In order to highlight the importance of dissolution testing in pharmaceutical industry as a tool in drug development and quality control, Society for Pharmaceutical Dissolution Science (SPDS) conducted its 2nd annual international convention DISSO ASIA 2014 between May 5th and 6th 2014 in Mumbai.
Dissolution testing is required for all solid oral pharmacopoeial dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect. Disintegration was originally thought to be this characteristic. The United States Pharmacopeia (USP) introduced its disintegration test in 1950. With advances in methodology, the disintegration test was found to be too insensitive, and dissolution test methods were introduced in the USP in 1968.
Experts deliberated that Dissolution is principally useful as a Quality Control test and is poised to gain importance as a research and development (R&D)tool for Indian academic institutions and pharma industry.
Organised under the guidance of founder president of SPDS, Vijay Kshirsagar chief executive officer, of Track Consultancy, Dr Nandakumar Chodankar, chief executive officer, A Solution Pharmaceuticals and the organizing secretary, Dr L Ramaswamy, managing director of Sotax India, the scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD, Pharmaceutics, Bombay College of Pharmacy, Mumbai. Speakers deliberated on new technology, innovation and issues related to dissolution. Around 150 delegates from industry and academia attended the event. Sotax India was the platinum partner of the event.
"Traditionally developed for solid oral dosage forms, use of dissolution testing has been widened to a variety of dosage forms such as semi solid, liposomes, nano particles, parenteral preparations in the last few years," explained Dr Ramaswamy.
The event comprised of plenary lecture, poster exhibits, panel discussion and exhibits. Speakers drew the conclusion that a lot of progress has been made during the last three decades from the aspect of standardisation and harmonisation of regulations. Vijay Kshirsagar, director, TRAC Consulting, Mumbai spoke on the Relevance of Current Batch Centric BE Studies, Dr Vinod Shah, Ex. US FDA, Pharmaceutical Consultant, USA spoke on FDA/USP Perspectives on Dissolution Testing from Regulatory Filing point of view.
Prof. Dr Jean Michel Cardot, Professor, Department of Biopharmaceutics, and Pharmaceutical Technology, Auvergne University, France spoke on In-Vitro Dissolution as in Vivo Surrogate; Samir Haddouchi, Managing Director, SPS Pharma Services, Clermont Ferrand – France spoke on Challenges and Solutions to Dissolution Testing of Non-Oral Formulations; Dr. Umesh Banakar, Professor and President, Banakar Consultancy Services, USA spoke on Biosimilars - The Emerging Frontier for Generics: Role of Dissolution Testing; and Michel Magnier, Product Manager, SOTAX AG spoke on Automation for Dissolution Testing.
Bryan Crist, Manager, Scientific Affairs, Agilent technologies, USA spoke on Validation of Components and data of Automated Dissolution Methods; Prof. Dr. Sompol Prakongpan, Professor of Pharmacy, Burapha University, Thailand spoke on Biowaiver of Biopharmaceutics Classification System Class III Drug Products; Dr. Sid Bhoopathy, Chief Operating Officer, Absorption Systems, USA spoke on Strategies for Establishing Equivalence of Complex Drug Products and Dr. Flavian Stefan Radulescu, University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania spoke on Correlation between rheology, in-vitro release and in- vivo performance of topical dosage forms.
The International Symposium was inaugurated by Dr. GD Yadav, the Vice Chancellor of Institute of Chemical Technology (ICT), Mumbai. Dr.Vatlamudi Rao, who is the current President of IPA ( Indian Pharmaceutical Association) was the Guest of Honor. In his address he has expressed that IPA shall support SPDS and do collaborative programmes across the country. SPDS also launched a Desk Book of Pharmaceutical Dissolution Science on the occasion authored by more than 10 eminent authors and edited by Dr Sandeep Tiwari, Dr.Umesh Banakar and Dr.Vinod Shah.
Dr. Vinod Shah and Dr. Umesh Banakar were awarded with the SPDS excellence award for their immense contribution to the field of Dissolution Science by president Vinay Kshisagar and the Dr. Mangal Nagasenkar, Scientific Committee chairman and the organisers.
There was also a Panel Discussion on “Handling dissolution Challenges” by eminent professionals from the Pharmaceutical Industry. Specifically designed for all the professionals from R&D, QA and QC as well as the Academia, SPDS is planning to organise DISSO America in USA next year.