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Scientific Program | Bioavalibility Conferences | Meetings International | 2018 | 2019

World Congress on

Bioavailability & Bioequivalence: BA/BE Studies Summit

Tokyo, Japan    August 06-07, 2018

Program Schedule

Monday, August 06 , 10:20-10:50

Meetings International - BABE 2018 Conference Keynote Speaker M R Mozafari photo

Keynote Forum

M R Mozafari

Australasian Nanoscience and Nanotechnology Initiative, Australia

Title

Application of nanocarrier systems for improving the bioavailability of nutraceuticals

Biography

Expert in Nano-biotechnology, Encapsulation & Targeting of Bioactive agents with substantial number of publications, 4 Patents, 5 Books & several Book-chapters. Author of the first book on Nanoliposomes; completed many industrial research projects, developed methods (e.g. Mozafari Method) for large-scale manufacture of controlled-release systems without using toxic agents. Recently introduced a novel technology for the encapsulation and delivery of bioactive material called "Tocosome".

Abstract

Nutraceutical can be defined as a food substance, a functional food or dietary supplement, which provides Human body with medical or health benefits, including disease prevention and therapy. It consists of food supplements, herbal products, probiotics, prebiotics, and medicinal foods used for prevention and treatment of various diseases. Consumption of nutraceutical compounds is a natural way to achieve therapeutic outcome with minimal or no side effects. These compounds, however, are subject to degradation as a result of exposure to environmental factors such as humidity, oxygen, heat, and light. Nanocarrier systems are very promising encapsulation technologies for the nutraceutical industry. Protection of sensitive bioactive molecules, storage stability, high loading capacity, enhanced bioavailability, and sustained-release mechanism are among the many advantages offered by nanocarrier technology. Nanocarrier formulations have already resulted in numerous marketed pharmaceutical products. In addition, proof-of-principle studies for nanocarrier systems providing enhanced oral bioactive uptake are available. By providing a comparatively more intimate contact with the absorption membrane, a prolonged gastro intestinal residence time and/or exhibiting permeation enhancing properties, absorption can be strongly improved by encapsulating bioactive material using nanocarriers. This entry reviews various aspects of nanocarrier technology including their main physicochemical properties, generally employed preparation methods and their application in the nutraceutical industry.

Monday, August 06 , 10:20-10:50

Meetings International - BABE 2018 Conference Keynote Speaker Yuan Chen photo

Keynote Forum

Yuan Chen

Genentech, USA

Title

Understanding BE data using physiologically-based pharmacokinetic (PBPK) modelling

Biography

Yuan Chen is a Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Yuan has nearly 20 years of experience in the drug metabolism and pharmacokinetics discipline working at Roche and Genentech. She has been DMPK project lead for many drug discovery and development projects, and contributed to many clinical candidate nomination and filing of IND to the regulatory authorities. Yuan’s current research focus is on physiologically-based pharmacokinetic (PBPK) modeling for the prediction of human PK, absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort at Genentech and has been active member on IQ PBPK expert working groups.

 

Abstract

TBD

Monday, August 06 , 11:40-12:10

Meetings International - BABE 2018 Conference Keynote Speaker InWook Choi photo

Keynote Forum

InWook Choi

Korea Food Research Institute, Republic of Korea

Title

Effect of catechol o-methyl transferase inhibitor on anti-inflammatory activity of luteolin metabolites

Biography

Dr. Choi has worked with great enthusiasm and endeavor for developing functional foods or pharmaceutical ingredients from animal and plant resources and commercializing them. Currently, He is interested in developing the system inferring functional properties of natural extracts (Bio-FINE).  The system is based on bio-information that can be extracted by comparing differently expressing genes between normal and natural extracts fed animals.  Through the system, various functional properties of single as well as combinatorial natural extracts can be ranked and further utilized for commercialization.

Abstract

Although luteolin is known to have potent anti-inflammatory activities, much less information has been provided on such activities of its hepatic metabolites. Luteolin was subjected to hepatic metabolism in HepG2 cells either without or with catechol O-methyl transferase (COMT) inhibitor. To identify hepatic metabolites of luteolin without (LMs) or with COMT inhibitor (LMs+CI), metabolites were treated by ß-glucuronidase and sulfatase, and found that they were composed of glucuronide and sulfate conjugates of diosmetin in LMs or these conjugates of luteolin in LMs+CI. LMs and LMs+CI were examined for their anti-inflammatory activities on LPS stimulated Raw 264.7 cells. Expression of iNOS and production of nitric oxide and pro-inflammatory cytokines such as TNF-α, IL-1ß and IL-6 were suppressed more effectively by the treatment with LMs+CI than LMs. Our data provide a new insight on possible improvement in functional properties of luteolin on target cells by modifying their metabolic pathway in hepatocytes

 

  • Emerging Bioavailability & Bioequivalence Studies | Advances in BA&BE | BA/BE of Biologic & Biosimilar | Drug Metabolism | New Approaches to Beat Multi-Drug Resistance: Natural and QSAR-designed Antimicrobial Peptides Bioequivalence Protocol: In-Vitro / In-Vivo Studies

Monday, August 06, 12:10-12:55

Meetings International - BABE 2018 Conference Session Speaker Gilberto De Nucci photo

Session Introduction

Gilberto De Nucci

Brazilian physician, Brazil

Title

The Use of Healthy Volunteers for Bioequivalence of antineoplastic drugs

Biography

He holds a PhD in Pharmacology from the Royal College of Surgeons of England (University of London, 1986) and holds a PhD in Pharmacology from the University of SAo Paulo at RibeirAo Preto Medical School (1981). He has been a titular member of the National Academy of Medicine since 2003 and the National Academy of Pharmacy since 2009. He is currently an adjunct professor in the Department of Pharmacology of the Faculty of Medical Sciences of the State University of Campinas (UNICAMP) and a full professor of the Pharmacology Department of the Instituto de Biomedical Sciences of the University of São Paulo. Has experience in the field of Clinical and General Pharmacology (cardiovascular and inflammation).

Abstract

TBA

Monday, August 06, 13:45-14:05

Meetings International - BABE 2018 Conference Session Speaker Mohamed Fahmy Zeid photo

Mohamed Fahmy Zeid

Alexandria University, Egypt

Title

Emerging Bioavailability & Bioequivalence Studies

Biography

He completed MBBCH very good with honors on Nov 1982 and completed Master of General Surgery in 1987.He did fellowship in the department of Neurosurgery in 1994.He did doctorate degree in Neurological surgery in 1994.and member congress of American Neurological Surgeons on 2000 He is the House officerin Ministry of Health Hospitals and Alexandria university Hospitals for one year from 1983 to 1984.He worked as physician in the Ministry of Health Hospitals from 1984 to 1987.He is Registrar of Neurosurgery in private hospital from 1987 to 1988.He is Assistant lecturer of Neurosurgical department of Alexandria University Hospitals from 1988 to 1994.He is chief consultant of Neurosurgery in Saqr Hospitals, UAE from 2000 to 2003.He visit to Neurological surgery department, Royal College of Medicine,London in 2001. He is working as Professor of Neurosurgery department at Alexandria University from 2010 to till date.

Abstract

TBA

Monday, August 06, 14:05 - 14:25

Meetings International - BABE 2018 Conference Session Speaker Gulay Yelken Demirel photo

Gulay Yelken Demirel

University of Gazi, Turkey

Title

Effect of Formulation Development and API Characteristics on Fast Dissolving Dosage Forms Bioequivalence Studies

Biography

Gulay Yelken Demirel has a degree in Department of Chemistry from University of Gazi (Ankara, Turkey) followed by a master degree in Medicinal and Pharmaceutical Chemistry (faculty of pharmacy) from the same university and studied Executive Master of Business Administration at Istanbul University. Currently, She has an ongoing PhD in Medicinal and Pharmaceutical Chemistry(faculty of pharmacy) at Yeditepe University. She is also a Turkish Patent Attorney. She has eleven years’ experience in R&D department of generic pharmaceutical companies. She worked as formulation scientist at the Pharmaceutical Technology Department of Nobel Pharmaceuticals. Presently, She owns the R&D Project Group Executive position at Sanovel Pharmaceuticals. She has several published papers in the academic areas and over 100 patents& patent applications in the industrial areas on pharmaceutical dosage forms.

 

Abstract

Fast Dissolving Dosage Forms represent excellent opportunities for life cycle management to the pharmaceutical companies. They have many advantages like ease of swallowing, administration without water, quick onset of action for improving both patient convenience and compliance as benefits for patient; extended life cycle, product differentiation, patent protection... But there are some challenges for formulation development studies for the generic companies. In the sense of generic companies, developing an Fast Dissolving Formulation version of an existing immediate-release product means that the two formulations must be bioequivalent and this can be challenging for in-vivo studies especially if the method of taste masking retards the dissolution rate of the active ingredient after disintegration. On the other hand, what will be the effects on the BE studies if the API has significant degree of buccal or sublingual absorption occurs in this case?

 

Monday, August 06, 14:25 - 14:45

Meetings International - BABE 2018 Conference Session Speaker Yesenia Cevallos photo

Yesenia Cevallos

University of Calabria, Italy

Title

Newly approved antimicrobial agents: where do they belong?

Biography

Yesenia Elizabeth Cevallos Villacrés is an Electronic and Telecommunication Engineer from National Polytechnic in Ecuador, 2001. She has an Information Technology Master’s degree from Technical University of Ambato in Ecuador, 2010. She is an Associate Professor at National University of Chimborazo, Ecuador. Currently, she is a PhD student at University of Calabria, Italy. She has articles published in network and digital communications area in journals in Ecuador. Her main publications as PhD student is: A digital communication analysis of gene expression of proteins in biological systems: A layered network model view.

Abstract

TBA

Monday, August 06, 14:45-15:05

Monday, August 06, 15:05 - 15:25

Meetings International - BABE 2018 Conference Session Speaker Yahdiana Harahap photo

Yahdiana Harahap

Universitas Indonesia, Indonesia

Title

A Bioequivalence Study of Two Memantine Hydrochloride Film Coated Tablets Formulations Assessed in Healthy Indonesian Subjects

Biography

Dr. Yahdiana Harahap is a Professor in the field of Pharmaceutical Chemistry especially Bioanaysis related to bioequivalence study and DNA Adduct. She received her Master Degree in 1994 and Doctoral degree in 2003 from Department of Pharmacy, Faculty of Mathematics and Natural Sciences, Institute Teknologi Bandung. She has been The Head of Bioavailability-Bioequivalence Laboratory Faculty of Pharmacy Universitas Indonesia since 2008. She serves as member of Expert Council Indonesian Pharmacist Association, reviewer in several international journals, President elected on Asian Federation of Pharmaceutical Science, Head of Sub Collegium Indonesia Pharmaceutical Industry and as The Head of Pharmacy Division in Indonesian Accreditation Agency for Higher Education in Health (LAM PT-Kes). She has generated more than 80 scientific works published in international and national journals, thus presented them in national and international conferences.

 

Abstract

Statement of the problem: Memantine hydrochloride is an N-Methyl-D-aspartate (NMDA) receptor antagonist and approved for treatment of moderate to severe Alzheimer’s disease. It is compulsory for the generic product of memantine hydrochloride to conduct the bioequivalence study. Bioequivalence studies are important to compare the systemic exposure profile of a test product to that of a reference product. This study was performed to investigate the pharmacokinetics and bioavailability of two memantine hydrochloride film coated tablet formulations in order to prove bioequivalence between the two formulations.

Methods: The study was a single dose, open label, randomized, two way cross over in 19 healthy subjects under fasting condition. The wash out period was five weeks. Blood samples were obtained prior to dosing and at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration. Plasma concentration of memantine HCl was monitored using liquid chromatography tandem mass spectrometry. The pharmacokinetics parameter AUC 0-24 h and Cmax were tested for bioequivalence after log transformation of data and ratios of Tmax were evaluated non parametrically. Result: the point estimates and 90% confidence interval for AUC 0-72 h and Cmax were 97.43 to 104.13% and 97.15 to 105.96% respectively.  Conclusion: The results indicate that two formulations of memantine  HCl were bioequivalent thus may be prescribed interchangeably. 

Monday, August 06, 15:25 - 15:45

Meetings International - BABE 2018 Conference Session Speaker Sepideh KHORASANI photo

Sepideh KHORASANI

Shahid Bahonar University of Kerman, Iran

Title

Formulation of nanocarriers composed of millet protein and tocopherols to control bioavailability of lipophilic food components

Biography

Dr Khorasani is Assistant Professor in the Department of Food Science and Technology, Shahid-Bahonar University, Kerman, Iran. She is interested in research and development in the field of Clinical Pharmacology, Food Processing and Food Nanotechnology. She has been supervising scientific projects on the Post Harvest of different agricultural products using herbal and plant-derived compounds. She has several years of teaching and lecturing experience as well as supervision of postgraduate research students

Abstract

Millet is a general word used to refer to a wide range of small-seeded annual grasses, which have been grown for thousands of years in different parts of the world. They are still the main source of food and nutrition in some countries in Africa and Asia. Millet seeds are rich in oil and contain essential fatty acids and essential amino acids as well as a number of minerals. We have been formulating nanocarrier systems employing proso millet protein and different tocopherol homologues for the nanoencapsulation of hydrophobic compounds. These formulations possess added nutritional value, are cost-effective and are able to increase the bioavailability of the encapsulated material.  Proso millet protein was extracted by either wet milling or ethanol and then used as the wall material together with tocopherol homologues to encapsulate curcumin and omega fatty acids. The formulated nanocarrier systems depicted spherical morphologies and had diameters in the range of 180–240nm and polydispersity index (PdI) around 0.2–0.3. The entrapment efficiency for omega fatty acids ranged from 47.5% to 68.5% and for curcumin ranged from 34.0% to 56.5%. It was observed that millet protein extracted by ethanol exhibited better performance than that extracted by the wet milling process. The encapsulated omega fatty acids and curcumin exhibited a lower degradation rate than corresponding free compounds at 60°C. The encapsulation showed no negative effect on the antioxidant activity of curcumin as assessed by the DPPH and ABTS assays. In conclusion, results of the present study suggest that the composite nanocarrier systems formulated using millet protein and different tocopherol homologues have great potential for the nanoencapsulation of lipophilic compounds and can increase the bioavailability of food compounds significantly

Monday, August 06, 15:45 - 16:05

Meetings International - BABE 2018 Conference Session Speaker Jacob A. Kolawole photo

Jacob A. Kolawole

University of Jos, Nigeria

Title

In vitro and in silico drug-food interaction: an evaluation of metformin and green tea interactions

Biography

Jacob Adegboyega KOLAWOLE, PhD, FPSN, FPCPharm. FIPAN, completed his PhD at the age of 38 years from the Ahmadu Bello University, Zaria and The Robert Gordon, University, Aberdeen, UK (1996). He is the Dean, Faculty of Pharmaceutical Sciences, University of Jos and Consultant to West African Health Organization, on development of guidelines and training manuals for, Pharmaceutical Finished products; Pharmaceutical Raw Materials; Standard Operating Procedures for Laboratories; Bioavalability /Bioequivalent. He has more than 40 publications in international journals.

 

Abstract

Food-drug interaction is a consequence of physical, chemical or physiological relationship between a drug and food. Failure to identify and properly manage food-drug interaction can lead to serious consequences such as reduction in absorption of certain orally administered drugs thereby leading to failure of treatments. This study sort to explore the effect of green tea on Metformin uses both in-vitro dissolution test and in-silico docking interactions models. Dissolution test was carried out on Metformin alone and Metformin in the presence of green tea using the official dissolution medium, phosphate buffer pH 6.8 and sampling done at USP timing intervals. Docking studies was carried out by using 10 phenolic compounds and metformin in the active site of the AMPK crystal structure, 4ZHX.pdb.  Metformin alone complied with the USP requirement of 70% drug release while Metformin release in the presence of green tea was less than 70% at 45minutes. Phenolic constituents of green tea; (-)-epigallocatechine, epicatechine, theanine and theophylline were seen to form complexes with metformin through covalent bonding in the active site of AMPK.  This study was able to establish the interaction of green tea on metformin dissolution profile and possible binding interactions in the binding site of AMPK enzyme. It was therefore concluded that the presence of green tea in the dissolution media along with metformin caused a decrease in its dissolution profile due to complex formation and that the catechins and theanine constituents of green tea could possibly compete for binding site residues with metformin.

 

Monday, August 06, 16:25 - 16:45

Title

Thaumatin protein from african thaumatococcus danielli in formulated organic drink and snack significantly improved the nutritional status in wistar rats

Biography

Oyebamiji Emmanuel Aanuoluwapo is a Trained/seasoned Nutritionist, a member of nutrition society of Nigeria, a nutrition columnist, speaker on SDGS and ethical leadership, he started his nutrition carrier from Federal University of Agriculture Abeokuta then Proceeded to university of Ibadan for his master degree in human nutrition, he has passion to solve health challenges with nutrition which gave birth to nutrition clinic where he is a co-founder, he has served as a volunteer for different organisation on health and leadership within south west Nigeria.

 

Abstract

Micronutrient deficiencies is responsible for an estimated 1.1 million of the 3.1 million child deaths that occur each year as a result of under nutrition. Malnutrition is particularly prevalent in Sub-Saharan Africa requiring urgent intervention through a sustainable integrated innovation. This work investigates the effect of thaumatin in formulated nutritional drink and snack on the nutritional status of Wistar rats. Cocoa, Moringa and composite flour in combination with Thaumatin isolated from the West African Thaumatococcus danielli as an organic sweetener.

Cocoa powder and Moringa leaf powder were locally sourced from organically grown farms in South Western Nigeria. Thaumatin was isolated from the fruit obtained from Thaumatococcus danielli collected from the wild. Isolation of Thaumatin protein was carried out in accordance with standard procedure. Twelve Wistar rats of an average weight of 120 g, were acclimatized for one week then subjected to the specially formulated organic drinks and snacks

The results revealed a significant (p≤0.05) increase in vitamin A (37.55. ±0.821), calcium value (26.45±0.821), zinc (3.83±0.314), iron (28.38±1.20) and iodine value of 1.49±0.62 for group one and group two values are Vitamin A (36.10+0.65), calcium value (26.83+0.38), Zinc (4.10+0.341), iron (29.08+ 1.11) and iodine value of 1.49+0.49 for group two while group three which is the control has micronutrient value of Vitamin A (27.08+0.51), calcium value (19.15+0.60), zinc (1.87+0.30), iron (20.40+0.91) and iodine value of 1.05+0.037.  Based on the Results of this study suggest that formulated drinks and snacks from cocoa, Moringa and Thaumatin protein produced a significant effect on the growth and micro nutrient levels of the experimental rats and thus hold potentials in combatting hidden hunger and malnutrition.

Monday, August 06, 16:45 - 17:05

Meetings International - BABE 2018 Conference Session Speaker Andras Fodor photo

Andras Fodor

University of Szeged, Hungary

Title

Bioavailability in the gut (for anti- coccidian activity) and in the blood (for tissue toxicity) of orally administered antimicrobial peptides from Xenorhabdus budapestensis

Biography

Qualifications are:Diploma in Genetics: biologist & Teacher Certification for High School, 234/1964; PhD from the Committee for Doctoral Awards of the Hungarian Academy of Sciences, October 7, 1974, Budapest, Hungary; PhD Candidate of Biological Sciences; (No. 6.162), Biological Doctoral Degree: D-1674/1974, Eotvos Lorand University, Budapest, Hungary, (December 3, 1974) ; Habilitation Committee of the Eotvos Lorand University, Budapest, Hungary, (December 13, 2000 ); Szechenyi Professorship Award (March 19, 1999) from the Hungarian Ministry of Education; D. Sc: Submitted to Committee for Doctoral Awards of the Hungarian Academy of Sciences, Budapest, Hungary (2003) ; Fulbright Research Fellow: University of Wisconsin-Madison, Madison WI USA 2015. Andras Fodor has a total Research experience of 48 years, has been actively publishing for 39 years; and a teaching experience (Genetics, Microbial genetics, Biology for undergraduates, master graduate and PhD graduate students) of 34 years

Abstract

Coccidiosis is the result of the cooperation of a prokaryotic (Clostridium perfringens) and of a eukaryotic (Eimeria tenella) pathogen. Objective: in vivo tests on the efficacy of the bio-preparation Xenofood, (active on both pathogens in vitro), on C. perfringens colony forming units (CFU). Methods: Xenofood is a mixture of an autoclaved, mid-stationary phase culture of Xenorhabdus budapestensis and X. szentirmaii grown in conventional “starter” and “grower” chicken food. The thermo-stability, and the trypsin and pepsin resistance of the antimicrobials were determined.  1-day old (Ross) broiler cockerels were kept on a Xenofood diet for 42 days. Body weights were measured daily, and growth and food conversion rates were monitored for 24-d. Results: Antimicrobial compounds were heat-stable, and trypsin and pepsin resistant. No chickens died. No significant differences either in growth, or in food conversion rates between the control and Xenofood-fed groups were detected.  The larger bursa, and smaller spleen weights indirectly indicated an elevated humoral immune activity. The number of CFU in Xenofood-fed birds significantly decreased. Conclusions: The arguments for and against Xenofood as an anticoccidial tool should be taken into considerations. The cell-free cultures of X. budapestensis and X. szentirmaii exerted strong antimicrobial effects on C. perfringens, and an anticoccidial effect on E. tenella in previous in vitro tests, but also exerted cytotoxic effects on permanent chicken liver (LMH) cells in vitro. Xenofood proved gastrointestinal active without any adverse effects, suggesting that oral application was efficient to reduce C. perfringens CFU without any detectable sign of biohazard.

 

Tuesday, August 07 , 10:10-10:40

Meetings International - BABE 2018 Conference Keynote Speaker Jasminka Ilich-Ernst photo

Keynote Forum

Jasminka Ilich-Ernst

Institute for Successful Longevity Florida State University

Title

TBA

Biography

TBA

Abstract

TBA

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