Abstract

The current paper was an attempt to design a sustained release dosage form using various grades of hydrophilic polymers, Hypromellose (HPMC K15M, HPMC K100M and HPMC K200M) and Polyacrylate polymers, Eudragit RL100 and Eudragit RS100 with or without incorporating ethyl cellulose on a matrix controlled drug delivery system of Metformin hydrochloride. Methods: Laboratory scale batches of nine tablet formulations were prepared by wet granulation technique (Low shear). Micromeritic properties of the granules were evaluated prior to compression. Tablets were characterized as crushing strength, friability, weight variation, thickness, Drug content or assay and evaluated for in-vitro release pattern for 12 hr using Phosphate buffer of pH 6.8 at 37±0.5°C. The in-vitro release mechanism was evaluated by kinetic modelling. Results and discussion: The results obtained revealed that HPMC K200M at a concentration of 26% in formulation (F6) was able to sustain the drug release for 12 hours and followed Higuchi pattern quasi Fickian diffusion. With that combined effect of HPMC K15M as extragranular section and Eudragit RS100 displayed a significant role in drug release. Three production validation scale batches were designed based on lab scale best batch and charged for stability testing, parameters were within the limit of acceptance. There was no chemical interaction found between the drug and excipients during FT-IR and DSC study. Conclusion: Hence combinely HPMC K200M and Eudragit RS100 at a suitable concentration can effectively be used to sustain drug release

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