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The Role of Material Properties in Dissolution Science

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Hourly Schedule

Agenda

11:00 am - 11:05 am
Welcome
Speakers:
Vinod P. Shah
11:05 am - 11:20 am
The Role of Material Properties in Dissolution Science
Speakers:
Arvind Bansal
11:20 am - 12:00 pm
Exploring in vivo supersaturation
Speakers:
Patrick Augustijns
12:00 pm - 12:40 pm
Crystal engineering approaches to modulate solubility
Speakers:
Ashwini Kumar Nangia
12:40 pm - 01:00 pm
Panel Discussion. Questions & Answers.
Speakers:
Arvind Bansal
Vinod P. Shah
Vinod P. Shah
Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidance for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 330 scientific papers and co-editor of four books. Dr. Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences; IDMA Eminent Pharmaceutical Analyst Award (India); Honorary Doctorate from Semmelweis University, Budapest, Hungary; Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award.
Arvind Bansal
Arvind Bansal
Dr Arvind Kumar Bansal is currently Professor, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) - SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Before joining NIPER, Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement - ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He was the first Indian, working in India, to be awarded this Fellow status. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 650 industry-sponsored projects, granted 12 patents, filed 27 patents, and published over 200 research and review articles. He has total citations of >13,200, with h-index of 62, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’.
Patrick Augustijns
Patrick Augustijns
Professor at the University of Leuven (Belgium)
Prof. Patrick Augustijns has a Pharmacy degree, a Master in Medical Sciences and a Ph.D. in Pharmaceutical Sciences. Prior to becoming a professor at the University of Leuven (Belgium), he performed postdoctoral research at the University of Kansas and at GSK (North Carolina). In 2003, Patrick Augustijns became chairman of Drug Delivery and Disposition. The laboratory has a strong track record in the biorelevant profiling of intestinal drug absorption, covering all underlying processes including dissolution, precipitation, degradation and permeation. For this purpose, a wide range of simulation models is available, including the in vitro Caco-2 cell culture system, the Ussing chambers system and the in situ intestinal perfusion system. In addition, Drug Delivery and Disposition is able and licensed to perform whole animal absorption and pharmacokinetic experiments. Physiology-based pharmacokinetic modelling is available to extrapolate experimental data to human pharmacokinetics. One of the lab’s major research topics involves the aspiration and in-depth characterization of gastrointestinal fluids, including the evaluation of intraluminal drug and formulation behavior in humans. The latter involves the bio-relevant and predictive evaluation of absorption-enabling strategies, including solubilization and supersaturation of poorly soluble drugs. As age or disease may add an additional layer of (patho)physiological variability, dedicated projects have also been initiated to profile gastrointestinal fluid variability in children, elderly, and patients with Parkinson’s disease. All aspiration and absorption studies are supported by well-developed analytical equipment (LC-UV, -fluo, -MS/MS) to assess the concentrations of endogenous compounds found in the intestinal fluids, as well as of drugs and excipients in biological matrices. Patrick Augustijns is (co)author of ± 350 (peer reviewed) papers in international journals and more than 350 presentations at scientific meetings. Since 2008, Patrick Augustijns is AAPS-fellow. In January 2019, he has been awarded an honorary doctorate from Uppsala University.
Ashwini Kumar Nangia
Ashwini Kumar Nangia
Professor of Chemistry at University of Hyderabad
Prof. Ashwini Kumar Nangia is a Senior Professor of Chemistry at University of Hyderabad. He completed MSc from IIT Kanpur (1983) and PhD from Yale University (1988). He started his professional career at UoH in 1989 as Lecturer and was promoted to Professor in 2002. His research group focuses on crystal engineering topics – structure design, inclusion compounds, polymorphism, cocrystals, salts and eutectics, and the applications of these solid forms in pharmaceutical sciences for drug translation. He is a Fellow of three National Science Academies – INSA New Delhi, IASc Bangalore and NASI, Allahabad. He is recipient of the JC Bose Fellowship from DST. He was awarded the Golden Jubilee Commemoration Medal (Chemical Sciences, 2016) of INSA and the Prof. L. K. Doraiswamy Chemcon Distinguished Speaker Award for 2016 by IIChE. He has international research collaborations with Russia, Singapore, UK and USA. He is on the Editorial Boards of subject journals, Crystal Growth & Design (ACS), CrystEngComm (RSC), Journal of Pharmaceutical Sciences (Wiley), Chemistry – An Asian Journal (Wiley-VCH). He was appointed Associate Editor of Acta Crystallographica, Section B, IUCr journals in 2017. He has published about 300 papers in peer reviewed international and national journals, filed 15 patents, has H index of 60 and over 14,000 citations. He was awarded the Golden Jubilee Commemoration medal of INSA (2016) and Prof. D. N. Dhar Memorial lecture of NASI (2018). He was recently appointed Member of SERB Empowered Committee and as Adjunct Professor at ICT Mumbai (UDCT). He is founder of spin off innovation and R&D venture Crystalin Research in 2010 under the banner “Chalk to Salt” at Technology Business Incubator facility on University campus. Crystalin Research completes a decade of successful functioning as a solid-state form modification and improvement venture in 2020. He was Director of CSIR-National Chemical Laboratory, Pune since March 2016 and completed his tenure successfully at the end of November 2020. He was Chairman of India’s first and largest Venture Center on NCL Innovation Park, co terminus with his tenure as Director, NCL. He re-joined University of Hyderabad as a Senior Professor of Chemistry in December 2020.

Date

Jun 11 2021
Expired!

Time

11:00 am - 1:00 pm

Location

Online

Category

Organizer

SPDS US Chapter
Phone
+1 (508) 886 3079

Speakers

  • Vinod P. Shah
    Vinod P. Shah
    Vinod P. Shah
    Vinod P. Shah

    Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidance for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 330 scientific papers and co-editor of four books.

    Dr. Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and FIP. Dr. Shah is a recipient of FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences; IDMA Eminent Pharmaceutical Analyst Award (India); Honorary Doctorate from Semmelweis University, Budapest, Hungary; Honorary Doctorate from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; AAPS Distinguished Pharmaceutical Scientist Award and AAPS Global Leader Award.

  • Arvind Bansal
    Arvind Bansal
    Arvind Bansal
    Arvind Bansal

    Dr Arvind Kumar Bansal is currently Professor, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) – SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Before joining NIPER, Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement – ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He was the first Indian, working in India, to be awarded this Fellow status. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 650 industry-sponsored projects, granted 12 patents, filed 27 patents, and published over 200 research and review articles. He has total citations of >13,200, with h-index of 62, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’.

  • Patrick Augustijns
    Patrick Augustijns Professor at the University of Leuven (Belgium)
    Patrick Augustijns
    Patrick Augustijns
    Professor at the University of Leuven (Belgium)

    Prof. Patrick Augustijns has a Pharmacy degree, a Master in Medical Sciences and a Ph.D. in Pharmaceutical Sciences. Prior to becoming a professor at the University of Leuven (Belgium), he performed postdoctoral research at the University of Kansas and at GSK (North Carolina). In 2003, Patrick Augustijns became chairman of Drug Delivery and Disposition. The laboratory has a strong track record in the biorelevant profiling of intestinal drug absorption, covering all underlying processes including dissolution, precipitation, degradation and permeation. For this purpose, a wide range of simulation models is available, including the in vitro Caco-2 cell culture system, the Ussing chambers system and the in situ intestinal perfusion system. In addition, Drug Delivery and Disposition is able and licensed to perform whole animal absorption and pharmacokinetic experiments. Physiology-based pharmacokinetic modelling is available to extrapolate experimental data to human pharmacokinetics. One of the lab’s major research topics involves the aspiration and in-depth characterization of gastrointestinal fluids, including the evaluation of intraluminal drug and formulation behavior in humans. The latter involves the bio-relevant and predictive evaluation of absorption-enabling strategies, including solubilization and supersaturation of poorly soluble drugs. As age or disease may add an additional layer of (patho)physiological variability, dedicated projects have also been initiated to profile gastrointestinal fluid variability in children, elderly, and patients with Parkinson’s disease. All aspiration and absorption studies are supported by well-developed analytical equipment (LC-UV, -fluo, -MS/MS) to assess the concentrations of endogenous compounds found in the intestinal fluids, as well as of drugs and excipients in biological matrices. Patrick Augustijns is (co)author of ± 350 (peer reviewed) papers in international journals and more than 350 presentations at scientific meetings. Since 2008, Patrick Augustijns is AAPS-fellow. In January 2019, he has been awarded an honorary doctorate from Uppsala University.

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