Design, Development and Evaluation of Metformin Hydrochloride and Glimepiride Immediate Release Tablets
M. Manikandan, K. Kannan, Subramanian Selvamuthukumar, Radhakrishnan Manavalan
Abstract
M. Manikandan, K. Kannan, Subramanian Selvamuthukumar, Radhakrishnan Manavalan
Abstract
Metformin hydrochloride is an insulin sensitizer and it acts by decreasing hepatic glucose production and intestinal absorption of glucose. Glimepiride acts as a secretagogue by reducing blood sugar by stimulating the release of insulin from pancreatic beta cells and by inducing increased activity of intracellular insulin receptors. The present investigation relates to the development and evaluation of immediate release tablets containing combination of Metformin hydrochloride and Glimepiride for the treatment of type II diabetes mellitus. The tablets were compressed using lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, crospovidone, magnesium stearate by wet granulation method. Povidone, hydroxypropyl cellulose methyl cellulose, talc, propylene glycol, polysorbate 80 and titanium dioxide were used for coating the compressed tablets. The fabricated tablets were evaluated for various pre-compression characteristics like bulk density, tapped density, compressibility index, Hausner's ratio, angle of repose and post compression characteristics like thickness, hardness, friability, weight variation, disintegration time and drug release. The results of the present investigation showed that, among all the formulations MGA08 was better in all the terms of pre compression and post compression parameters, prepared by wet granulation method. The most satisfactory formulation was stable during stability studies conducted for 90 days as per ICH guidelines. It showed no significant change in the physicochemical parameters and in vitro release pattern.
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Metformin hydrochloride is an insulin sensitizer and it acts by decreasing hepatic glucose production and intestinal absorption of glucose. Glimepiride acts as a secretagogue by reducing blood sugar by stimulating the release of insulin from pancreatic beta cells and by inducing increased activity of intracellular insulin receptors. The present investigation relates to the development and evaluation of immediate release tablets containing combination of Metformin hydrochloride and Glimepiride for the treatment of type II diabetes mellitus. The tablets were compressed using lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, crospovidone, magnesium stearate by wet granulation method. Povidone, hydroxypropyl cellulose methyl cellulose, talc, propylene glycol, polysorbate 80 and titanium dioxide were used for coating the compressed tablets. The fabricated tablets were evaluated for various pre-compression characteristics like bulk density, tapped density, compressibility index, Hausner's ratio, angle of repose and post compression characteristics like thickness, hardness, friability, weight variation, disintegration time and drug release. The results of the present investigation showed that, among all the formulations MGA08 was better in all the terms of pre compression and post compression parameters, prepared by wet granulation method. The most satisfactory formulation was stable during stability studies conducted for 90 days as per ICH guidelines. It showed no significant change in the physicochemical parameters and in vitro release pattern.
Key concepts: Glimepiride, Magnesium stearate, Granulation, Friability, Microcrystalline cellulose, Materials science, Polyvinyl alcohol, Dosage form