Day :
- Market surveillance of industrial pharmacy, Industrial Pharmacy Management, Drug Design and Marketing, Drug Development Stages
Session Introduction
Yousef Alomi
Ministry of Health, Saudi Arabia
Title: Pharmaceutical care strategic plan with pharmaceutical companies; future vision in Saudi Arabia
Time : 11:10-11:35
Biography:
Yousef Alomi completed his studies from King Saud University with the degree of Bachelor of Pharmaceutical Sciences in the year 1992. After six-years of higher studies, he earned his Master of Clinical Pharmacy from the same University in 1998. He is an affiliated clinical instructor of Purdue University in the USA. He is adjunct Assistant Professor of King Saud University College of Pharmacy. He was a member of Pharmacy Board at Saudi Commission for Health Specialties for 1998-2002 and 2008-2012 and Head of Pharmacy Accreditation Committee in 2010-2012. He was team member of establishing 1st Pharmacy Residency Program in Saudi Arabia. In the year 2005, he obtained Board Certification of Pharmacotherapy Specialist (BCPS). He became a member of advisory board of the Arab Pharmaceutical Journal in 2010. He was Pharmacy Board Member of Saudi Commission of Health Care Specialities from 2010-2013. He had several researches in clinical Pharmacy and pharmacy practice published in ACCP and ISPOR conferences. He had several presentations in clinical pharmacy and pharmacy practice at several conferences in and outside Saudi Arabia.
Abstract:
Strategic plan of GAPC towards pharmaceutical companies was found to establish collaboration between them. There is some misuse or non-organized distribution of educational resources with unclear vision. Strategic plan of pharmaceutical care consulting of several fundamental elements, and they are not limited to Medication Safety Program including Medication errors, Adverse drug reaction, drug quality reporting system, and RIMP system. Clinical Pharmacy programs including anticoagulation program, pain management program, and pharmacy diabetes care program, etc. Pharmacy Practice program including stability of intravenous medications, pharmacy human resources with training and education, residency programs, and pharmaceutical care local or international conferences. Pharmacy research and development is another vital area for collaboration. The pharmaceutical companies need clear vision and policy with long term partnership. Pharmaceutical care and manufactures gathering may play vital role in building excellent pharmacy career pathway with targeting patient care to reach optimal drug therapy management and prevent drug related misadventures with avoiding un-necessary cost.
Mihir Raval
Saurashtra University, India
Title: Functionality Improvement of APIs: An Important Aspect in Tablet Manufacturing for Oral Targeting
Time : 11:35-12:00
Biography:
Mihir Raval is Head of Department of Pharmaceutical Sciences of Saurashtra University (Accredited Grade “A” by NAAC) at Rajkot, in the state of Gujarat (India). Apart from Pharmacy, he is heading Department of Biochemistry of the same university. He is a Dean of Pharmacy Faculty and a Senate member of the University. He is also serving as Director of Industry Institute Interaction Cell (IIIC) of the Saurashtra University. He has served as a resource person in many national level conferences. He has more than 40 publications in various reputed national and international journals to his credit. He has also worked as Production scientist in Pharma industry.
Abstract:
Most APIs are crystalline solids at room temperature and are commonly delivered as a solid oral dosage forms. The efficacy of the drug is often dependent on the physical properties of the dosage form, and it is well established that the different solid forms of the same compound have different physical and chemical properties. Flow and compatibility of particles or powder are the most important consideration in the solid dosage manufacture. Blending, transfer, storage feeding, compaction, and fluidization, all depends on good powder flow property. The properties include particle size, particle distribution, particle shape, specific surface area, true density, tensile strength, melting form, and polymorphic form. From these fundamental properties arises the other property such as solubility, dissolution rate, flowability, and compactibility. Particle engineering/design techniques are widely used in pharmaceutical industries to modify properties of pharmaceuticals. Especially, improvement in the efficiency of the manufacturing process and high degree of particle functionality can be achieved by these techniques. Improvement in the extent and rate of dissolution of poorly soluble drugs is highly desirable which can lead to an increased and more reproducible oral bioavailability and subsequently to clinically relevant dose reduction and more reliable therapy.
Subrata Ganguli
Calcutta Institute of Pharmaceutical Technology, India
Title: A review on structure-function relationship in protein degradation and its importance in pathology
Time : 12:00-12:25
Biography:
Subrata Ganguli had completed his Ph.D. from the University of Illinois at Chicago, USA after completing his education in the Indian Insitutes of Technologies. He was a recepient of the prestigious JBNSTS Undergraduate Fellowship. He had been active in theIndian Academy press and the internet media authoring on several scientific and publc issues. He has presented more than 10 papers.
Abstract:
Structure-function relationship is a key to the understanding of functioning of bioactive molecules, as well as a prerequisite for predictive analysis and design of novel molecules with desirable bioactive properties. The authors group had analysed various in silico methodologies ( Ganguli and Sharma, Computer Society of India Communication, January 2016, pp 26—28) and the use of open source software packages. Use of open source software and databases permit molecular modeling and predictive design of molecules and of the active site in the protein by homolgy. Stability of a protein molecule in vivo determines the effectiveness of its function under physilogical conditions. Pathological conditions can be traced to malfunctioning of the proteins due the alteration in primary structure by mutation or by alteration in the post-translational modifications affecting functioning of the molecule. This review catalogues few of the better studied protein structures and describe their characteristic peculiarities with the hope that one would be able to develop predictive heuristics.
Manish Sharma
Bahra University, India
Title: Newer α-acyl β-phenylpropanoic acid derivative as PPAR-α based hypolipidemic agent
Time : 12:25-12:50
Biography:
Manish Sharma completed his BPharm from Rajasthan University and Post-graduation from BITS-Pilani. He conducted his Pre-doctoral research from University of Montana and PhD from JNU, Rajasthan. He is Dean of School of Pharmaceutical Sciences, Bahra University, Solan-HP, India. He has published more than 10 papers in reputed journals and has been serving as reviewer of repute. His area of research interest is QSAR and molecular modeling studies of biologically active small molecules.
Abstract:
A comparative QSAR study through Hansch analysis on PPAR α and γ agonists was carried out on following three series: 1) 2-Alkoxydihydrocinnamates. -logEC50=2.053(±0.899)R1Vw-1.921(±0.625)R2Vw+6.476(±0.375) n=12, r=0.95, s=0.18, F=41.37, R2=0.90, R2adj=0.88, RMSE=0.38, Q2=0.81 2) Azaindole-α-alkyloxyphenylpropionic acids. -logEC50= -0.96(±0.472)RVw+0.847(±0.344)I1+0.495(±0.249)I2+6.476 n=18, r=0.94, s=0.19, F=32.58, R2=0.88, R2adj=0.85, RMSE=0.20, Q2=0.78 3) Oxime ethers of α-acyl-β-phenylpropanoic acids. -logEC50=11.344(±6.549)CMR-0.415(±0.255)CMR2-68.072(±42.133) n=15, r=0.90, s=0.26, F=24.84, R2=0.82, R2adj=0.80,RMSE=0.41, Q2=0.73 On the basis of internally and laterally validated QSAR models and results of QSAR equation on oxime ethers of α-acyl-β-phenylpropanoic acids, scaled calculated optimum molar refractivity (CMRo) value of 14.3 for molecules was required for maximum agonistic activity. Using this clue, some oxime ethers of α-acyl-β-phenylpropanoic acids were proposed which were within the probability density derived applicability domain. The structural effects of ligand binding were examined on the basis of hydrogen bond interactions and binding energies in the final complexes obtained from molecular docking simulations. Compound RM-KT-01 was found to possess optimum calculated activity, passed Lipinski’s “rule of five” for oral absorption and lacked toxicity (mutagenicity, carcinogenicity, teratogenicity and embryotoxicity predicted by PASS). The derivative was synthesized and characterized by their physicochemical data and spectral analysis (F.T.I.R, 1H N.M.R., Elemental analysis and Mass spectroscopy). The synthesized compound RM-KT-01 (1) was screened for human PPAR (hPPAR) α agonistic activity on full length PPARα receptor transfected in HepG2 cells. The in vitro PPAR α agonistic activity (EC50) of synthesized compound was reported to be 78 nM. The in vitro activity suggests relevancy of presence of phenyl carboxamide group at one end and n-butyl group attached with phenylpropanoic acid chain of oxime ether of α-acyl-β phenylpropanoic acid. The result of transactivation assay also suggests that RM-KT-01 (1) is PPAR α selective and shows no activity on PPAR γ and PPAR δ.
Yousef Alomi
Head of national drug information centre, MOH Saudi Arabia
Title: Pharmaceutical care strategic plan with pharmaceutical companies future vision in Saudi Arabia
Biography:
Dr. Alomi is a product of King Saud University confirmed with the degree of Bachelor of Pharmaceutical Sciences in the year 1992. After six-years of higher study, he earned his Master of Clinical Pharmacy from the same university in the 1998. He is an affiliated clinical instructor of Purdue University in the USA. He is adjunct assistant professor of King Saud University college of Pharmacy. Dr. Alomi was a member of Pharmacy Board at Saudi commission for health Specialties for 1998-2002 and 2008-2012 and Head of Pharmacy Accreditation committee in 2010-2012. He was team member of establishing 1st Pharmacy Residency Program in Saudi Arabia. In the year 2005 he obtained Board Certification of Pharmacotherapy Specialist (BCPS). In the year 2008, he obtained his diploma in business administration from American University in Egypt in 2007, and he obtained a Board Certification of Nutrition Support Pharmacy (BCNSP) in 2009. Dr. Alomi worked as clinical pharmacist in critical care area and nutrition support. He is He is establish and implement several programs at MOH Hospitals at first time; Clinical Pharmacy Program, Medication Safety Program, Pain Management Program, Anticoagulation Program and Pharmacy Infection Control, including 30 Adult and 20 Paediatrics Clinical Pharmacy Program; he founder of Mass Gathering Pharmaceutical Care in Saudi Arabia. He became a member of advisory board of the Arab Pharmaceutical Journal in 2010. He became as Pharmacy Board Member of Saudi Commission of Health Care Specialities2010-2013. He had several researches in clinical Pharmacy and Pharmacy practice published in ACCP and ISPOR conferences; He had several presentations in the clinical pharmacy and pharmacy practice at several conferences in and outside Saudi Arabia
Abstract:
Strategic plan of GAPC towards pharmaceutical companies was found to establish collaboration between them. There is some misuse or non-organized distribution of educational resources with unclear vision. Strategic plan of pharmaceutical care consulting of several fundamental elements, and they are not limited to Medication Safety Program including Medication errors, Adverse drug reaction, drug quality reporting system, and RIMP system. Clinical Pharmacy programs including anticoagulation program, pain management program, and pharmacy diabetes care program, etc. Pharmacy Practice program including stability of intravenous medications, pharmacy human resources with training and education, residency programs, and pharmaceutical care local or international conferences. Pharmacy research and development is another vital area for collaboration. The pharmaceutical companies need clear vision and policy with long term partnership. Pharmaceutical care and manufactures gathering may play vital role in building excellent pharmacy career pathway with targeting patient care to reach optimal drug therapy management and prevent drug related misadventures with avoiding un-necessary cost.
Raed Al Swayed
Avalon Pharma, Saudi Arabia
Title: Market access methodology in emerging markets – Strategies for pharmaceutical industry market
Biography:
Raed Al Swayed has completed his Pharmaceutical degree in 1995 from King Saud University and Post-doctoral studies from Oxford Management Centre. He is the Managing Director of the Scientific Office/Regulatory & Public Affairs for Avalon Pharma, a premier Pharmaceutical Manufacturer organization in Saudi Arabia. He has 20 years of experience in multi-national & local pharmaceutical industry.
Abstract:
Market Access is a new concept in pharmaceutical industry; pharmaceutical companies need to better incorporate payer perspectives in drug development and commercial decision making. Increasingly strict payer evidence requirements and intense competition mean companies must develop and articulate stronger payer value propositions & manage challenges such as Address payer needs in clinical development programs for new and existing drugs Identify, formulate and test value propositions that government payers and private managed care find compelling. Determine optimal price through interconnected willingness to pay/prescribe studies with payers, physicians and patients’ affordability programs. Test global and design local pricing and reimbursement strategies that maximize return on investment. Improve team’s understanding of the complex payer and market access environment and what it takes to be successful in strategy and implementation. Highlighting Market access concept in Emerging Markets & differentiate the strategies among these markets compared to Global markets, utilizing key success factors, commercial market channels differentiations, market KAM concept type & regulatory deference's in applying Market Access, pricing & commercial operations.
Mahmoud F. Elsebai
Mansoura University, Egypt
Title: Potent and Broad Spectrum Medicinal Drugs against all Genotypes of Hepatitis C Virus (HCV)
Biography:
Mahmoud F. Elsebai is the professor at Mansoura University, Egypt
Abstract:
As many as 200 million people worldwide are infected with hepatitis C virus (HCV). About 3–4 million people are infected per year, and more than 350,000 people die yearly from hepatitis C-related diseases (Menzel et al. 2012), (WHO, June 2011). The Egyptian community is suffering from the prevalence of HCV infections (El-Fakharany et al. 2013). Even in the advanced countries hepatitis C is common and there is no any exclusive cure for hepatitis C either naturally or synthetically. HCV is the most common chronic blood-borne infection and it is the most frequent indication for liver transplantation (Haid et al. 2012). In the United States, hepatitis C is the most common chronic blood-borne infection (http://www.cdc.gov/hepatitis/HCV/ index.htm). The infection with HCV is often asymptomatic but chronic infection leads to liver cirrhosis which usually develops into liver failure, liver cancer or life-threatening esophageal and gastric varices. The diseased-liver person usually undergoes subsequent psychological disorders due to the stress of disease which complicates the illness (Takebe et al. 2013). There is no preventive vaccine available for HCV due to its highly mutable nature evidenced by the presence of more than 50 subtypes of HCV; in addition HCV infects only humans and chimpanzees (Houghton 2009). Fortunately, Dorner et al (Dorner et al. 2013) recently, were able to complete the entire HCV life cycle in genetically humanized transgenic mice with stably expressing human CD81 and OCLN and blunting the antiviral immunity in this mice infected with HCV. The standard therapy pegylated interferon plus ribavirin is only effective in 50–60% of patients and is associated with serious side-effects, and half of those which respond relapse after cessation of interferon treatment. HCV treatment(s) have changed dramatically in the era of Direct-Acting Antivirals (DAAs). Currently approved DAAs include NS3/4A protease inhibitors (telaprevir, boceprevir and simeprevir), NS5A inhibitors (daclatasvir and ledipasvir) and the NS5B polymerase inhibitor sofosbuvir. Although these drugs are showing significantly improved efficacy, treatment with these compounds showed rapid emergence of drug resistant mutants are likely to occur and spread between individuals, highly expensive, and narrow spectral activity towards different genotypes of HCV (Berger et al. 2014; Miura et al. 2014; Farnik & Zeuzem 2012). Therefore, therapeutic alternatives are of major importance and hence there is a continued interest in developing further antiviral drugs with altered mechanisms of action and low production costs. In the present study, through joint work with Spanish and Finnish teams, the water extract of the leaves of the wild Egyptian artichoke (WEA) (Cynara cardunculus L. var. sylvestris (Lam.) Fiori) showed improvement of HCV infection symptoms. Therefore, our study was divided into two main strategies: 1) The clinical investigation of WEA extract on some HCV-infected Egyptian patients (approved by the Ethical Committee of Research at the Faculty of Pharmacy, Mansoura University, Egypt, code number 2014/71). The results showed outstanding activity against HCV and its complications such as ascites and jaundice by measuring the PCR, and liver functions such as ALT, AST. 2) The phytochemistry of the WEA extract and its subsequent evaluation of inhibition capacity in vitro using cell-culture derived HCV: The chemical investigation of the WEA extract resulted in the identification of six compounds: a new sesquiterpene lactone (1), in addition to the known compounds (2-6). Their structural elucidation was done by extensive spectroscopic tools such as NMR and HR-MS spectroscopy. The absolute configuration was determined by TDDFT ECD calculations and comparison with the experimental CD spectra. Compounds 1 and 2 were the most potent among the six by using a luciferase-carrying reporter virus (Koutsoudakis et al. 2006). Time-of-addition experiments revealed that compounds 1 and 2 inhibit HCV virus at a time-point during entry. Furthermore, compounds 1 and 2, apart from cell-free infection inhibited HCV cell-cell transmission. Finally, the results showed that
- Drug Discovery and Drug Development, Healthcare pharmacy, Clinical Studies, Waste management of industrial pharmacy, Good manufacturing practices
Session Introduction
William Jesse
Cleveland Clinic, Abu Dhabi
Title: Improving care across the pharmacy spectrum: Impacting all levels of pharmaceutical excellence through self improvement
Time : 15:50-16:15
Biography:
William Jesse is a Senior Pharmacist in the Ambulatory Pharmacy at Cleveland Clinic, Abu Dhabi, and part of a team of pharmacists, technicians and distribution agents who work tirelessly to provide excellent pharmaceutical care for the patients of Cleveland Clinic Abu Dhabi. Together the Ambulatory Pharmacy team at Cleveland Clinic Abu Dhabi strives to improve the patient experience as our patients transition from clinical care in the doctor’s office to their homes with comprehensive services in counseling, allergy and drug interaction monitoring, and striving to minimize poly-pharmacy as much as possible.
Abstract:
Improving the care provided at different levels of the pharmaceutical spectrum is a difficult task. The only way to affect real change in the current business environment is to dramatically alter your approach towards excellence on a personal and professional level. This workshop-like presentation will introduce you to new concepts and ideas for taking steps to improve the landscape of your business. Industry, community, hospital or sales, the only way to make your work better is to understand the why and the how of what you do. Throughout this presentation, the audience will be immersed in a learn-practice-learn session seeking to enhance the take-away knowledge to be applied in the daily work life. We will look at different leadership styles, and thoughts and how they apply to pharmacy and to healthcare. We will also then examine our approach to improving customer service, whether the customer is a patient, physician, stakeholder, research team, classroom or coworkers
Hisham H A Mohammedkhair
University of Khartoum, Sudan
Title: The role of introducing new applicable method and procedure in good laboratory practice (GLP) leading to good manufacturing process (GMP)
Time : 16:15-16:40
Biography:
Hisham H A Mohammedkhair has completed his Bachelor’s degree at University of Khartoum in Sudan and graduate study of qualifying year at the Institute of the Endemic Disease - University of Khartoum. He is a laboratory manager of Almujlad Hospital attending several workshops in medical laboratory; with experience of seven years and is the member of Sudanese Inventors Union.
Abstract:
The GLP is not satisfied without methods and procedures minimizing errors and maximizing accuracy and precision. So GLP is an essential part of GMP. Here according to this article I want to explain the problems of method used in clinical laboratory and analytical chemistry when constructing calibration STD Graphs (the equation of dilution)when preparing number of points run in arithmetic progression; which include increasing error possibility and shortage of stock STD and the avoidance of these errors by introducing new method APW arithmetic progression way in calibration STD curves or Hisham’s method in calibration STD Graphs which depends on the available volume; When preparing plenty number of points run in arithmetic progression manner. Furthermore it can be used to modify sensitive device to suck solution in arithmetic progression manner depending on difference and the available volume (A.P.W sucking devices).
Israa H Al-Ani
Al-Ahliyya Amman University, Jordan
Title: Formulation of levofloxacin as orodispersible tablets using readymade excipients blend in comparison to classic formulation strategies
Time : 16:40-17:05
Biography:
Israa H Al-Ani has completed her PhD in 2007 from University of Baghdad in Pharmaceutical Sciences. Now she is working as an Assistant Professor of Pharmaceutics in Faculty of Pharmacy and Medical Science, Al-Ahliyya Amman University in Jordan. She has published papers in reputed journals both in pharmaceutical technology and drug delivery systems, and has been serving as a Reviewer for reputated Journals like "Pharmaceutical Research" and "African Journal of Pharmacy and Pharmaceutical Sciences". She has supervised Master degree students. She is a member of "The three-circles of Alemat Project" sponsered by the " Jordan Society for Scientific Research (JSSR) and USAID.
Abstract:
Readymade excipients blends are gaining wide attention in pharmaceutical industry these days especially for tablet production. An orodispersible tablet is intended to be placed in the mouth where it disperses rapidly before swallowing. The aim of this study is to compare the readymade exciepient blend designed for orodispersible tablets with the conventional method to manufacture them using levofloxacin as the active pharmaceutical ingredients. Different formulas were prepared to compare the powder characteristics and then were compressed using direct compression method. The compressed tablets were then evaluated for their physical characteristics and drug release properties. Results showed that using the readymade blend was advantageous regarding powder and tablets physical properties as well as drug release and dissolution.
- Functions of Regulatory Bodies, Veterinary Pharmaceuticals, Pharmacy from Natural products, Industrial Pharmacist Experts
Session Introduction
Mustafa Abdullah Yilmaz
Dicle University, Turkey
Title: Secondary metabolic profile of 14 Achillea species by LC-MS/MS, LC-MS IT-TOF and investigation of their biological activities
Time : 09:30-09:55
Biography:
Mustafa Abdullah Yilmaz is Assistant Professor at Dicle University, Faculty of Pharmacy, Diyarbakır, Turkey. He is also in charge of ther mass spectrometry and chromatography unit in Dicle University Science and Technology Application and Research Center (DUBTAM). His research areas are (high resolution) mass spectrometry and chromatography (LC-MS/MS, GC-MS, LC-MS IT-TOF), plant metabolomics, analytical method validation etc. He has published 10 papers in reputed journals.
Abstract:
In this study, secondary metabolic profile of ethanol extracts of 4 different Achillea species (A. Arabica, A. santalinoides, A. vermicularis) were determined using LC-MS/MS. A comprehensive LC-MS/MS method validation was developed for the qualitative and quantitative analysis of 37 phytochemicals including 15 phenolic acids, 17 flavonoids, 3 nonphenolic organic acids, 1 phenolic aldehyde and 1 penzopyrane. The analytes were quantified by a triple quadrupole mass spectrometer working in multiple reaction monitoring (MRM) mode. The fragmentation patterns of the studied compounds using ESI and collision-induced dissociation (CID) techniques are reported. The performance properties of the analytical method were determined by using standard solutions, spiked and non-spiked samples. Within the context of method validation, linearity, trueness (recovery), precision (repeatability and reproducibility, LOD and LOQ and expanded uncertainty (at 95% confidence level (k=2)) were determined. Afterwards, different parts of 4 different Achillea species were analysed and their phytochemical constituents were quantified by this method.
Reham F El-Kased
The British University, Egypt
Title: Antibacterial activity of raw honey versus simulated honey solution
Time : 09:55-10:20
Biography:
Reham F. El-Kased studied Pharmacy at Cairo University, Egypt. In her subsequent work (MSc. & PhD) at Proteome Center Rostock, Rostock University, Germany, she studied Proteomics, protein-protein interactions & epitope mapping using modern mass spectrometry techniques. In September 2013, she joined The British University in Egypt (BUE) as a Lecturer at Faculty of Pharma.
Abstract:
Raw honey and simulated honey samples were compared for their antibacterial activities against bacteria causing respiratory tract infections, namely Klebsiella pneumonia, Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosaand Streptococcus pneumonia, where over 50 million deaths worldwide are due to respiratory tract infections. The minimum inhibitory and minimum bactericidal concentrations of both samples were compared using different concentrations (25%, 75% and 100%). The maximum bacterial susceptibility was shown with the 75% raw honey sample and with the 100% simulated honey solution. This could be attributed to the high sugar content exerting high osmotic pressure in both samples. The isolated bacteria showed moderate susceptibility to 100% raw honey, while resistance appeared with 25% raw honey samples and 25% and 75% of simulated honey solutions. This indicates that the antibacterial activity of honey is due to the presence of specific antimicrobial components and not the osmotic pressure. This study shows the distinguished antibacterial activity of raw honey against the most common bacteria causing respiratory tract infections which makes it an ideal natural, non-toxic and cheap antibacterial agent which should be globalized.
Amani Mirghani Elsayed
Taif University, Saudi Arabia
Title: Development and evaluation of chitosan-based systems for oral delivery of insulin
Time : 10:40-11:05
Biography:
Amani Mirghani Elsayed has completed her PhD from University of Gezira. She worked as a Research Associate and Doctoral Candidate at Jordanian Pharmaceutical Manufacturing Company (JPM), Jordan, (2005-2009). She patented 2 oral insulin delivery systems. She is now working as an Assistant Professor of Pharmaceutical Technology and Research Scientist at Taif University, Taif, Saudi Arabia. She has many publications in reputed journals.
Abstract:
Diabetes is a metabolic disease with high prevalence worldwide. Exogenous insulin is given by parenteral route for the management of this condition. Non-invasive routes such as nasal, pulmonary and oral routes were explored to solve problems associated with injections. However, oral administration of insulin is the most convenient method of delivery and could improve disease management and reduce the long-term complications of diabetes. However, peroral delivery of peptides and proteins is challenging mainly due to large size, hydrophilicity and instability of these macromolecules. Nanoparticulate systems based on chitosan were developed by our group to deliver insulin orally. Nanoparticles and nanovesicles were prepared and dispersed in either aqueous or oily vehicles. In vitro, pharmacodynamics and pharmacokinetics studies were conducted to compare the above mentioned preparations. The most promising preparation was the one that was fabricated from chitosan, oleic acid and surfactants. This preparation decreased the blood glucose levels of the streptozotocin-diabetic rats remarkably after oral administration compared to the control group (P<0.05) and the antidiabetic activity was prolonged for many hours. The estimated pharmacological availability was 29% and the relative bioavailability was calculated to be 19.98%. The proposed absorption mechanisms for nanoparticles transport is via a special type of endocytosis i.e., clathrin mediated endocytosis and the main transport mechanism might be through lymphatic route. Promising results were obtained, when the nanoparticles were administered to human volunteers. This preparation showed considerable improvement in insulin delivery and could be considered as a platform technology for delivery of other peptides such as calcitonin
Andrzej Pilc
Institute of Pharmacology- PAS, Poland
Title: The antipsychotic activity of mGlu receptor agents, focus on novel allosteric vs. orthosteric agonists of mGlu4 receptors
Biography:
Andrzej Pilc is a Professor at Institute of Pharmacology, Polish Acad. Sci., and at Jagiellonian University
Abstract:
Modulation of the glutamatergic system via metabotropic glutamate receptors (mGlu) including mGlu5 receptor, positive allosteric modulators (PAMs) and mGlu2/3 receptor stimulators which could be a new, efficient way to achieve antipsychotic-like effects. The metabotropic glutamate 4 (mGlu4) receptor is the most studied among group III mGlu receptors. The antipsychotic activity of the non-selective orthosteric agonist of mGlu4/mGlu8 receptors, ACPT-I was demonstrated. The activity of the compound was evident in the models’ predictive of positive symptoms, moreover, it was shown that ACPT-I dose-dependently inhibited spontaneous EPSC evoked by DOI administration in rat frontal cortex. Similar results were obtained for the second orthosteric agonist of mGlu receptors, LSP1-2111. Later on it was shown that the compound also possessed activity towards negative and cognitive symptoms of schizophrenia, measured in the social interaction and novel object recognition tests. Similar results were obtained with selective mGlu4 receptor PAMs Lu AF21934 or ADX88178. These compounds showed an antipsychotic-like activity in animal models, albeit the efficacy of the former compound was stronger than that for the latter one. The actions of Lu AF21934 were robust and evident in animal models of positive, negative and cognitive symptoms. The administration of the selective 5-HT1A antagonist WAY100635 fully reversed the action of both LSP1-2111 (orthosteric agonist) and Lu AF21934 (positive allosteric modulator) in preclinical models considered as mirroring positive, negative and cognitive symptoms of schizophrenia. Simultaneously, the administration of sub-effective doses of the ligands induced clear antipsychotic-like effects not observed for each compounds separately. Therefore it can be speculated that the combined treatment based on the mGlu4-5-HT1A agonism may be regarded as a potentially effective new antipsychotic treatment.
- Drug Discovery and Drug Development
Healthcare Pharmacy
Clinical Studies
Waste managment of Industrial Pharmacy
Good Manufacturing practices
Functiona of regulatory bodies
Veterinary Pharmaceuticals
Pharmacy from natural products
Session Introduction
Amani Mirghani Elsayed
Taif University, Saudi Arabia
Title: Development and evaluation of chitosan-based systems for oral delivery of insulin
Biography:
Amani Mirghani Elsayed has completed her PhD from University of Gezira. She worked as a Research Associate and Doctoral Candidate at Jordanian Pharmaceutical Manufacturing Company (JPM), Jordan, (2005-2009). She patented 2 oral insulin delivery systems. She is now working as an Assistant Professor of Pharmaceutical Technology and Research Scientist at Taif University, Taif, Saudi Arabia. She has many publications in reputed journals.
Abstract:
Diabetes is a metabolic disease with high prevalence worldwide. Exogenous insulin is given by parenteral route for the management of this condition. Non-invasive routes such as nasal, pulmonary and oral routes were explored to solve problems associated with injections. However, oral administration of insulin is the most convenient method of delivery and could improve disease management and reduce the long-term complications of diabetes. However, peroral delivery of peptides and proteins is challenging mainly due to large size, hydrophilicity and instability of these macromolecules. Nanoparticulate systems based on chitosan were developed by our group to deliver insulin orally. Nanoparticles and nanovesicles were prepared and dispersed in either aqueous or oily vehicles. In vitro, pharmacodynamics and pharmacokinetics studies were conducted to compare the above mentioned preparations. The most promising preparation was the one that was fabricated from chitoan, oleic acid and surfactants. This preparation decreased the blood glucose levels of the streptozotocin-diabetic rats remarkably after oral administration compared to the control group (P<0.05) and the antidiabetic activity was prolonged for many hours. The estimated pharmacological availability was 29% and the relative bioavailability was calculated to be 19.98%. The proposed absorption mechanisms for nanoparticles transport is via a special type of endocytosis i.e., clathrin mediated endocytosis and the main transport mechanism might be through lymphatic route. Promising results were obtained, when the nanoparticles were administered to human volunteers. This preparation showed considerable improvement in insulin delivery and could be considered as a platform technology for delivery of other peptides such as calcitonin
Dinah Duarte
National Authority of Medicines and Health Products (INFARMED I.P.), Portugal
Title: Pediatric drug development in rare and orphan diseases
Biography:
Dinah Duarte, Pharmacist, completed her MSc in Regulatory Affairs and Evaluation of Medicinal Products (University of Lisbon). She is the Head of Scientific Evaluation Unit of the Portuguese regulatory authority for medicines and health products. She is an Assistant Professor; member of Committee for Medicinal Products for Human use at European Medicines Agency; Member of Human Scientific Committees Working Party with Healthcare Professionals Organisations; Member of the Portuguese Scientific Evaluation Board of Medicines; Member of the Coordinating Committee for the Treatment of Lysosomal Storage Disorders. She has presented more than 30 oral communications in national and international meetings and more than 50 poster presentations.
Abstract:
Learning Objectives: Discuss the strategic aspects, experiences and learnings with regard to regulatory framework for pediatric orphan drug. Share the experience from paediatric development process of medicines and review the opportunities offered by the different legislations for treatment of rare diseases; discuss the regulatory aspects that may impact approval of pediatric orphan drugs Proposal Details: Drug development is no longer possible without considering children and the orphan indication and/or rare disease pediatric setting involves unique considerations in addition to the more common challenges of clinical research and therefore poses extra challenges in conducting a research study. The medicinal products for paediatric use pose a challenge due to the heterogeneity of the considered age groups and the impossibility of extrapolating clinical results between adults and children. These difficulties could impact in children’s access to medicines innovation. European legislation in medicines has been in line with the path of the United States Food and Drug Administration with new procedures for granting marketing authorization now include accelerated and conditional approvals, leading to quicker access of new drugs to patients. In this evolving scenario, guidelines on the evaluation of medicinal products are subject to continuous revision. We intend to present the current status and forthcoming activities related to principles behind successful development of paediatric orphan drugs, focusing on development challenges and critical needs and provide information on various strategies designed to overcome these challenges. We will present recent examples of the pediatric orphan drug application process from designation to approval (orphan market exclusivity, similarity and significant benefit) and future developments such as the introduction of rare paediatric diseases designations and potential implications for orphan drugs.
Farrukh Sobia
Jazan University, KSA
Title: Plant natural products: Promising resource for future antimicrobial agents
Biography:
Farrukh Sobia has completed her Doctorate degree from J. N. Medical College, Aligarh Muslim University, Aligarh (India). She has been awarded Dr. D. S. Kothari postdoctoral fellowship by the University Grants Commission, Government of India and financial assistance to explore the antibiotic resistance problems and load in Indian bacterial population. She is now serving as an Assistant Professor (Microbiology) in Jazan University, KSA. She is also a member of Tropical Disease Unit at Jazan University. She has 22 publications in journals of international repute and has been serving as an Editorial Board Member of the journals. She has also submitted four DNA sequences in GenBank. Her bioghraphy has been selected and published in Marquis Who's Who in the World. Her field of interest and research is confined to mechanism and resistance to antimicrobial agents (more specifically beta-lactam antibiotics), plasmid-mediated drug resistance, and antimicrobial activity of indigenous plant extracts.
Abstract:
Due to increase in usage and selection pressure, bacteria have started expressing resistance to the existing antimicrobial agents. Drug-resistant bacterial infections are becoming more prevalent and it is a major health issue that we are facing today. This rise in resistance has limited our repertoire of effective antimicrobials, creating a problematic situation which has been worsening by the small number of new antibiotics introduced in recent years. Several plant-derived natural products can be a potential material that can be developed as antimicrobial agent because of its much more beneficial aspects as compared to synthetic antimicrobial chemotherapeutic drugs. Among plant-derived peptides, thionines were found to have toxic effects on different gram-positive and gram-negative pathogenic bacteria. Fabatins were proved to be effective in inhibition of E. coli and P. aeruginosa growth. Plant-derived phytoalexins, isothiocynates, allicins, anthocyanins, essential oils, tannins and terpenoids have been demonstrated to be responsible for antibacterial activity. These compounds are either bactericidal or bacteriostatic. Recently, many investigators have reported the effect of several plant-products in preventing infectious diseases also. The potent antimicrobial action of flavonoids and some phenolic acids against bacterial strains affecting respiratory and urinary tract of human. In recent years more research has been performed exploring the newer plant natural products, isolating newer and more novel substances with antimicrobial potential. However further research is required to validate their antibacterial potential on a battery of clinical and multidrug-resistant bacteria.
Mahmoud El-khateeb
East Tennessee State University, USA
Title: Pharmaceutical product development, manufacturing, & commercialization implementing quality by design
Biography:
Mahmoud El-khateeb is a Pharmaceutical Professional and Trainer with over 15 years of progressive technical, managerial, and teaching experience supporting all aspects of pharmaceutical product development for clinical and commercial use. He completed his PhD from the University of Queensland, QLD, Australia with a joint program of pharmacy school and college of biological sciences in the filed of metabolism of anti-cancer drugs. He completed his postdoctoral studies in the field of Pharmacology for the analysis and study of DNA from SUNY, the State University of New York at Stony Brook (NY). He has published and presented several peer-reviewed papers, patents and presentations
Abstract:
The quality of pharmaceutical/biopharmaceutical products has been usually controlled by the end product testing (Quality Control Release). To better control the product release and increase its scientific compliance with regulatory bodies and meet the customer needs, the concept of quality by design (QbD) becomes the new paradigm to ensure these expectations are met and to minimize the risks associated with the development process, scale-up and commercial productions. In this presentation, the speaker will discuss some critical stages in pharmaceutical industy for clarifications from a scientific/technical point of view including: The concepts to be applied in the design and development of a product and associated manufacturing processes; methods to ensure critical quality attributes, which can be accurately and reliably predicted; knowledge transfer framework to enable the organizational understanding required to drive effective risk management and decision making; systems that must exist to capture and organize knowledge from the continuous processes improvement to acheive the commercial production that meets safety and effectiveness consistently.
Biography:
Nigel Cryer holds a BSc (Hons) in Applied Chemistry, Graduate of the Royal Society of Chemstry and a chartered Chemist. He has over 30 years experience in the Pharmaceutical, Biotech and Logistics industry with leading companies such as Merck&Co, Roche, DHL (Deutsche Post) and currently VP Quality & Regulatory with NextPharma. He has held Global, regional and site leadership positions in API manufacture, research based pharmaceutical manufacture, biotech manufacture, speciality pharmaceutical manufacture, generic manufacture, contract manufacture, and also lifescience logistics. He is a subject matter expert in quality assurance including inspection management (FDA/MHRA/ANSM/Bfarm/Swiss Medic), auditing, process validation, equipment qualification, utility validation, sterility assurance, QC method validation, QC equipment qualifiction and computer validation. He is specialised in organisational assessment, company strategies, inspection readiness and in depth investigations.
Abstract:
GMP regulations and guidance often change, but the recent requirement to provide toxicological evaluations of products used in non-dedicated facilities so as to determine that the level of cross contamination minimises the potential for impact on patients, have put the pharmaceutical industry under severe pressure when companies attempt to fully comply with the guidence. As an example, companies who have made products for over 20 years in the same facility are now required to undertake extensive evaluations of these products within 12 months for medicinal products. This presentation explains the regulations and describes a criticality based and pragmatic approach to provide compliance with the regulation. How to deal with new EU requirments for setting health based exposure limits and thereby minimising cross contamination in shared facilities was described in EudraLex – “Volume 4 Good manufacturing practice (GMP) Guidelines Chapter 3 and 5â€. EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities†(EMA/CHMP/ CVMP/ SWP/169430/2012 Committee for Medicinal Products for Human Use (CHMP) Effective date 01 June 2015). When different medicinal products are produced in shared facilities, the potential for cross-contamination is a concern. Medicinal products provide a benefit to the intended patient or target animal; however as a cross contaminant, they provide no benefit to the patient or target animal and may even pose a risk. Hence, the presence of such contaminants should be managed according to the risk posed which in turn are related to levels that can be considered safe for all populations. To this end, health based limits through the derivation of a safe threshold value should be employed to identify the risks posed. The derivation of such a threshold value (e.g. permitted daily exposure (PDE) or threshold of toxicological concern (TTC)) should be the result of a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data. Deviation from the main approach highlighted in this guideline to derive such safe threshold levels could be accepted if adequately justified.
Reham F. El-Kased
The British University in Egypt, Cairo, Egypt
Title: Antibacterial activity of raw honey versus simulated honey solution
Biography:
Reham Elkased is the faculty of pharmacy at The British University in Egypt (BUE)
Abstract:
Raw honey and simulated honey samples were compared for their antibacterial activities against bacteria causing respiratory tract infections, namely Klebsiella pneumonia, Staphylococcus aureus, Streptococcus pyogenes, Pseudomonas aeruginosa and Streptococcus pneumonia, where over 50 million deaths worldwide are due to respiratory tract infections. The minimum inhibitory and minimum bactericidal concentrations of both samples were compared using different concentrations (25%, 75% and 100%). The maximum bacterial susceptibility was shown with the 75% raw honey sample and with the 100% simulated honey solution. This could be attributed to the high sugar content exerting high osmotic pressure in both samples. The isolated bacteria showed moderate susceptibility to 100% raw honey, while resistance appeared with 25% raw honey samples and 25% and 75% of simulated honey solutions. This indicates that the antibacterial activity of honey is due to the presence of specific antimicrobial components and not the osmotic pressure. This study shows the distinguished antibacterial activity of raw honey against the most common bacteria causing respiratory tract infections which makes it an ideal natural, non-toxic and cheap antibacterial agent which should be globalized
Israa H Al-Ani
Al-Ahliyya Amman University, Jordan
Title: Formulation of levofloxacin as orodispersible tablets using readymade excipients blend in comparison to classic formulation strategies
Biography:
Israa H Al-Ani has completed her PhD in 2007 from University of Baghdad in Pharmaceutical Sciences. Now she is working as an Assistant Professor of Pharmaceutics in faculty of Pharmacy and Medical Science, Al-Ahliyya Amman University in Jordan. She has published papers in reputed journals both in pharmaceutical technology and drug delivery systems, and has been serving as a Reviewer for reputated Journals like "Pharmaceutical Research" and "African Journal of Pharmacy and Pharmaceutical Sciences". She has supervised Master degree students. She is a member of "The three-circles of Alemat Project" sponsered by the " Jordan Society for Scientific Research (JSSR) and USAID.
Abstract:
Readymade excipients blends are gaining wide attention in pharmaceutical industry these days especially for tablet production. An orodispersible tablet is intended to be placed in the mouth where it disperses rapidly before swallowing. The aim of this study is to compare the readymade exciepient blend designed for orodispersible tablets with the conventional method to manufacture them using levofloxacin as the active pharmaceutical ingredients. Different formulas were prepared to compare the powder characteristics and then were compressed using direct compression method. The compressed tablets were then evaluated for their physical characteristics and drug release properties. Results showed that using the readymade blend was advantageous regarding powder and tablets physical properties as well as drug release and dissolution