Menu

Student seminar- Polymorphism : A critical consideration in the pharmaceutical industry

by | Feb 14, 2024 | research | 0 comments

Student Seminar 

Name: Ms. Vijayata Kalidas Jagtap

Title- Polymorphism : A critical consideration in the pharmaceutical industry

Date & Time: Thursday, 15th February at 4.00 p.m. 

Venue: Rajarshi Bhattacharya Memorial Lecture Hall, Chemical Sciences Building

Abstract:  

About 50% of drug candidates that enter clinical trials fail due to efficacy and safety concerns, and the remaining 40% fizzle due to patent concerns and issues like solubility and drug interaction. Hence manipulating the desired physicochemical properties of a drug substance is of utmost importance during drug development. Improvements in physicochemical properties can be achieved by altering the physical forms of a given compound and these different crystalline forms of the same drug substance are called as polymorphs. The existence of polymorphism is inevitable, it unavoidably occurs during discovery, development, and manufacturing process, which indeed makes it a critical consideration in the pharmaceutical industry. Over the past two decades, the importance of pharmaceutical polymorphism has been arising in scientific community1 and industry as well as regulatory agencies. In this talk with the help of compelling case studies, the emphasis will be given on basics of polymorphism, types of polymorphism, relative thermodynamic stability relationship4, polymorph screening, application of diverse characterization tools1,3, significance and impact of polymorphism on drug substance as well as on a mankind2 – from a pharmaceutical perspective.

References:

  1. X. Yao, Rodger F. Henry, Geoff G. Z. Zhang. Ritonavir Form III: A New Polymorph After 24 Years. J. Pharm. Sci. 2023, 112, 237−242.
  2. Patricia C. Cruz, ́ Fernando A. Rocha, and Antonio M. Ferreira. Application of Selective Crystallization Methods To Isolate the Metastable Polymorphs of Paracetamol: A Review. Org. Process. Res. Dev. 2019, 23, 2592-2607
  3. Aline Quelian Penna Garbuio, Tássia Hanashiro , Blanca Elena Ortega Markman , Fernando Luiz Affonso Fonsec , Fábio Ferreira Perazzo , Paulo Cesar Pires Rosa. Evaluation and study of mebendazole polymorphs present in raw materials and tablets available in the Brazilian pharmaceutical market. Appl. Pharm. Sci. 2014, 4 (11),  001-007.

  4. Eun Hee Lee. A practical guide to pharmaceutical polymorph screening & selection. Asian J. Pharm. Sci. 2014, 9, 163-175