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ESSP EPSA Students' Science Publication Volume 6 | Edition 2 | February 2019

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Bringing pharmacy knowledge and students together


Do not miss the new issue of EPSA Newsletter Find out more:


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Table of contents 4 The role of patients’ satisfaction in shaping the community pharmacy business model 6 Automatic on-line cardiovascular risk calculator which combines dyslipidemia and inflammation

One more time student researchers from all parts of Europe decided to unite, gather their strength and share their gained scientific knowledge with one sublime aim - to improve our profession and help their colleagues around this world. If you have not met me yet, my name is Sanja Aleksić and as EPSA Science Coordinator 2018/2019 I am more than excited to present to you the 2nd Volume of EPSA Students’ Science Publication Edition 6. EPSA Students’ Science Publication is an EPSA Science Project which presents a type of scientific journal adjusted to European pharmaceutical students. It consists of research abstracts written by students prior reviewed and approved by the European Federation for Pharmaceutical Sciences (EUFEPS), an umbrella of pharmaceutical sciences in Europe, who stands on the reviewer position of the ESSP. This volume which you are holding in your hands consists of five exceptional students abstract accepted and chosen by the EUFEPS. The presented student abstracts are various and cover different aspects of pharmaceutical science which enable us to oversee the global development of the pharmaceutical profession. Reading the abstracts you will have this unique opportunity to gain more knowledge about the most desired fields of pharmacy and to breathe in the rhythm of the development of our profession. I would like to thank the European Federation For Pharmaceutical Science for all the commitment and work they have done for us as well as for provided invaluable support for the development of pharmaceutical science on the student level. Words of praise are also deserving of our marvellous PR Department, without whom all this would not be possible. In the end, I would like to say that It was a great pleasure to work with such talented and enthusiastic young scientists! Sharing our ideas, our work and knowledge, improving our profession and spreading this miraculous spirit of science is our mission and our goal. With this ESSP Volume, we made our first steps on the mystified road of pharmaceutical science on which we are going to walk into the future. Through science to the future! Let’s science!

Bringing pharmacy knowledge and students together

8 Testing a Novel Formulation of the Drug Griseofulvin Against Different Polymers; a new topical treatment for onychomycosis 10 Effect of long-term storage on disintegration and dissolution of over-encapsulated penicillin V tablets 12 In Vivo Engineered Blood Vessels for Hemodialysis Access

Dear all,

Yours in EPSA, Sanja Aleksič Science Coordinator 2018/2019


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Automatic on-line cardiovascular risk calculator which combines dyslipidemia and inflammation Anđela Šaponjić1, Jelena Kotur-Stevuljević1, Mia Pecelj2, Đorđe Starčević2, Jelena Vekić1, Nataša Bogavac-Stanojević1 1Faculty of Pharmacy, University of Belgrade, Department for Medical Biochemistry, 2Faculty of Organizational Sciences, University of Belgrade, Information Systems and Technologies Study Program (a.saponjic1503@gmail.com)

Introduction: Cardiovascular disease (CVD) is the most frequent disease in the population older than 60 years. CVD could be diagnosed as coronary heart disease, cerebrovascular disease, peripheral artery disease and aortic atherosclerosis with a possible aneurysm. CVD are the leading cause of mortality worldwide. Dyslipidemia is one of the established, traditional cardiovascular risk factors i.e. low HDL-cholesterol (HDL-c), high LDL-cholesterol (LDL-c) and high triglycerides (TG) concentration. One of the emerging, new risk factors recognized in the last decade was inflammation. Regarding cardiovascular disease, inflammation is low-grade and chronic and could be assessed through the high sensitive C-reactive protein (hs-CRP) measurement. Aims: The aim of this study was to calculate the risk and gives feedback for every score summary cardiovascular risk evolved from calculated i.e. lipid risk score, lipid protective dyslipidemia and inflammation – DI Score score, inflammation score, dyslipidemia score (DIS) as a sum of Dyslipidemia (DS) and and DIS score. Information about risk can Inflammation scores (IS). The second aim of be “within the limits of population scores – our study was to make an automatic online without risk”, “low risk for development of calculator which could be able to calculate CVD”, “moderate risk for development of summary DIS score and to give an appropriate CVD”, “high risk for development of CVD” message about risk level, according to and “extreme risk for development of CVD”. dyslipidemia and inflammation scores values. The user has an additional option of choosing to compare current results with previous, Materials and Methods: DS is calculated and gets a message about improvement/ as a difference between lipid risk profile worsening of each mentioned scores. (average value between LDL-C z score and TG z score) and lipid protective profile (HDL-C Results: The program is intuitive and easy to z score). Inflammation score was calculated as comprehend. Its wider use could contribute a hsCRP z score. Population values needed for to better cardiovascular control as the user z scores calculation are from Serbian healthy can keep track of his/her DI scores and he/ control group values which were gathered she can react adequately if it is necessary. and analyzed for 20 years in the laboratory at the Department of Medical Biochemistry. In a Visual Studio, using programming language C we wrote a code for a program that calculates risk scores for different parameters. A user is supposed to select gender from a menu, and then inserts his/her lipid status and CRP concentrations. The program calculates


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you are working with them or you can easily make a mistake. The most important thing is to be patient, focused and to check the data from time to time to see if everything is in order.

Questions & Answers Please tell us a little bit more about yourself. Hello! My name is Anđela Šaponjić and I am currently studying at Faculty of Pharmacy – University of Belgrade. Even before my studies, I developed a passion for discovering and learning new things and so far that led me to several types of research. Aside from studying, I enjoy photography, taking part in various actions regarding public health, learning new languages, travelling and last but not least – I enjoy spending time with my friends and family. Tell us a bit more about your research and its significance. There are several important things about my research that I would like to point out. First one is that an inflammation marker was involved in the calculation of cardiovascular risk and that is very important because inflammation was recognized in the last decade as a risk factor for developing cardiovascular diseases. The second one is that we developed a first of its kind program in Serbia that combines dyslipidemia and inflammation scores in calculating cardiovascular risk. And the third one is that people while using this program can keep track of their risk and they can seek advice from their pharmacist and/or physician before diseases develop. What was the biggest challenge whilst carrying out the research and how did you overcome it? When you have a lot of data to process because there are some population values involved you need to be extra careful while

In your opinion, what is the benefit of joining ESSP and what advice do you have for students undertaking research in the future? Personally, it is an honour to have my work published in the ESSP because as colleagues, students and future pharmacists we need to share our knowledge in order to develop and become better pharmacists someday. On the other hand, as someone who was inspired several times and gained different points of view on the same problem while reading other published articles. I hope that I will manage to do that to other people! And the only advice I would like to give to other students is to never give up, there is a solution to every problem that comes up!


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Testing a Novel Formulation of the Drug Griseofulvin Against Different Polymers; a new topical treatment for onychomycosis Author: Elisavet Linardou (e.linardou@student.reading.ac.uk) Supervisor: Hisham Al-Obaidi, PhD, Lecturer Institution: School of Pharmacy, The University of Reading, Reading, U.K.

Introduction: Fungi cause nail infections termed onychomycosis by penetrating the nail plate. Systemic and topical treatments are available. The latter, known as nail lacquers, are low cost and have few side-effects but also low cure rates. Griseofulvin is an antifungal agent which inhibits fungal mitosis and is used as the active pharmaceutical ingredient (API) in combination with a polymer. Polymers should be attracted to the nail keratin and provide the required viscosity for the mixture. Objective: This study aimed to formulate a novel composition of nail lacquer containing griseofulvin. The film-forming properties and nail surface adhesion of different polymers were tested in order to create the new formulation.

acrylic polymer slides to simulate the nail bed. Three photos of plain acrylic slides were taken with a microscope and compared against 3 acrylic slides with one drop of our novel formulation and 3 slides with one drop of the novel formulation mixed with sodium bicarbonate. Penetrance was measured with Material and methods: Griseofulvin observational techniques assessing the colour (GF), Ethanol, Tartaric acid (TA) formed and evolution of the acrylic fibres of the slides. the base solution. The polymers were HPMC (Hydroxypropylmethylcellulose), Results: Both solutions affected the colour PVP(Polyvinylpyrrolidone)-k30, PVP-k90. and fibres of the acrylic slides suggesting Initially, the solubility of GF in ethanol and penetration. No significant difference was TA in ethanol was investigated by separately noted with the addition of sodium bicarbonate testing how much GF and TA can be added in our novel formulation. to 5 ml of ethanol solution until it becomes saturated. To identify an appropriate polymer Conclusion: Our results suggest that the for the formulation, we individually tested the novel formulation can potentially penetrate solubility of HPMC, PVP-k30 and PVP-k90 in the nail plate and reach the site of infection 5 ml ethanol. For each polymer 4 solutions of in cases of onychomycosis. Further research different strengths were tested. PVP-k90 had needs to be done to test the efficacy against the desired viscosity and it was chosen as fungi and the clinical effect on real infected the preferred polymer. Then, it was tested at nails. 3 different concentrations against a constant GF and TA Ethanol containing the solution. The solution with the desired viscosity and adhesion properties was chosen as the novel formulation. Sodium bicarbonate in water reacts with TA and pushes’ the medication to the infected area under the nail. We used


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Questions & Answers Please, tell us a little bit more about yourself. I am a second-year pharmacy student at the University of Reading. I was born and raised in Greece and I moved to the UK to pursue my degree. Since I was always enthusiastic about medicinal chemistry, after graduation, I aspire to work as a researcher in this field. In addition, I am a member of the university’s volleyball team and in my free time, I enjoy reading books, drawing and cooking. Tell us a bit more about your research and its significance. Onychomycosis affects a great percentage of the world’s population. The UK drug market lacked efficient nail lacquers treating onychomycosis and so we took the opportunity to research a novel formulation. Griseofulvin is a well-known anti-fungal agent and we decided to investigate its efficiency in a nail-lacquer composition. What was the biggest challenge whilst carrying out the research and how did you overcome that? I conducted this research after I had finished the first year of Pharmacy school and this itself posed a challenge for me as I was not as experienced as the other mature students would be, however, the fact that my supervisor Dr Hisham Al-Obaidi chose me to do this research project helped me overcome my initial fears and enabled me to feel confident about my skills and my abilities.

In your opinion, what is the benefit of joining ESSP and what advice do you have for students undertaking research in the future? The ESSP is crucial in developing the professionalisation of pharmacy students. It familiarises young researchers with the process of research publication. More specifically, the students will gain skills such as learning how to write a scientific abstract, accept and eventually incorporate the review by the EUFEPS. My piece of advice to students is that progress happens out of your comfort zone!


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Effect of long-term storage on disintegration and dissolution of over-encapsulated penicillin V tablets Authors: Joseph Saleh (josephsaleh@rcsi.ie), Dr Sam Maher, Dr Abel Wakai, Mr John C. Hayden Institution: Department of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland

Introduction: Over-encapsulation is the method of concealing the identity of a tablet for blinding in clinical trials. Clinical investigators are required by the EMA to show that overencapsulation does not alter drug release during storage.

Aim: The project’s aim was to determine if the release of an over-encapsulated tablet (OET) of penicillin V is affected by long term storage (12 months) and accelerated storage conditions. The goal was to determine the necessity to perform formal release testing on OETs or whether empirical data in regulatory submissions can be substituted with a written technical justification with supporting literature – thus reducing regulatory burden.

50% at 15 minutes, and >90% at 30 minutes. There was a complete release of penicillin V from both unmodified tablets and OET stored for 12 months. Interestingly, penicillin release was slower from unmodified tablets compared to OET at 15 minutes. Disintegration times for both unmodified tablets and OET were acceptable for compendial standards at 5 and 11 minutes respectively.

Conclusion: Penicillin V release from unmodified tablets and OET under accelerated storage conditions was not significantly affected according to regulatory specification. The release was more gradual from Time 0, 1, and 2 OET compared to OET stored for 12 months. However, compendial release specification was met for both formulations. It is possible that, under certain conditions, the slight difference in release results in a lag-time to the onset of action. This study shows, for the first time, that inappropriate selection of high viscosity backfill (HPMC) impedes the optimal release of penicillin V from an overencapsulated formulation, highlighting the critical pharmacologic parameter of backfill Results: There was 60-90% release of selection. penicillin V during dissolution testing between 5-15 minutes from Time 0, 1, and 2 unmodified tablets stored under accelerated conditions. There was a lag in release between unmodified tablets and OET. Release from Time 0, 1, and 2 OET was nominal at 0 and 5 minutes, 30Methods: Penicillin V tablets were overencapsulated in hard gelatin capsules with a set quantity of backfill (talc powder). Batches of unmodified tablets (positive control) and OET (modified tablets) were stored for 0, 1, 2, 3, and 6 months (Time 0, 1, 2, 3, 6) at accelerated storage conditions (40 ± 2°C, relative humidity: 75 ± 5%), or for 0 and 12 months in ambient storage conditions. Disintegration and dissolution testing was performed according to the European Pharmacopoeia. OET modified with hydroxypropyl methylcellulose (HPMC) backfill were used as a negative control.


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Questions & Answers Please tell us a little bit more about yourself. Hello, my name is Joseph Saleh and I’m a 4th Year Pharmacy Student in the Royal College of Surgeons in Ireland. I have a keen interest in research and have conducted projects both Nationally and Internationally. After I graduate and receive my MPharm qualification, I would like to pursue a PhD as I find research an essential cornerstone to any Pharmacist’s career and I believe a PhD studies would enable broader understanding of the importance of this. Tell us a bit more about your research and its significance. The essence of my project is core to Pharmacy and the care therein as it relates to the fundamental science of the formulation of medication. It primarily deals with pharmaceutics and how manipulation of a formulation can alter release profiles of medications and the significance of this phenomena. The holistic aspect of this is the potential to influence regulatory affairs in how they will deem the need for formal release profiles when altering the formulation of medication through over-encapsulation. What was the biggest challenge whilst carrying out the research and how did you overcome that? The challenges throughout the project were minimal due to the excellent support of those involved however making the sample batches were challenging due to the number of overencapsulated tablets required and accuracy thereof.

In your opinion, what is the benefit of joining ESSP and what advice do you have for students undertaking research in the future? Joining ESSP is an excellent opportunity for any European Pharmacy student to kickstart their interest in research and gain visibility from a wider audience in the research that they have conducted. I would encourage any Pharmacy student to be mindful of potential research opportunities as there are many at an Undergraduate level that give greater scope into the importance of Pharmaceutical Science and what we study on a daily basis.


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In Vivo Engineered Blood Vessels for Hemodialysis Access Student: Patrick Jongeleen Institution: Leiden University Medical Center

Introduction: There is a large need for vascular grafts for revascularization procedures such as hemodialysis vascular access. In recent years, a new technology for in situ vascular tissue engineering was developed. Studies on this technology showed that, by using the subcutaneous space as a bioreactor, tissue capsules were rapidly developed with adequate mechanical strength to allow safe implantation. Tissue engineered blood vessels are free from pre-existent vascular disease. In addition, it was revealed that these tissue capsules differentiated towards a vascular phenotype after implantation in the vasculature. Aim: This study aims to prepare a clinical trial and to compare the burst strength results of two burst strength tests, the pressurised burst strength test and the probe burst strength test. The objective is to deliver a standard research file and to assess if the probe burst strength test provides results that are as reliable as the pressurised burst strength test. Material and Methods: This study explains the process of writing the necessary documents for the standard research file and the mechanical characterisation assessment of the burst strength. The pressurised burst strength test, which fills the sample with a constant volume directly with fluid until it bursts, was the first test to perform. Then, the probe burst strength test, where a cylindrical probe is traversed at a constant speed through the sample until it ruptures, was performed using a single-column force tester. The used samples were blood vessels of bovine origin and tissue capsules, grown in the subcutis of the belly, of caprine origin. Results For the pressurised burst strength test, 16 bovine samples and 4 caprine samples, were tested with respectively a burst strength of 614.07 ± 74.88 mmHg and 1635.1 ± 369.84 mmHg. For the probe burst strength test, 19 bovine samples with 61 segments and 4 caprine samples with 7 segments were tested with respectively a burst strength of 2696.25 ± 134.47 mmHg and 2322.75 ± 341.93 mmHg from a conversion using a

surface area of 100 mm2; and, 1901.76 ± 94.85 mmHg and 1638.31 ± 241.18 mmHg from a used surface area of 142 mm2. After histological analysis of a bovine blood vessel, it was found that the tunica media is smaller in relation to the lumen, so it can be concluded that the used blood vessels were internal jugular veins. A linear regression model was fitted to analyse correlation. An R-squared value of 15.7% was found for the bovine samples and for the caprine samples an R-squared value of 34.6% was found. This means that only a small part of the variation is explained by the correlation curves of the burst strength tests. Conclusion: In this report, no significant correlation between the pressurised burst strength test method in comparison with the probe burst strength test method was found. Further research with more tantamount samples is required to draw definite conclusions. Keywords: Tissue-engineered blood vessel; In situ engineered blood vessel; Burst pressure; Pressurised burst strength; Probe burst strength; Mechanical properties.


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Questions & Answers Please, tell us a little bit more about yourself. My name is Patrick Jongeleen, 25-years old, and I graduated with an MSc in BioPharmaceutical Sciences, from Leiden, the Netherlands, this January with extensive experience in youth and students’ organisations at national and European level. I am self-motivated, eager to learn and I possess strong communication and networking skills. I use to work in multicultural teams. Currently, I’m looking to start my career in the pharmaceutical industry in which I can foster the knowledge gained during my student years. Furthermore, I have been a Senior Lifeguard during the summer period on the sunny beaches of Holland. Tell us a bit more about your research and its significance. Patients with cardiovascular diseases frequently require surgical interventions to replace their diseased blood vessels. The outcome of these interventions is poor, especially when synthetic vascular grafts are used. Tissue engineered blood vessels (TEBV) could offer a suitable alternative whereas they circumvent the fundamental limitations of synthetic grafts. In recent years, a novel technology for in situ vascular tissue engineering was developed at the LUMC. The rationale for this approach of vascular tissue engineering stems from the observation that implantation of prosthetic materials in the body initiates a foreign body response that rapidly culminates in the formation of an autologous tissue capsule (TC). After extrusion of the prosthetic material, the TC is grafted into the vasculature

whereupon it differentiates towards a blood vessel. Studies have been performed in rats and pigs to evaluate the potential of this technology to blood vessels. These proof-of-concept studies revealed that these TCs differentiated towards a vascular phenotype after implantation in the vasculature. The aim of the project was to prepare a clinical trial in which this technology is validated in humans. The main objective for the first clinical trial is to assess whether similar TCs can be grown in the subcutis in humans, with an adequate cellular and extracellular composition and sufficient mechanical properties (burst pressure, suture retention strength). What was the biggest challenge whilst carrying out the research and how did you overcome that? The outcome parameters were morphometry, immunohistochemistry, and the mechanical assessment of the burst pressure, suture retention strength, and compliance. These are mainly medical terms, so it was a challenge to become familiar in the medical world. I overcame the terminology struggles by talking to as many medical staff as possible to practice with the terms and its (sub-) parameters. In your opinion, what is the benefit of joining ESSP and what advice do you have for students undertaking research in the future? This research is fairly different than the traditional studies published in the ESSP. I would like to share that the opportunities for doing an internship are broader than only presented by the university. If you’re able to justify your choice or preference then you’ll be able to reach further than the traditional paths.


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The role of patients’ satisfaction in shaping the community pharmacy business model Machado Adriana1* (adriana.f.m.carreira@gmail.com), Silva Esperança**, Caramona Margarida1 1Pharmacy, Faculty of Pharmacy of University of Coimbra, Coimbra, Portugal **Community Pharmacist

INTRODUCTION: The assessment of patients’ satisfaction with counselling and pharmaceutical care services is an important parameter for assessing the quality of the pharmacy’s services and improving the pharmacy business model and customer loyalty. This allows the development of a new pharmacy model making use of business intelligence and the Kaizen ideology as powerful tools to manage pharmacies. AIM: The objective is to determine the role of patients’ satisfaction with the pharmaceutical services provided by the community pharmacy in shaping the business model.

CONCLUSION: Results of the present study showed the high trust of the patients in the pharmacy services and high levels of the recommendation of those services to others. This study provides baseline data for the METHODS: This anonymous pre-piloted development of a new business model for the study was conducted on patients during their pharmacy. visits to the pharmacy. The questionnaire addressed: (1) responders’ characteristics (2) the relationship between the patient and the community pharmacy from the patient’s point of view (3) the relationship between community pharmacy and patients from the pharmacy’s point of view. Descriptive statistics, factor analysis and independent sample t-tests were used for data analysis. RESULTS: During March 2018, 94 patients answered the questionnaire. The response rate was 66.2% with a larger number of older female than male respondents. Most patients reported high levels of satisfaction with counselling and pharmaceutical care services. The most desirable additional services (70.8% of the total of responses) are the pharmaceutical appointment and daily telephone support line.


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