Technology Transfer and Process Validation of Metformin Hydrochloride Immediate Release Tablet

Abstract

Metformin Hydrochloride, inhibits the mitochondrial respiratory chain in the liver, leading to activation of AMPK, enhancing insulin sensitivity (via effects on fat metabolism) and lowering cAMP, thus reducing the expression of gluconeogenic enzymes. Metformin improves blood sugar levels by lowering the amount of glucose (sugar) that we absorb from our diet. It also helps stop the production of new glucose and improves insulin sensitivity. Metformin Hydrochloride is videly used in the form of sustained release formulation of Tablets. The study aimed to formulate and validate novel process for the Metformin Hydrochloride in immediate release pharmaceutical solid dosage forms. The wet granulation method used for formulation of Metformin Hydrochloride Immediate Release Tablets. Metformin Hydrochloride 500 mg, 850 mg, 1000 mg film coated tablets was prepared using FBE granulation technology on lab scale size. This study was carried out through a systematic plan; critical parameters were optimized to engender a stable & robust manufacturing process. The result of all three batches & its critical steps clearly shows consistency & reproducibility of parameters and all results. Hence the manufacturing method of Metformin Hydrochloride 500 mg, 850 mg, 1000 mg Film Coated tablets are validated at above parameters & equipments. Three validation batches of commercial scale batch size were taken successfully and monitored the in-process critical parameters for commercial batches. Metformin Hydrochloride tablets were manufactured within specified Limits for meeting all quality attributes and loaded for stability study. The overall successful three consecutive validation batches of Metformin Hydrochloride film coated tablets (500, 850 & 1000 mg) verifies the international technology transfer success.