Process Validation of Sitagliptin Film Coated Tablets 100 mg

Abstract

Introduction: Sitagliptin is an antidiabetic medication used to treat type-2 Diabetes Mellitus. As a member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class, Sitagliptin works by inhibiting the enzyme DPP-4, thereby increasing the levels of incretin hormones, which help regulate blood sugar levels. Process validation refers to the documented evidence that ensures the consistency and reliability of a manufacturing process that produces a product meeting predetermined specifications and quality attributes.

Objectives: This project is about the process validation of Sitagliptin film-coated tablets 100 mg, ensuring that the manufacturing process consistently produces a product of the highest quality, in compliance with regulatory requirements, and in line with industry standards.

Methods: The methodology outlines the steps for conducting the process validation study, from the formulation and manufacturing process to the analytical testing of the Sitagliptin Film-Coated Tablets 100 mg.

Results: Sampling of products performed at different stages of manufacturing, i.e., granulation, compression, coating & finished stage as per the validation protocol. The analytical test results assure that the manufacturing processes are well-validated.  

Conclusions: The process validation of Sitagliptin Film-Coated Tablet 100 mg, which had not been previously performed, was initiated through a novel approach. Process validation of the product Sitagliptin Film-Coated Tablet 100 mg to be carried out with three consecutive batches. During the process validation, critical process parameters and critical quality attributes were checked at the granulation, compression stage, and coating stage.