Formulating a Successful Pharmaceutical Product – The Three Key Considerations
Simerdeep Singh Gupta, MS, Ph.D. (Teva Pharmaceuticals)
NOTE THE LOCATION: SEASONS RESTAURANT
A drug product goes through a long journey before it reaches the patient. One of the key steps in this journey is the formulation of the dosage form. A formulation scientist design products ensuring optimum effectiveness and safety. In order to develop a successful product, there are three key attributes that formulation scientists must consider – performance, stability and manufacturability.
The first attribute is the performance of a product, in other words, the effectiveness. This may be the solubility of the product in body fluids, extension or delay of drug release, maximum concentration in a given time etc. Several factors affect the performance of the product, some of which may be the ingredients used, the microstructure of the formulation or the processing technique.
The second attribute is the stability of the product. If a drug product performs well and has good efficacy, but has poor shelf life stability, the product cannot be considered a successful one. It is important that the drug product remains stable, and without toxic bi-products. Not only should the formulation ingredients aid the stability of the API, but the processing technique should not compromise the stability of the final product.
The third attribute is manufacturability of a formulation. If a product performs as desired and has satisfactory stability, but is too complicated to be manufactured, a number of challenges may arise. A complicated manufacturing process could lead to harmful degradation products, uniformity issues, batch-to-batch variability, batch failures, and in turn lead to an increase in the cost of the product.
Therefore, it is essential that formulation scientists consider all three attributes of product development, being performance, stability and manufacturability, with equal importance.
Date and Location
Thurs Dec 6th, 2018
Registration & social hour: 5:30 PM
Seasons644 Pascack Road,
Washington Twp, NJ 07676
About the speaker
Dr. Simerdeep Singh Gupta is a Senior Scientist in Formulation Product Development at Teva Pharmaceuticals. Topical, transdermal and ophthalmic dosage forms are some of the products under his umbrella. Dr. Gupta previously worked as a Process Engineer at Teva, where he worked on the development of abuse deterrent, chewable controlled-release and vaginal drug products. Dr. Gupta worked as a Post-Doctoral Research Fellow at St. John’s University where he researched on the development of solid dispersions by hot melt extrusion.
Dr. Gupta has presented nationally and internationally, and is the recipient of several scientific awards at AAPS and NJPhAST conferences. Dr. Gupta’s research work has resulted in 10 peer-reviewed journal articles and 2 book chapters.
Dr. Gupta has been a passionate volunteer for several pharmaceutical organizations. He is currently serving as the NJPhAST Programming Committee Chair. Additionally, Dr. Gupta has served as the Sponsorship Chair for NJPhAST, Academic Outreach Committee member for NERDG, Organizing committee member for Jarowski Symposium, and Chair and Vice-Chair for AAPS student chapter at St. John’s University.
Dr. Gupta earned his Master’s degree in 2010 and Ph.D. in 2014 from St. John’s University.
Registered and paid online: $50.00
Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
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Note: in the event a meeting needs to be cancelled due to weather or other conditions, NJPhAST will do its best to notify all registrants as soon as possible; however, we ask that you exercise individual judgement if you do not hear directly from NJPhAST.