Seminar on Dissolution Challenges-Regulatory Perspective held at JSS University, Mysore
Disso 2013, the two-day national seminar on ‘Dissolution Challenges-Regulatory Perspective’ recently concluded at Department of Pharmaceutics, JSS College of Pharmacy (off campus JSS University, Mysore), Udhagamandalam. The welcome address was given by Dr K Elango, Principal, JSS College of Pharmacy, Udhagamandalam. Over 250 delegates from within India and abroad participated in the seminar.
Dr VP Shah, Former, Senior Research Scientist, US FDA, VPS Consulting, MD, US; Dr Suresh Venkataram, Chief Executive Officer, Semler Research India Bangalore; Dr L Ramaswamy, General Secretary-SPDS and Managing Director-Sotax India; Ramsingar Pal-General Manager (Technical), Sotax India, Mumbai; Aditya Marfatia, Director Electrolab, Mumbai; H Raghunandan, Associate professor, JSS College of Pharmacy, Mysore; Dr B Suresh, Vice chancellor, JSS University, Mysore; Prof K Chinnaswamy and Dr K Gowthamarajan, Prof and Head, Department of Pharmaceutics, JSS College of Pharmacy, Udhagamandalam, graced the occasion.
Gowthamarajan presented the genesis of the conference and highlighted the importance and need of dissolution. Chinnaswamy, Emeritus Professor and guest of honour, addressed the audience and also highlighted scholarships offered by Tamilnadu Pharmaceutical Sciences Welfare Trust and seven students were awarded with cash prize and certificates.
Suresh delivered the presidential address and highlighted the recent trends in dissolution and monographs for herbal drugs in upcoming Indian Pharmacopoeia. He also addressed the challenges being faced by industry in times of bio waivers and generic drug development with particular emphasis on biological, vaccines and monoclonal antibodies.
The first scientific session was initiated by Shah where delivered a talk on Dissolution: Its place in pharmaceutical development and manufacturing, what is bioequivalence and how to document it, regulatory requirements and regulatory applications, and drug release from novel dosage forms.
The second scientific session was conducted by Venkataram and delivered talk on topics, science of dissolution, types of dissolution apparatus and selection of dissolution medium and advanced concepts in dissolution methodology (IVIVC, statistical Analysis, f2). This session was followed by a lecture by Raghunandan on Dissolution requirements for ANDA filling and Gowthamarajan on Herbal Dissolution.
Ramaswamy introduced the Society for Pharmaceutical Dissolution Science (SPDS) and activities conducted by the Society. Pal spoke about Flow-through cell (USP IV) methods and its application for novel drug delivery systems.
EP News Bureau — Mumbai
