Abstract

OPTIMIZATION AND VALIDATION OF PROCESS FOR FORMULATION AND COATING OF RANITIDINE HYDROCHLORIDE TABLET

*Shruti Thakre ^a, Amit Bhople^b, Santosh Deshpande^b, Anup Thakre^c, Suyog Patil^d, Tabasubano Shekh^e

Abstract

Process validation is a requirement of the current Good Manufacturing Practices (cGMP) Regulations for Finished Pharmaceuticals. The FDA defines process validation as the establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristic. In this study, formulation and development of coated tablet containing drug Ranitidine which act as a histamine H2 receptor antagonist. Film coating was done using hydroxypropylmethylcellulose and ethyl cellulose. Infrared spectroscopy was done to evaluate interaction or incompatibility between drug and excipient. Optimization and validation of process for formulation and coating of Ranitidine hydrochloride tablets was done. The objectives of this study were to determine critical process parameters for tablet compression and coating operation, to establish boundary limits for critical process parameters which influence the product, process quality and performance and to evaluate compressed and coated tablets.

Keywords: Process validation; Optimization; Ranitidine; film coating.