Scientific Program

Conference Series Ltd invites all the participants across the globe to attend International Conference and Exhibition on Pharmaceutical Development and Technology Dubai, UAE.

Day 1 :

Conference Series PharmaTech 2017 International Conference Keynote Speaker Karen L Smith photo
Biography:

Karen L Smith joined Jazz in 2015 as Global Head R&D and CMO and is also a member of Jazz’ Executive Committee. She Chairs the R&D Development and Portfolio Committees and is accountable for the strategy and execution of all pre-clinical and clinical programs, overseeing staff in the UK, Ireland, Canada and the USA. She brings significant experience running large R&D organizations and has previously held a variety of physician executive and R&D positions in Australia, Japan, Canada, Europe and the US, working for companies including Bristol-Myers Squibb, AstraZeneca and Allergan. She has been extensively involved in launch planning/execution as well as business development, including numerous acquisitions, integrations and joint venture deals. Her experience also extends across several patent litigation proceedings. During her 20 years in industry, she has been instrumental in over 15 major drug and device product approvals in multiple therapeutic areas including cardiology, oncology, neuroscience/CNS, hematology, anti-infectives, rheumatology, dermatology, diabetes/metabolics and aesthetic medicine. She is also a published Scientist, Reviewer for several clinical journals, and has been an Advisor for various academic, government and corporate entities including the Institute of Medicine and PhRMA. Her qualifications include an MD degree in Cardiology, PhD in Molecular Genetics and Breast Cancer, an MBA, and a Master’s in Law. She has Board experience on both private and public companies as well as not-for-profits, and is currently a Board Director for Forward Pharma (NASDAQ: FWP) and on the Advisory Board for Ironman Inc.

Abstract:

Vyxeos (cytarabine:daunorubicin) liposome for injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio. Vyxeos represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to Vyxeos for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos was granted orphan drug status for the treatment of AML by the FDA and the European Commission. Vyxeos was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA. Taking two cytotoxic agents that are currently standard of care (known as 7+3) and encapsulating into a liposomal formulation produced statistically significant results with a 3.6 month improvement in favor of Vyxeos. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. This review will focus on the potential for drug liposomal encapsulation and utilizing this approach for better patient outcomes.

Conference Series PharmaTech 2017 International Conference Keynote Speaker Maha Ahmed Aboul Ela photo
Biography:

Maha Ahmed Aboul Ela has completed her PhD from Department of Pharmacognosy, Faculty of Pharmacy, University of Alexandria, Egypt in collaboration with Institute for Organic Chemistry, Technical University of Berlin, Germany. Her specialty is Phytochemistry and Phytotherapy. She has obtained a Post-doctoral fellowship from School of Pharmacy, University of London, UK. Currently she is the Head of Pharmaceutical Sciences Department, Faculty of Pharmacy, Beirut Arab University, Lebanon. She has more than 60 publications in national and international journals and conferences.

Abstract:

Various plants species are used in traditional folk medicine for their anti-diabetic, anti-oxidant effects and for certain gastric disorders. Examples of plants are salvia species, which have a reputation for memory enhancement. An infusion of the Salvia leaves is widely used as a mouthwash or gargle, for the treatment of inflammation of the mouth and throat. The leaves are used also as carminative and antispasmodic. Another example is Centaurea species that has been used in folk medicine for many purposes as diuretic, mild astringent, bitter tonic, digestive, emmenagogue and in cosmetics. Previous reports pointed out that, the activities of most of the examined plants are due to their contents of volatile oils and phenolic compounds obtained from different extracts. Accordingly, the current work comprises phytochemical study of some selected Lebanese medicinal plants to investigate their constituents and to explore the biological activities of the extracts of the chosen plants. The chemical structures of the isolated compounds, from two plants belonging to different species, were determined by application of different spectroscopic techniques. Furthermore, the volatile oil constituents of other Lebanese plants were investigated. The biological activities of plants’ extracts revealed promising results. This work represents a collection of the research activities performed at the department aiming to add more natural drug candidates, with potential biological activities, which could serve the pharmaceutical industry.

Keynote Forum

Vishal Mhatre

TATA Consultancy Services Ltd., India

Keynote: Drug regulatory affairs

Time : 11:40-12:20

Conference Series PharmaTech 2017 International Conference Keynote Speaker Vishal Mhatre photo
Biography:

Vishal Mhatre is a career oriented Pharmacist with 23 years of experience in Pharma Industry and Domain Consultant with substantial expertise in Regulatory Project Management, Strategy Development and Operations. He has knowledge and understanding of applicable pharmaceuticals, biological/biotech rules & regulations covering different types of submission procedures during Product Lifecycle Management with 19+ years of experience in Regulatory Affairs covering regulatory strategy development for Global submission, preparation of regulatory submissions and product lifecycle management across the Globe. He has demonstrated project management skills managing multiple assignments in regulatory operations involved in competency development of regulatory team through developing extensive training program covering current regulations & HA expectations on product development. Also, he is responsible for regulatory business strategy development and process improvement activities in current role.

Abstract:

Drug regulatory affairs cater by interpretation of Health Authority expectations for product development & accordingly dossier building for Regulatory Submission. Marketing Authorization granted by HA is the result of sufficient data generated to meet HA expectations considering quality, efficacy and safety aspects of drug product. This helps to market product as per target HA expectations and extends the product to international markets based on business strategy. Understanding of science behind product & developed product meeting minimum expectations of ICH standards, will ensure successful regulatory path for product registration. As we move from major markets, documentation requirements may go down as the international markets or emerging markets are more dependent on reference countries for first level evaluation. Industry is now aligning with ICH guidelines for product development which help to meet expectations of majority of the international markets or emerging markets. But it puts pressure on Pharma industry in the emerging markets to reconsider product develop strategy.

Keynote Forum

Vishal Mhatre

TATA Consultancy Services Ltd., India

Keynote: Drug regulatory affairs

Time : 11:40-12:20

Conference Series PharmaTech 2017 International Conference Keynote Speaker Vishal Mhatre photo
Biography:

Vishal Mhatre is a career oriented Pharmacist with 23 years of experience in Pharma Industry and Domain Consultant with substantial expertise in Regulatory Project Management, Strategy Development and Operations. He has knowledge and understanding of applicable pharmaceuticals, biological/biotech rules & regulations covering different types of submission procedures during Product Lifecycle Management with 19+ years of experience in Regulatory Affairs covering regulatory strategy development for Global submission, preparation of regulatory submissions and product lifecycle management across the Globe. He has demonstrated project management skills managing multiple assignments in regulatory operations involved in competency development of regulatory team through developing extensive training program covering current regulations & HA expectations on product development. Also, he is responsible for regulatory business strategy development and process improvement activities in current role.

Abstract:

Drug regulatory affairs cater by interpretation of Health Authority expectations for product development & accordingly dossier building for Regulatory Submission. Marketing Authorization granted by HA is the result of sufficient data generated to meet HA expectations considering quality, efficacy and safety aspects of drug product. This helps to market product as per target HA expectations and extends the product to international markets based on business strategy. Understanding of science behind product & developed product meeting minimum expectations of ICH standards, will ensure successful regulatory path for product registration. As we move from major markets, documentation requirements may go down as the international markets or emerging markets are more dependent on reference countries for first level evaluation. Industry is now aligning with ICH guidelines for product development which help to meet expectations of majority of the international markets or emerging markets. But it puts pressure on Pharma industry in the emerging markets to reconsider product develop strategy.

  • Pharmaceutical Technology
Speaker
Biography:

Brijesh Gupta has 26 years of experience in sales and marketing of Healthcare & Life Science products and services. He is a passionate leader with strong communication skills and a long track record of successful management, with experience & exposure inculcated strong interpersonal skills and ability to push performance improvement whilst at the same time delivering growth; ensuring clear objectives and expectations are delivered and maintained; exceptionally well organized with a track record that demonstrates self-motivation, creativity and initiatives to achieve both personal and corporate goals. He has outstanding success in building & maintaining relationships with customers, a proactive planner with dexterity in identifying & adopting emerging trends to achieve organizational objectives. Prior to joining Lonza India in 2012, he served as National Sales Manager for Life Technoogies (Thermo) & before that worked as Zonal Manager for Seimens Healthcare (Diagnostic Div).

Abstract:

Environmental monitoring programme is a critical aspect of documenting the state of control of the manufacturing facility. The environment monitoring programme is considered as an important laboratory control that provides meaningful information on the quality of aseptic processing environment. Many laboratories still use paper-based systems to schedule the sampling process and manage the collection of this environmental data. However, with such a large volume of samples to be taken, organizing, retrieving and interpreting this information can be a challenge. Paper records and worksheets must often be manually logged into spread sheets for data to be shared or analysed. Purpose-built MODATM solution can overcome many of the limitations associated with paper-based approaches. MODATM can reduce errors by guiding users through data-collection protocols, preventing process deviations and prompting users to complete missing information prior to submission in ways that paper-based approaches cannot enforce. MODATM solution can ensure laboratories comply with regulatory guidelines by recording all necessary measurements according to standard operating procedures contemporaneously with help of Field Data Capture (FDC) units. Visualization Mapping Tool enables a correlation of test results with floor plans of the facility. The MODA™ solution can seamlessly integrates with Laboratory Information Management Systems (LIMS) to bridge the communication gap between QC and production. Other QC systems such as particle counters, identification systems and CAPA can be interface with MODATM solution. By combining automated scheduling, workflows, mobile data acquisition, device integration, and advanced analytics, the MODA™ Solution delivers efficiencies across the organization.

Speaker
Biography:

M Aqil has completed his PhD from Hamdard University and Post-doctoral studies from University of Queensland, Australia. He is working as Associate Professor at Hamdard University, New Delhi. He has published more than 175 papers in reputed journals and has been serving as an Editor of Journal of Pharmacy and Bioallied Sciences since its inception.
 

Abstract:

The purpose of this study was to develop carvedilol nanostructured lipid carriers (CAR-NLCs) using stearic acid and oleic acid as lipid, and to estimate the potential as oral delivery system for poorly water soluble drug. The particle-size analysis revealed that all the developed formulations were within the nanometer range. The EE and loading were found to be between 69.45–88.56% and 9.58–12.56%, respectively. The CAR–NLCopt showed spherical morphology with smooth surface under transmission electron microscope (TEM). The crystallization of the drug in NLC was investigated by powder X-ray diffraction and differential scanning calorimetry (DSC) and revealed that the drug was in an amorphous state in the NLC matrix. The ex vivo gut permeation study showed many folds increment in the permeation of CAR-NLCs compared to carvedilol suspension (CAR-S). The oral bioavailability study of CAR was carried out using Wistar rats and relative bioavailability of CAR–NLCopt was found to be 3.95 fold increased in comparison with CAR-S. In vivo antihypertensive study in Wistar rats showed significant reduction in mean systolic BP by CAR-NLCopt vis-a`-vis CAR-S (p50.05) owing to the drug absorption through lymphatic pathways. In conclusion, the NLC formulation remarkably improved the oral bioavailability of CAR and demonstrated a promising perspective for oral delivery of poorly water-soluble drugs. The promising findings in this investigation suggest the practicability of these systems for the enhancement of bioavailability of CAR.

Speaker
Biography:

Naglaa G Shehab is an Associate Professor at the Pharmaceutical Chemistry and Natural Products Department, Dubai Pharmacy College, Dubai, UAE. She graduated from Faculty of Pharmacy, Cairo University, Egypt and received the PhD from the same college. She is a member of American Society of Pharmacognosy and Italo-Latin American Society of Ethnomedicine and serving as an Editorial Board Member in Natural Products Chemistry and Research. Also, she is a reviewer for many international journals concerning chemistry and biological activity of medicinal plants. She published at least 30 scientific papers also contributed in publication of a scientific book and her field of interest is bioactivity of medicinal plants.

Abstract:

Micromeria fruticosa (L) Druce spp. serpyllifolia is widely used in the Mediterranean regions in treatment of various inflammatory conditions and in wound healing. The purpose of this study was to investigate the constituents of the ethanolic extract of Micromeria fruticosa (L.), to evaluate the antimicrobial and the burn healing activities of the extract, its fractions and its isolated compounds and to formulate, characterize and evaluate natural burn-healing topical preparations containing the crude plant extract or the isolated compounds. The LD50 of the ethanolic extract (up to 4 g/kg) indicated its safety. The growth inhibitory activity of the ethanolic extract, and its hexane, chloroform, and n-butanol fractions as well the isolated compounds was evaluated in-vitro against a set of micro-organisms. The isolated compounds from the chloroform and n-butanol fractions were belonging to flavonoids and triterpenes. The ethanolic extract as well its fractions, hexane, chloroform and butanol exhibited variable antimicrobial activities comparable to broad spectrum antibiotic gentamycin used as control. These effects could be attributed to the isolated flavonoids and triterpenes compounds. Burn healing potentiality of the ethanolic extract was also explored against the commercial product and found noticeably significant. Histopathological analysis showed sever endodermal, columnar basal cells and sebaceous gland damage in the untreated burnt animals whereas treated animals showed significant reduction in wound size and improvement in the histological finding. Besides, from the in vivo burn healing and histological results, the topical formulae enhanced the skin wound re-epithelialization and speeded up the healing process.

Tianmin Zhu

Zhejiang Hisun pharmaceutical Co., Ltd., P R China

Title: A prodrug approach for drug delivery of everolimus
Speaker
Biography:

Tianmin Zhu, PhD, is currently working as CSO of Zhejiang Hisun Pharmaceutical Co., Ltd. In this role, he is responsible for the entire R&D with a portfolio of synthetic small molecules and fermentation natural products in oncology, cardiovascular, neuroscience and anti-infective therapeutic areas. Prior to joining Hisun, he has served as Senior Director of Pfizer’s R&D at Pearl River, New York (formerly Wyeth Research), where he held a variety of increasingly responsible research positions. He graduated from Fudan University with BS in Chemistry and MS in Organic Synthesis. Then, he joined the Shanghai Institute of Biochemistry to explore the Field of Biotechnology. After, he obtained his PhD in Analytical Chemistry from Rutgers, The State University of New Jersey, New Brunswick, he served as a Post-doctoral fellow focusing on the drug design and delivery platforms at the Center for Advanced Biotechnology and Medicine (CABM), UMDNJ-Robert Wood Johnson Medical School, and Rutgers University before joining Wyeth in 1994. He has shown leadership through his scientific accomplishments. His contributions to the marketing of several innovative medicines globally have been awarded with numerous internal and external awards. He was the winner of the Emerald Honors Award and named Senior Technology Fellow by Science Spectrum in 2005. He is the author of more 20 plus peer-viewed papers, as well as the inventor of 20 US granted patents and numerous patents worldwide. His professional interests include integrating pharmaceutical R&D into the global drug development process, especially in the emerging markets, working on the technology transfer process to manufacturing internally and externally, creating diversified intellectual property platforms for innovative medicines worldwide.

Abstract:

A novel water-soluble everolimus prodrug, glutathione-everolimus, was designed and synthesized by introducing an endogenous tripeptide with an acetyl as a linker. The improvement in water solubility allows the conjugate to be developed into an injectable drug. The results of biological evaluation in vitro and in vivo suggest that the prodrug is more effective and long acting than everolimus. Meanwhile, the pharmacokinetics study in vivo (both in mice and machine) confirmed that the delivery of everolimus through the injection of the prodrug overcome the low bioavailability of oral everolimus.

Speaker
Biography:

Dr Smith joined Jazz in 2015 as Global Head R&D and CMO and is also a member of Jazz’ Executive Committee. She Chairs the R&D Development and Portfolio Committees and is accountable for the strategy and execution of all pre-clinical and clinical programs, overseeing staff in the UK, Ireland, Canada and the USA. Dr Smith brings significant experience running large R&D organizations and has previously held a variety of physician executive and R&D positions in Australia, Japan, Canada, Europe and the U.S., working for companies including Bristol-Myers Squibb, AstraZeneca and Allergan. Dr. Smith has been extensively involved in launch planning/execution as well as business development, including numerous acquisitions, integrations and joint venture deals.  Her experience also extends across several patent litigation proceedings. During her 20 years in industry, Dr Smith has been instrumental in over 15 major drug and device product approvals in multiple therapeutic areas including cardiology, oncology, neuroscience/CNS, hematology, anti-infectives, rheumatology, dermatology, diabetes/metabolics and aesthetic medicine. Dr. Smith is also a published scientist, reviewer for several clinical journals, and has been an advisor for various academic, government and corporate entities including the Institute of Medicine and PhRMA. Dr. Smith’s qualifications include an MD degree in cardiology, PhD in molecular genetics and breast cancer, an MBA, and a Master’s in Law.  She has Board experience on both private and public companies as well as not-for-profits, and is currently a Board Director for Forward Pharma (NASDAQ: FWP) and on the Advisory Board for Ironman Inc.

Abstract:

VYXEOS (cytarabine:daunorubicin) Liposome for Injection, also known as CPX-351, is a nano-scale co-formulation of cytarabine and daunorubicin at a synergistic 5:1 molar ratio.  VYXEOS represents a novel approach to developing combinations of drugs in which molar ratios of two drugs with synergistic anti-tumor activity are encapsulated in a nano-scale liposome in order to maintain the desired ratio following administration. The FDA granted Breakthrough Therapy designation to VYXEOS for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).  VYXEOS was granted orphan drug status for the treatment of AML by the FDA and the European Commission.  VYXEOS was also granted Fast Track designation for the treatment of elderly patients with secondary AML by the FDA. Taking two cytotoxic agents that are currently standard of care (known as 7+3) and encapsulating into a liposomal formulation produced statistically significant results with a 3.6 month improvement in favor of VYXEOS.  The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3.   This review will focus on the potential for drug liposomal encapsulation and utilizing this approach for better patient outcomes. 

Marios Kyriazis

ELPIs Foundation for Indefinite Lifespans, UK

Title: The influence of the environment and drugs against the ageing process
Speaker
Biography:

In many laboratories across the world there are projects aiming to develop effective therapies against age-associated conditions. Pharmaceuticals and nutraceuticals are being evaluated and offered for consumption by the public on a regular basis. New and not-so-new compounds attract attention as possible ‘longevity elixirs’, and examples include resveratrol, metformin, mTOR modulators, calorie restriction mimetics, NAD+, carnosine, and many others. Although there is some merit in using such agents in an attempt to lessen the impact of age-associated chronic dysfunction, there is no evidence to suggest that these remedies will lead to the elimination of ageing. There are several reasons for this but an important one is that we need to evaluate such compounds not in isolation, but in relation to the human environment. This means that societal and cultural elements come into consideration, in addition to the pharmaceutical ones. Research shows that compounds may have different effects if these are evaluated in the social context of the patient, and other effects if considered in pharmacological isolation. If we want to eliminate age-associated dysfunction and achieve radical life extension, we need to move away from simple drug models and study instead complex scenarios which take into account socio-cultural and techno-cultural aspects.

Abstract:

Marios Kyriazis qualified as a medical doctor (MD) from the University of Rome, Italy, and also as a Gerontologist with interest in the biology of aging from Kings College London. He is a Chartered Member of the academic organisation ‘Royal Society of Biology’ in the UK. He also has a post-graduate qualification in Geriatric Medicine from the Royal College of Physicians of London. Other appointments include Member of the Board of Trustees at the Mediterranean Graduate School of Applied Social Cognition, affiliate researcher at the Evolution, Complexity and Cognition Group, University of Brussels, and a Ronin Research Scholar. He has a portfolio of over 1000 articles, papers and lectures on ageing both for academics and the public.

Speaker
Biography:

Dr. Mohamed Ismail Nounou serves the College as an Assistant Professor of Pharmaceutical Sciences. He joined Appalachian College of Pharmacy in January 2016. Dr. Nounou is a professional pharmaceutical formulator and a medicinal chemist. Dr. Nounou began his research career at Alexandria University in Egypt in 2001 where he worked as a full time researcher from 2001 until 2006. He obtained his Bachelor of Pharmacy (2001) as well as Master’s Degree in Pharmaceutical Sciences (2005) from Alexandria University, Egypt. Dr. Nounou received his Ph.D. in Pharmaceutical Sciences from the University of Houston in December 2011. The main focus of his Doctorate Degree research was the design and formulation of novel bioreducible polymeric non-viral gene delivery systems. Immediately after he has earned his Ph.D., Dr. Nounou worked as a Research Associate at Texas Tech. University (Health Sciences Center) on December 2011.

Abstract:

Observing the research and development for novel and innovative drug carrier systems in the past fifteen years has been thrilling and exciting. The research trend moving from prodrug technologies based on minimal chemical modifications to comply to Lipiniski rule of five (Drugs Ver 1.0), to novel nanocarriers such as nanoparticles, nanoemulsaions, vesicular systems and polymeric and peptidomemetic systems (Drugs Ver 2.0) to finally novel bioresponsive smart bioconjugates (Drugs Ver 3.0). This review would focus on novel smart bioconjugates, current innovations in its design language, advantages, industrialization, scaling-up, current patent status and its transformation from bench (Lab. small scale production) to bedside (industrial manufacturing stage). Finally, this review will focus on the role of pharmaceutical formulators in transitioning novel bioconjugates from synthetic chemical compounds to final dosage forms, overcoming the hurdles of synthesis reproducibility and purity of the final bioconjugates and the associated adjuvants used in the chemical synthesis. Innovative and updated strategies in formulation design and development are required to take bioconjugate systems efficiently from bench to bedside.

Speaker
Biography:

Stojan Rendevski has completed his PhD at the age of 35 years from University “Ss. Cyril and Methodius”, Skopje, Republic of Macedonia. His research field is Soft Matter Physics and Food Physics. He has published more than 40 papers in reputed journals and has managed two international projects and has been principle investigator in one NATO science project related to development of new technology for hydrogel particles preparation. In Macedonia, he established undegraduate studies of Optometry and postgraduate studies of Soft Matter Physics and also has been a Dean of Faculty of Electrical Engineering. Currently, he is a Lecturer of Physics at HCT, UAE.

Abstract:

The controlled release properties of calcium alginate hydrogels are predetermined mainly by two factors: the monomer composition of the alginate (mannuronic-to-guluronic ratio) and the technology of gel preparation that lead to more or less homogenous hydrogels. The inhomogeneity of the calcium alginate hydrogels has been investigated in the respect to the size and amount of calcium alginate microgel structure existing in the sodium alginate gelling solution. Dynamic light scattering measurements and scanning electron microscopy has been utilized for characterization of the hydrogels. The controlled release properties have been found dependent on the size and amount of calcium alginate microgels in respect to changed lag-time, intensity of the burst effect, release rate and release efficiency. The findings also suggest that the mixing technique plays an importnat factor in preparation of homogen calcium alginate core hydrogels with or without a shell layer.

Speaker
Biography:

Dr. Mohamed Abbas Ibrahim is professor of Pharmaceutics, Kayyali Chair for Pharmaceutical Industries, King Saud University, KSA. He gained a Ph.D. in Pharmaceutical Technology from the University of Regensburg, Germany, in collaboration with Al-Azhar University. His Research interests include biomaterials as drug delivery systems, pelletization and tablet technology. Dr. Ibrahim has a good experience in the pharmaceutical polymers that affect drug delivery, especially those controlling the drug release from the pharmaceutical oral dosage forms. In addition, he published several international research articles in these areas.

Abstract:

The interest in pellets as dosage forms has been increasing continuously. Several therapeutic advantages could be achieved using pellets as drug delivery system, over the single-unit regimen, such as less irritation of the gastro-intestinal tract and a lowered risk of side effects due to dose dumping. It has been shown that the rheological properties of wet masses can be successfully monitored by a mixer torque rheometer. It was shown that the rheological properties of wet mass could affect the release patterns from pellet formulations.

Different authors utilized pellets and granules controlled drug delivery systems techniques, which do not involve using organic solvents or coating, due to stringent global requirements of product safety. By developing matrix sustained release system one predominantly save time and money by omitting the coating operation. Monitoring the coating process by determining the amount of drug or color deposited is tedious, and often, encountering large variability. In addition, several attempts have been made to modify drug release from multi-particulate oral dosage forms by incorporating various hydrophobic materials into a basic formulation for pellets. Such systems retard the penetration of aqueous fluids into the formulation and hence slow the rate of drug release.

On the other hand, hydrophilic excipients can be incorporated to the pellets' wet mass so as to enhance the drug dissolution, giving advantages in addition to lowering the drug GI irritation and presenting homogenous drug absorption.

Rashid Mahmood

Surge Laboratories Private Limited, Pakistan

Title: Hot melt extrusion: An emerging drug delivery technology
Speaker
Biography:

Rashid Mahmood has Master Degree in Analytical Chemistry and MS in Total Quality Management. He has 13 years of experience of Pharmaceutical Quality Operations and has attended many international conferences as a keynote speaker. He has presented various talks in USA & China on Cleaning Validation, cGMP Guidelines and Quality Risk Management. Currently he is working as a Senior Executive Manager Quality Operations for Surge Lab.(Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company in Pakistan.

Abstract:

Over the last three decades hot-melt extrusion (HME) has emerged as an influential processing technology in developing molecular dispersions of active pharmaceutical ingredients (APIs) into polymers matrices and has already been demonstrated to provide time controlled, modified, extended and targeted drug delivery resulting in improved bioavailability. HME has now provided opportunity for use of materials in order to mask the bitter taste of active substances. Since industrial application of the extrusion process back in the 1930’s HME has received consider able attention from both the pharmaceutical industry and academia in a range of applications for pharmaceutical dosage forms, such as tablets, capsules, films and implants for drug delivery through oral, transdermal and transmucosal routes. This makes HME an excellent alternative to other conventionally available techniques such as roll spinning and spray drying. In addition to being a proven manufacturing process, HME meets the goal of the US Food and Drug Administration's (FDA) process analytical technology (PAT) scheme for designing, analyzing as well as controlling the manufacturing process through quality control measurements during active extrusion process.

The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. . HME involves the application of heat, pressure and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability

Speaker
Biography:

Dr Punniyakoti Veeraveedu Thanikachalam obtained PhD from Niigata University of Pharmacy and Applied Life Sciences, Niigata. Japan. He is a recipient of prestigious JSPS scholarship for postdoctoral studies in Osaka University Japan. He has published more than 50 papers in ISI journals with cumulative impact factor of 165.  His particular area of interest in research is to discover novel molecules for the treatment of cardiovascular diseases. At present, he is associated with International Medical University, Kuala Lumpur, Malaysia. 

Abstract:

Background: High levels of cortisol in humans cause metabolic abnormalities such as insulin resistance, dyslipidaemia etc. which may lead to diabetic cardiomyopathy (DCM) in type 2 diabetes mellitus (T2DM). 11beta-hydroxysteroid dehydrogenase type 1 (11β-HSD1) is an enzyme which is responsible for conversion  of cortisone to cortisol. Therefore, selective inhibition of 11β-HSD1 activity could offer a new approach to treat complications of T2DM.

Objective: To evaluate the efficacy of selective 11β-HSD1 inhibitor (TR-013A) in attenuating DCM in type 2 diabetic mice.

Methodology:

DCM was elicited in C57BL/6J mice by feeding them with high fat diet (HFD) and intraperitoneal injection of streptozotocin at a dose of 75 mg/Kg body weight once a day for three days.  Mice received only chow diet served as normal control (Group I). The diabetic mice were randomly divided into three groups. Diabetic control (Group II) received vehicle (1% CMC p.o.); treatment (Group III) received TR-013A (30mg/kg bid, p.o) and standard (Groupd IV) receieved (RU38486 10mg/kg bid, p.o) for 21 days. Blood glucose was monitored at specific time interval during the study period.

Result and discussion: TR-013A has significantly lowered plasma glucose level, lipid parameters compared to the diabetic control group. The plasma glucose lowering effect was comparable to that of RU38486. Furthermore, cardiac remodeling events such as inflammation, fibrosis, hypertrophy and oxidative stress were reversed by both TR-013A and RU38486 in comparison to diabetic control. Interestingly, the mice did not gain weight upon treatment with TR-013A.

Conclusion: These results demonstrate that TR-013A does exhibit anti-hyperglycaemic, anti-lipidaemic, anti-hypertrophic, anti-oxidative, anti-inflammatory and anti-fibrotic activities. Thus, inhibition of 11β-HSD1 can be an attractive therapeutic target for DCM.  

Speaker
Biography:

Prof. Maha Aboul Ela has completed her PhD at Department of Pharmacognosy, Faculty of Pharmacy, University of Alexandria, Egypt in collaboration with Institute for Organic Chemistry, Technical University of Berlin, Germany. Her specialty is phytochemistry and phytotherapy. She had a postdoctoral fellow ship at School of Pharmacy, University of London, UK. Currently she is the head of pharmaceutical sciences department, Faculty of Pharmacy, Beirut Arab University, Lebanon. She has more than sixty publications in national and international journals and conferences.    

Abstract:

Various plants species are used in traditional folk medicine for their anti-diabetic, anti-oxidant effects and for certain gastric disorders. Examples of plants are salvia species, which have a reputation for memory enhancement. An infusion of the Salvia leaves is widely used as a mouthwash or gargle, for the treatment of inflammation of the mouth and throat. The leaves are used also as carminative and antispasmodic. Another example is Centaurea species that has been used in folk medicine for many purposes as diuretic, mild astringent, bitter tonic, digestive, emmenagogue and in cosmetics. Previous reports pointed out that, the activities of most of the examined plants are due to their contents of volatile oils and phenolic compounds obtained from different extracts. Accordingly, the current work comprises phytochemical study of some selected Lebanese medicinal plants to investigate their constituents and to explore the biological activities of the extracts of the chosen plants. The chemical structures of the isolated compounds, from two plants belonging to different species, were determined by application of different spectroscopic techniques. Furthermore, the volatile oil constituents of other Lebanese plants were investigated. The biological activities of plants’ extracts revealed promising results. This work represents a collection of the research activities performed at the Department aiming to add more natural drug candidates, with potential biological activities, which could serve the pharmaceutical industry.

Speaker
Biography:

Dr. Biplab Kumar Dey has completed his PhD at the age of 34 years from the University of North Bengal, Darjeeling, India on 2010. Presently he is working as the Director of Assam down town University, a premier rising organization in North East region of India. He has guided 13 Post Graduate projects and presently guiding 08 PhD scholars. He has extensively worked upon various dosage form designs and has published more than 45 research papers in various National and International Journals. He is also associated as Editor/Chief Editor with many reputed Journals and is a life member of IPA.

Abstract:

Transdermal drug delivery system is designed to transfer drugs through intact skin for systemic treatment. It offers controlled release of contained drug by a simple application to the skin's surface providing for more efficient drug utilization. In this research work, transdermal patches of Propranolol Hydrochloride were prepared as monolithic matrices by solvent casting technique. Both side opened glass moulds were wrapped with aluminium foil at one end onto which PVA backing and drug-polymer matrix were cast. Patches were formulated by using three polymers EC, PVP K30 and HPMC K4M in two combinations and in different proportions. Dibutyl phthalate (30 % w/w of polymer) and propranolol hydrochloride (20% w/w of polymer) in ethanol (10 ml) along with the polymers in requisite ratios were used to prepare the casting solution. All the prepared formulations indicated good physical stability when evaluated for thickness, weight variation, drug content, flatness, tensile strength, folding endurance, moisture content and water vapour transmission rate. Results of in-vitro permeation study revealed that the formulations prepared with least concentration of hydrophilic polymer blended with highest concentration of hydrophobic polymer (TTS6 and TDS6) have showed most extended drug release up to 48 hours through albino rat skin. It was observed that the drug release pattern was diffusion controlled when the data was fitted to various kinetic models. Result of in-vivo skin permeation study performed on male rabbit also confirmed that increase in hydrophobic polymer concentration blended with minimal hydrophilic polymer concentration have resulted in sustained release of the loaded drug from the transdermal patches.

Speaker
Biography:

Dr. Shashikant H Gaikwad  has his expertise in investigation of metal complexes in solution as an analytical methods for determination of noble metals and solid complexes for their biological activities. His team working with new compounds of biological importance for the development of new drugs.

Abstract:

The new schiff base ligands 4-(4’-nitrobenzylideneimino)-3-methyl -5-mercapto-1,2,4-triazole and their Co(II), Ni(II) and Cu(II) metal complexes were synthesized and characterized by elemental, various spectroscopic(UV-vis., IR) thermal and, magnetic moment measurements. The ligand was synthesized by condensation of 4-amino-5-mercapto-3-methyl-1,2,4-triazole with 2/3/4-nitrobenzaldehyde. On the basis of electronic spectral data and magnetic susceptibility measurements the octahedral geometry has been proposed for all the Co(II) and Ni(II)  complexes and square planer for Cu(II) complexes. The ligand and  metal complexes have been screened for their antimicrobial activities against bacteria(Staphylococcus aureus, Pseudomonas aeruginosa)and fungi(Aspergillus niger and Candida albicans). Further the material was also screened for anticancer activity on human cancer cell lines such as  breast(MCF7), lung(NCI-H226), prostate(PC-3) and  ovary(OVCAR-3) by using sulforhodamine-B(SRB).

Speaker
Biography:

M Salhab is an Academic Clinical Fellow in Orthopaedics at Leeds Musculoskeletal Biomedical Research Unit with a PhD studentship in Pharmaceutics and currently involved in developing the NM. He has published many articles in Surgical field and also Bioethics & Basic Science.

Abstract:

Background:  Acute pain control following elective primary total knee replacements (TKRs) and total hip replacements (THRs) is often poor and is associated with long term chronic pain syndrome. Moderate to severe pain is often reported in the first 48 hours following surgery requiring different pain modality management strategies such as patient controlled analgesia and multimodal drug analgesia. The Local Infiltration Anaesthetic (LIA) technique is currently an established technique to tackle perioperative pain relief; however, studies have reported conflicting evidence so far. In a recent review of 29 studies investigating the use of LIA in TKR, LIA emerged as a safe technique with improved pain control (Gibbs DMR 2012). We have developed the LIA technique to include an intra-articular catheter allowing an infusion of Novel Mixture (NM) to be infused continuously postoperatively.

Aims and Objectives: In this study we report on our experience using LIA in addition to the Novel Technique and Proprietary NM developed in Leeds-Bradford and infiltrated at 4-5 mls/hour for 48 hours post surgery.

Materials and Methods: Between October 2013 and October 2015, 62 patients undergoing primary TKR were prospectively followed up. Three groups of patients were studied. All patients studied had spinal anaesthesia (SA) with 300-400mcg diamorphine.Demographics reveal similar distribution between the two groups in terms of age and sex.

Results and complications:  The patients without LIA or NM required more morphine in the first 12 hours postoperative period than the other groups. Seventy percent (n=14) of these group 1 patients required 10mg morphine  following TKR compared to only 2% (n=1) of patients requiring 10mg of morphine when LIA and NM were used. The increased morphine requirement continued for 48 hours postoperatively in group 1, whereas none of the patients in groups 2 or 3 required morphine after 36 hours.  Statistical analysis revealed no difference of morphine requirements with different catheter placement. Fewer patients suffered from nausea and vomiting or urinary retention in the group with LIA and NM (p-value <0.05, Mann-Whitney test). There were no infections DVT or other complications in any of the groups.

Conclusion: This study demonstrates that patients following TKR treated with LIA and NM for 48 hours after required significantly less morphine during this time. This benefit was most marked in the first 24 hours after surgery and the benefit was maintained for 48hours. Fewer patients required opiate analgesia when LIA plus NM was used compared to the other groups. The highest significance was at 0-12 hrs for patients requiring up to 20mg morphine usage (χ2(2) = 46.713, p = 0.000); and 0-12hrs for patients requiring 30mg morphine usage (χ2(2) = 46.310, p = 0.000).

Speaker
Biography:

Koushik Nandan Dutta has completed his M.Pharm in 2013 from Uttarakhand technical university, Dehradun and enrolled PhD in Assam Down Town University, Guwahati, Assam.He has completed 1 year project at Defence Reserch laboratory, Tezpur Assam. Currently he is working as a Assistant Professor in the department of pharmaceutical science in Assam Down Town University. He has published twelve publication in reputed journals.

Abstract:

Mucuna pruriens (Linn) is Known as velvetbean or cowitch found in Africa, India and the Caribbean belonging to the family Fabaceae.Mucuna pruriens Linn is a herbaceous vine, generally tap rooted and reproducing by seeds, leaves have three leaflets up to 15 cm long, densely hairy beneath and rather silvery the lateral leaflets asymmetrical. Hair lining of mucuna seeds were tested for acute dermal toxicity. Hair lining were mixed with dusting powder and prepared three formulation according to concentration. This test was performed on rats based on OECD guideline number 404 (OECD, 1981a). In case of acute dermal toxicity study there was no treatment related mortality in any of the groups following topical application of formulations in either male and female rats for 14 days .Hematological Studies revealed that after application of tested formulation WBC like monocyte, neutrophil, eosinophil were increased. Serum biochemistry data did not produce significant differences between control and treated groups of both sexes in the majority of cases.In case of electrocardiography the animals showed normal value as compared to the control group. In whole body plethysmograph the treated animals showed similar value as compared to the normal group . After Sacrifice, the gross examination of the vital organs like liver, kidney and lungs, no noticeable hemorrhage and abnormal conditions were observed. The histopathological study did not showed any type of abnormality of skin in all treated group. It can be concluded from the finding of the present study that the findings of these studies support the safety use of the test substance Mucuna pruriens.

Speaker
Biography:

Dr. Isaac Karimi is an academic member in the Razi University, Iran, which he joined in 2008. He received his Doctor of Veterinary Medicine (DVM; 1998-2004) from Shahr-e-Kord University, Iran, and his Doctor of Veterinary Sciences (Ph.D.; 2004-2008) in physiology from Urmia University, Iran. He had a research visit in enzymology at Universidad Juárez Autónoma De Tabasco, México (2011). At Razi University, he established enzymology laboratory, laboratory of Molecular and Cellular Biology 1214, and behavioral neuroscience laboratory. I.K. has an interdisciplinary view, however he is concentrated on ethnopharmacology, translational research, safety pharmacology and nanotoxicology. Recently, he established the research team in computational biology and biomathematics. He supervised many theses and industrial R&D projects. He is research founder of Pars Ghousht Negin Company that produces and distributes protein products in Middle East. He received four distinguished researcher's awards from Razi University. I.K. (co-)authored over 60 research papers and book chapters and served as a senior editor or a member of editorial board of 10 peer-reviewed journals and as a reviewer of more than 20 peer-reviewed journals in the area of pharmaceutics, pharmacology, pharmacognosy, and biomedicines.

Abstract:

"All components and properties found in the greater world, the universe, will be searched and found in the lesser world, human." - AbÅ« Ḥāmid Muḥammad ibn Muḥammad al-GhazālÄ« (Algazelus), a muslim philosopher (c. 1058 – 1111).

More than two century ago, a German pharmacist Friedrich Wilhelm Adam Serturmer isolated morphine from opium poppy (Papaver somniferum L.). Afterward morphine congeners introduced into the market. After a long pause, by the 1973s, opioid receptors and endogenous opioids (endorphins) have been discovered by researchers at Johns Hopkins University. In a similar scenario, in 1964, a Bulgarian-descent Israeli organic chemist, Raphael Mechoulam, identified and synthetized Δ9-tetrahydrocannabinol, the main psychoactive principle of hashish prepared from Cannabis sativa L. and his research team also discovered the endogenous cannabinoids, anandamide and 2-arachidonoyl glycerol (2-AG) under his supervision. Finally in 1990s, researchers in St. Louis University School of Medicine discovered cannabinoid receptors. After discovery of these two endogenous systems, we found that these systems are involving in many physiological functions besides their psychopharmacological activities. I hypothesize here, the story of opium and hashish can be repeated more quickly for other psychotropic herbs because we are armed to cheminformatics nowadays. In this oration, I will describe a molecular dynamic methodology that generates a list of high-binding small molecule ligands found in psychoactive herbs like Passiflora incarnate, Turnera diffusa var. aphrodisiaca, Eschscholzia californica, Lobelia inflate, Aquilegia Canadensis, Juniperus virginiana, etc. for selected orphan G protein-coupled receptors.

Speaker
Biography:

A Lecturer at the Department of Pharmacognosy and Medicinal Plants/ College of Pharmacy/ University of Baghdad. Her main research interest is in phytotherapy and herbal medicine.She has many research articles published in this aspect. She is also a humanitarian activist.

Abstract:

The present study has been focused to assess the anti-inflammatory activity and  healing effects of the aqueous extract of Hibiscus sabdariffa L. flowers on induced arthritis in mice and compare it with meloxicam (Mobic®), one of the most conventional drugs used to treat arthritis. The water extract of Hibiscus sabdariffa was administered orally at a dose of 300 mg/kg, 400 mg/kg and 500 mg/kg body weight for 14 days after induction of arthritis with incomplete fruend's adjuvant. (T1, T2 and T3) showed a significant increase in body weight when compared with T4, negative and positive control groups. A significant decrease in the levels of RBC and Hb was observed in all groups subjected to arthritic (T1,T2,T3,T4 and T5) when compared to the negative group (T6). The administration of the aqueous extract of Hibiscus sabdariffa L. flowers to arthritic mice in (T1, T2 and T3) improved the levels of Hb and RBC to near normal. A significant reduction (P≤0.01) in spleen weight ,WBC, ESR, CPR and serum copper level was found at all treatment groups with the water extract of Hibiscus sabdariffa in comparison with the groups treated with meloxicam, the positive and the negative.(T1, T2 and T3) reveled a significant (P≤0.01) reduction of the inflammation in comparison with the other treatment groups ( T4, T5). A better activity was observed at 500mg/kg body weight in  mice.

Speaker
Biography:

will be updated soon

Abstract:

Flurbiprofen is one of the most potent nonsteroidal anti-inflammatory drugs. It is widely used for relief of pain in patients suffering from rheumatic diseases, migraine, sore throat and primary dysmenorrhea. However, its aqueous solubility is very low and hinders the skin permeation. Thus, it is imperative to develop such a drug delivery systems which can improve its aqueous solubility and hence improve the skin permeation and therapeutic compliance. Micro-emulsions have been also proven to increase the cutaneous absorption of lipophilic drugs as compared to conventional vehicles. Micro-emulsion is thermodynamically stable emulsion that has the capacity to ‘hide/solubilize’ water-insoluble molecules within a continuous oil phase.Therefore, flurbiprofen was converted to Easters through chemical reactions with alcohols such as methanol, ethanol, propanol and butanol. The product was further treated with hydrazine to get hydrazide. The solubility of the parent drug Flurbiprofen and the products were solubilized in micro-emulsions formed using various surfactants like ionic, non-ionic and zwitterions. It has been concluded that the product was more soluble than the parent compound. The biological activities of these were also investigated. The outcome was very promising and the product was more active than the parent compound. It therefore concluded that in this way we can not only enhance the solubility of the drug, increase its bioactivity but also reduces the risk of stomach cancer.