Pharmaceutical Consulting Services

Pharmaceutical Development & Manufacturing Service

PharmaDirections

PharmaFab

PharmaForm

Pharmaron, Inc.

Pharmatek Laboratories, Inc.

Pharmaterials Ltd.

PharmaZell, Inc.

PharmPro (Division of Fluid Air)

Pharmquest Corp.

Pierre Fabre Medicament

Pii

Piramal Pharma Solutions

ProJect Pharmaceutics GmbH

QS Pharma

Quality Assistance SA

Quality Chemical Laboratories (QCL)

Quay Pharma

Quintiles

Quotient Bioresearch Ltd.

Ricerca Biosciences

RiconPharma LLC

Roquette

RR Regulatory Solutions

Rubicon Research Pvt. Ltd.

SBS Pharma

SeránCascade

SICOR Biotech UAB

Singota Solutions

Sirius Analytical

Soluble Therapeutics, Inc.

Stason Pharmaceuticals, Inc.

Sterling Pharmaceutical Services, LLC

Suven Life Sciences Ltd.

Sypharma Pty Ltd.

Tedor Pharma Inc.

Temmler Pharma

Tergus Pharma

TetraGenX

Triclinic Labs, LLC

University of Iowa Pharmaceuticals

UPM Pharmaceuticals, Inc.

Velesco Pharmaceutical Services

Wolfe Laboratories

WuXi AppTec

Many of these fine companies have extended their courtesy to me in providing technical information, for which I am very grateful. In the previous edition, I had provided a URL link to these companies, but I realized that you should be able to locate them by name alone, to avoid any change in the web addresses.

The organization of this book was at first difficult, as I kept sifting away those materials that would classically constitute formulation work or be more closely related to drug discovery. However, preformulation studies, slotted in between these two, must, by necessity, overlap these disciplines to some degree. Starting with an overview of the drug discovery process in the first chapter, the book takes the reader to more specific topics, including the regulatory environment and the intellectual property requirements for both understanding how it is developed and avoiding a drug infringement. Classical studies of basic property evaluation of new drug substances for the three types of products—chemical, biological, and botanicals—are presented, along with examples of the newest trends in the use of newer techniques.

In writing this book, I have benefited greatly from those who have ventured this road before me and produced great published works. I have tried to acknowledge them in bibliographies; however, it is impossible for me to fully credit these authors and quote their written works for they may be embedded in the very language of preformulation sciences. However, despite much care, it is inevitable that errors

Preface to the Second Edition

remain; these are all mine, and I would appreciate it if the reader would bring them to my attention at niazi@niazi.com, so that I may correct them in future editions of the book.

The support of the editors and publisher was exemplary, as it has been in the previous books that I wrote for CRC Press (Informa Healthcare). The continuous support and encouragement of Jessica Poile and Hilary Lafoe and many others is deeply acknowledged.

Sarfaraz K. Niazi

Other Selected Books by Author

Niazi SK. Textbook of Biopharmaceutics and Clinical Pharmacokinetics. New York: John Wiley & Sons, 1979.

Niazi SK. The Omega Connection. Westmont, IL: Esquire Press, 1982.

Niazi SK. Adsorption and Chelation Therapy. Westmont, IL: Esquire Press, 1987.

Niazi SK. Attacking the Sacred Cows: The Health Hazards of Milk. Westmont, IL: Esquire Press, 1988.

Niazi SK. Endorphins: The Body Opium. Westmont, IL: Esquire Press, 1988.

Niazi SK. Nutritional Myths: The Story No One Wants to Talk About. Westmont, IL: Esquire Press.

Niazi SK. Wellness Guide. Lahore, Pakistan: Ferozsons Publishers, 2002.

Niazi SK. Love Sonnets of Ghalib: Translations, Explication and Lexicon, Lahore, Pakistan: Ferozsons Publishers, 2002.

Niazi SK. Filing Patents Online. Boca Raton, FL: CRC Press, 2003.

Niazi SK. Pharmacokinetic and Pharmacodynamic Modeling in Early Drug Development, in Smith CG and O’Donnell JT (eds.), The Process of New Drug Discovery and Development (2nd ed.). New York: CRC Press, 2004.

Niazi SK. Handbook of Biogeneric Therapeutic Proteins: Manufacturing, Regulatory, Testing and Patent Issues. Boca Raton, FL: CRC Press, 2005.

Niazi SK. Handbook of Preformulation: Chemical, Biological and Botanical Drugs. New York: Informa Healthcare, 2006.

Niazi SK. Handbook of Bioequivalence Testing. New York: Informa Healthcare, 2007.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 1 Second Edition: Compressed Solids. New York: Informa Healthcare, 2009.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 2 Second Edition: Uncompressed Solids. New York: Informa Healthcare, 2009.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 3 Second Edition: Liquid Products. New York: Informa Healthcare, 2009.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 4 Second Edition: Semisolid Products. New York: Informa Healthcare, 2009.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 5 Second Edition: Over the Counter Products. New York: Informa Healthcare, 2009.

Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations, Volume 6 Second Edition: Sterile Products. New York: Informa Healthcare, 2009.

Niazi SK. Textbook of Biopharmaceutics and Clinical Pharmacokinetics. Hyderabad, India: The Book Syndicate, 2010.

Niazi SK. Wine of Passion: Love Poems of Ghalib. Lahore, Pakistan: Ferozsons Publishers, 2010.

Niazi SK. Disposable Bioprocessing Systems. Boca Raton, FL: CRC Press, 2012.

Niazi SK. Handbook of Bioequivalence Testing, 2nd ed. New York: Informa Healthcare, 2014.

Niazi SK. There is No Wisdom: Selected Love Poems of Bedil. Translations from Farsi D, Niazi SK and Tawoosi M. Lahore, Pakistan: Ferozsons Publishers, 2015.

Niazi SK. Wine of Love: Complete Translations of Urdu Persian Love Poems of Ghalib Lahore, Pakistan: Ferozsons Publishers, 2015.

Niazi SK. Biosimilars and Interchangeable Biologics: Tactical Elements. CRC Press, 2015.

Niazi SK. Biosimilars and Interchangeable Biologicals: Strategic Elements. CRC Press, 2017.

Niazi SK, Brown JL. Fundamentals of Modern Bioprocessing. CRC Press, 2015.

Bibliography

Anton P, Silberglitt R, Schneider R. The Global Technology Revolution: Bio/Nano/ Materials Trends and their Synergies with Information Technology by 2015, Rand Corporation 2001. Santa Monica, CA (http://www.rand.org/pubs/monograph_ reports/MR1307/index.html).

Blumenthal M, Daniel E, Farnsworth N, Riggins C. Botanical Medicine: Efficacy, Quality Assurance and Regulation. Mary Ann Liebert, 2003.

Carpenter JF, Manning MC, eds. Rational Design of Stable Protein Formulations: Theory and Practice (Pharmaceutical Biotechnology). New York: Plenum Press, 2003.

Carstensen JT. Pharmaceutical Preformulation. Boca Raton, FL: CRC Press, 1998.

Florence AT, ed. Materials Used in Pharmaceutical Formulation (Critical Reports on Applied Chemistry, Vol. 6). Blackwell Science, 1984.

Gibson M. Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. Boca Raton, FL: CRC Press, 2001.

Hovgaard SF Jr. Pharmaceutical Formulation Development of Peptides and Proteins. Boca Raton, FL: CRC Press, 1999.