Aimed at spreading awareness in dissolution science as an important tool in drug development and quality control, Society for Pharmaceutical Dissolution Science (SPDS) conducted its 3rd Annual International Convention Disso India 2015 on August 31 and September 1, 2015 at Goa. The event aimed to promote introduction of new technology, innovation and had deliberations on various issues related to Dissolution. Disso India 2015 event witnessed eminent professionals from the pharmaceutical industry.
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. 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.
In the event, a Deskbook of Pharmaceutical Dissolution Science and Applications was also released at the hands of chief guest Dr. Prakash Mody, managing director, Unichem Laboratories Ltd. It is a first of its kind society launched deskbook in the world with contributions from 27 global experts in the subjects and written over 285 pages. The book edited by Dr Sandip Tiwari, Dr Umesh Bankar and Dr Vinod Shah comprises 15 chapters related to most modern development in the field of dissolution science and its applications.
Explains Editor of the Book Sandip Tiwari from USA, “Aim of the book is to provide academia, industry and research scientists an overview of basics and fundamentals in the dissolution science and testing, recent developments in instrumentation and automation, changing regulatory requirements and innovations in the area of dissolution science and dissolution/in-vitro release for novel dosage forms.”
Said Dr L Ramaswamy, general secretary, SPDS and managing director, Sotax India Pvt Ltd, “The chapters provide details about instrument operation, tips to overcome problems in design and development and adequate literature citations. The chapter also reveals methods of statistical analysis and interpretation of dissolution data, application of data in terms of correlation with bio-availability and bio-equivalence.”
He further said that the symposium is aimed at spreading awareness about advancement in dissolution science so that it could help scientists and manufacturers globally to come out with high quality products. We would be conducting similar symposiums in Europe-Turkey and USA to help pharmacists, regulators and academia to know more about the dissolution science and its applications.”
This event was organised under the chairmanship of renowned Salim A. Velji, director - Food and Drugs Administration, Goa and the organizing secretary, Anant Naik, deputy general manager-quality, Unichem Laboratories, Goa. The scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD & professor of pharmaceutics, Bombay College of Pharmacy, Mumbai. The event comprised of plenary lecture, panel discussion and exhibits. Dr Mody, chairman and managing director of Unichem Laboratories Ltd was the chief guest of the symposium and addressed the inauguration function. Salim Velji, chairman of the symposium released the scientific abstract book during the inauguration.
Disso India 2015 had exceptional global speakers. Dr. Vinod P. Shah, Ex. US FDA, pharmaceutical consultant, USA spoke on dissolution data in new and generic drug regulatory submissions: USFDA perspective. Dr. Suresh Venkatram, chief scientific officer, Semler Research, Bangalore, India spoke on bio-relevant and discriminating dissolution test methods. Samir Haddouchi, managing director, SPS Pharma Services, Clermont Ferrand, France spoke on dissolution studies for novel drug delivery systems.
Prof A. Atilla Hincal, founder and general manager, IDE Pharmaceutical Registration Biopharmaceutics Consultancy, Ankara, Turkey gave a low down on the regulatory aspects related to dissolution studies: European perspective.
Prof. Dr. Nevin Çelebi, Gazi University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Ankara, Turkey spoke on fed and fasted condition dissolution studies. Vijay Kshirsagar, director and CEO, TRAC Pharma Consulting, Mumbai, India spoke on Qbd approach in dissolution studies.
Vatsala Naageshwaran, director of operations, Absorption Systems, USA discussed about 'Advancing Methods for Equivalence of Ophthalmic and Topical Drug Products – A New Vision for the Future'. Prof. Imre Klebovich, Semmelweis University Department of Pharmaceutics, Budapest, Hungary enlightened on 'Predicting Drug Interactions from Dissolution Studies'. Dr. Sandip Tiwari, Actavis Laboratories FL, Inc., Florida, USA offered a scenario on the 'Recent Innovations in Dissolution Testing' while Prof. Constantin Mircioiu, president, Pharmaceutical Dept. Academy of Medical Sciences, Bucharest, Romania spoke on 'Statistical Sampling and Dissolution Data Analysis', Makarand Avachat, senior vice president, R & D - Formulations, Lupin Laboratories offered insights on 'Linking CQA and CPP to Clinically Relevant Dissolution Method'.
Dr Umesh Banakar, professor and president, Banakar Consulting Services, USA gave a perspective on the subject - Beyond guidances: Convincing Regulatory Authorities of Data Interpretation and Data Integrity.
While speaking on the sidelines of the conference, Anant Naik, organising secretary, SPDS concluded, “Goa being the pharma hub, the symposium like DISSO India are of great help for pharma industry in Goa to update their technical skills to keep in line with current expectations of international regulatory authorities.”
Disso India 2015 was specifically designed for all the professionals from R&D, QA and QC as well as the academia. Around 150 delegates participated in this mega symposium focussing on dissolution.