Abstract

A REVIEW ON PROCESS VALIDATION OF EXTENDED RELEASE BI-LAYERED TABLET CONTAINING DAPAGLIFLOZIN, SITAGLIPTIN & METFORMIN HYDROCHLORIDE

Priya Kant*, Rita Saini and Shivanand Patil

Abstract

This article provides a detailed exploration of process validation of Dapagliflozin, Sitagliptin, and Metformin hydrochloride extended release bi-layered tablets, encompassing its introduction, life cycle, stages, and various types. The primary focus of the study is to demonstrate that process validation plays a pivotal role in instilling a high level of confidence that the products manufactured will consistently meet established specifications and quality attributes throughout the entire manufacturing process. Central to this confidence is the validation study, which rigorously evaluates critical parameters such as accuracy, sensitivity, specificity, and repeatability of the manufacturers approved and documented test procedures. Consequently, validation emerges as an essential component of quality assurance, ensuring that the products not only comply with regulatory requirements but also adhere to the highest standards of quality. The article further emphasizes the significance of employing objective measures, robust statistical tools, and thorough analyses in the validation process. These elements are crucial for understanding and managing variability, which is inherent in manufacturing processes. By focusing on the detection and control of such variability, process validation provides assurance of consistent quality and productivity throughout the product's life cycle. This review meticulously examines the different approaches, processes, and critical steps that must be continuously monitored during the manufacturing phase, highlighting the necessity of pharmaceutical validation. By addressing these various aspects, the article aims to reinforce the integral role of validation in maintaining product integrity, reliability, and compliance within the pharmaceutical industry, ultimately contributing to enhanced patient safety and therapeutic efficacy.

Keywords: Dapagliflozin, Sitagliptin, Metformin hydrochloride and Process validation.