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Dissolution science to equip Indian companies in the domain of complex generics: Experts
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Shardul Nautiyal, Mumbai
June 29 , 2023
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Dissolution science has come up as an important subject that will allow and equip the Indian companies to enter into the domain of complex generics. Complex generics are today becoming an important part of any business model of any pharma company. Many businesses of generic drugs are not able to sustain the price erosion that it is facing.
So, more and more companies are moving towards these products. With this, there also comes a challenge of characterizing them and also meeting in vitro bioequivalence requirements that has been laid by the US FDA, said Prof. Arvind Bansal, scientific chair – SPDS and dean, National Institute of Pharmaceutical Education and Research (NIPER) on the sidelines of 12th annual international symposium on Dissolution Science and Applications under the theme ‘Importance of Dissolution Science and Technology in Drug Development and Quality Assurance’ in Mumbai recently.
Each medicine has its own delivery system and therefore dissolution testing is required to be done on a regular basis to determine the time and efficacy of medicine. Only a few major pharma companies are able to invest in automation for dissolution testing to meet the demands and standards of export and regulated markets were some of the other deliberations shared at the event.
The welcome address was done by Dr. L. Ramaswamy, general secretary, Society for Pharmaceutical Dissolution Science (SPDS) and Dr. Tina Morris, executive director, American Association of Pharmaceutical Sciences (AAPS), USA. Other dignitaries who addressed the sessions were Prof. Padma Devarajan, president – SPDS and Dr Vinod P Shah, Ex US FDA, Pharmaceutical Consultant, USA, among others.
Prof Bansal further explained that with the success of Indian companies in complex generics, companies will now have more financial and intellectual power to enter into the most challenging area of the pharmaceutical value chain that is the new molecular entities. Some companies are already playing with these models in a very modest way but in the future, this is likely to grow further as Indian companies gain confidence in the international arena.
Speaking on the sidelines of the conference, Dr Munira M Momin, scientific chair, SPDS and Principal, SVKM's Dr. Bhanuben Nanavati College of Pharmacy (BNCP), Mumbai said, “There is now increasing awareness around dissolution science based on the vision and success journey of thought leaders of the Society for Pharmaceutical Dissolution Science (SPDS) like Dr. L. Ramaswamy, general secretary, SPDS, Prof. Padma Devarajan, president, SPDS and Prof. Arvind Bansal, past scientific chair – SPDS. However, there is a need to design some bridge courses and organize events to develop industry academia linkages to propagate dissolution science amongst the students to help them get industry ready. Going further, in order to strengthen the academy – industry relationship, we can have one more conference on role of excipients in dissolution science which is very much relevant today.”
Dr Momin further added that another focus area is to develop a Centre of Excellence for Dissolution Science with the help of industry partners. Students have to be made aware of the dissolution science as it is the key to any product development and most importantly equipping the students with the knowledge on dissolution science is going to equip them for the industry going forward.
Dr Rajiv Desai, vice president, SPDS, while speaking on the subject of Life Cycle Management of the drug Product – Dissolution Analysis for determining characteristics said that dissolution testing is a requirement for all solid oral dosage forms and some other category products. It is an important parameter to be complied throughout the development life-cycle, product release testing and ongoing stability testing.
During the life cycle of the product, a number of changes take place like API/excipient source, formulation, pharmacopoeial dissolution method, Invitro- Invivo correlation, adverse drug effects etc. In the post approval inspection if any problems are noticed related to data integrity of dissolution/BA/BE data, it is going to be disastrous for the patient and the manufacturing company. So there is a need to monitor dissolution profile throughout the life cycle (product development/launch till its discontinuation).
Vijay Kshirsagar, director, TRAC Pharma Consulting, Mumbai, moderated a panel discussion on ‘Life Cycle Management Dissolution Characteristics of Drug Product’ in which Sajeev Chandran, director- ADDS Research, Generics, Packaging & IVIVC/Biopharmaceutics, Lupin and Dr. Rupesh Kelaskar, associate vice president, corporate quality control, FDC Ltd shared their presentations.
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