Formulation and in-vitro Evaluation of Extended Release Metformin Hydrochloride Directly Compressible Tablets by Using ULTRAMODTM Polymer Premix

Abstract

Aims: Different types of drug release modifying polymers, their grades and quantities have to be optimised in the formulation considering solubility characteristics and biological half-life of the drugs. Further, formulations containing such discrete ingredients processed by conventional, multi-step manufacturing techniques can be a resource-intensive and challenging task for the formulators. This necessitated development of ready-to-use, co-processed polymer premixes. Methodology: Present study proposed to develop an optimised composition of a polymer premix, ULTRAMODTM and evaluate its performance in modifying release of highly water-soluble model drug (BCS Class III) having short biological half-life, metformin hydrochloride. Blend micromeritics and tablet physical properties and performance (in-vitro drug release) were evaluated by pharmacopeial methods. Results: Such formulations showed excellent flow and compressibility properties, tablet physical properties and drug release compared to the pharmacopeial specifications. These quality attributes and release modifying performance of the polymer premix stored at accelerated stability conditions for 6 months also was unchanged. Significance: The present research contributes to scientific formulation management by demonstrating how co-processed polymer premixes simplify extended-release tablet design, reduce formulation optimization trials, and enhance manufacturability. ULTRAMOD™ offers a scientifically robust and industrially scalable approach to developing matrix  tablets for highly water-soluble drugs, minimizing batch variability and reducing production cost and time. Conclusions: Ready-to-use, co-processed polymer premix proved to be an advantageous substitute to conventional polymers. This reduced formula optimisation challenges, manufacturing complexity and promises quick commercialisation.