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International Journal of Trends in Emerging Research and Development, 2026;4(3):156-160

Mechanistic Release Modelling, Dissolution-Profile Similarity and Accelerated Stability of an Optimised Metformin Matrix Tablet

Author : Anil Bajirao Jadhav and Dr. Umesh Kumar

Abstract

This paper examined the release mechanism, dissolution-profile similarity and short-term accelerated stability of an optimised 500 mg metformin hydrochloride matrix tablet containing guar gum and HPMC K100M. dissolution data collected over 12 hours were fitted to zero-order, first-order, Higuchi, Hixson-Crowell and Korsmeyer-Peppas models. The optimised tablet released 25.1, 50.4, 76.3 and 95.2% at 1, 4, 8 and 12 hours. The Korsmeyer-Peppas model provided the strongest fit (R² = 0.995) with a release exponent of 0.68, while the Higuchi model also fitted closely (R² = 0.991). The results indicated a substantial diffusion component together with polymer relaxation or erosion. Comparison with a marketed reference gave f1 = 1.1 and f2 = 83.4, indicating in vitro profile similarity under the represented conditions. During six months at 40 °C/75% RH, assay declined from 100.0 to 99.1%, friability increased from 0.50 to 0.55%, and 12-hour release changed from 95.2 to 94.4%. The constructed findings illustrate how kinetic modelling, model-independent profile comparison and stability testing can provide complementary evidence after formulation optimisation. They do not establish bioequivalence, therapeutic equivalence or shelf life.

Keywords

Accelerated stability, dissolution similarity, guar gum, HPMC K100M, Korsmeyer-Peppas, metformin hydrochloride, release kinetics