Crystallization and Polymorphism-Scalable Process for Celecoxib and It’s Polymorph From-3 (Non- Steroidal Anti-Inflammatory Drug (NSAID)

Volume 2 - Issue 2

Krishnasarma Pathy* and MS Chakravarthy

Received: November 21, 2018;   Published: November 28, 2018

DOI: 10.32474/LOJMS.2018.02.000134

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Abstract

The present process provides an improved process for the preparation of 4-[5-(4-methylphenyl)-3- (trifluoromethyl)-1Hpyrazol- 1-yl] benzene sulfonamide (Celecoxib) and its purification and crystallization to produce polymorph. The present process, which describes the manufacturing process of Celecoxib, which is a non- steroidal anti-inflammatory drug (NSAID), has the advantage of scaling up to the industrial level of production. The process uses safe reagents in the process which makes it for industrial scale operations. The yields in the process are high, which makes it a cost-effective process. Formation of isomers are less compared with the all existing process, which makes it effective to make it to the pharmacopoeia grade. Residual solvents play a very important role in the impurity profile of APIs as per the ICH Guidelines ICH Q3C (R4). In this process by carrying out the final step of condensation in the aqueous medium followed by crystallization, the residual solvents limits are well taken care of.

Keywords: Non-steroidal anti-inflammatory drug (NSAID); Celecoxib; Cyclooxygenase 2; X-ray diffraction; Polymorphism; Process

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