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Senthil Kumar Krishnan*, Pavan kumar, Dr.Mohammed Gulzar Ahmed


The objective of the research project is to enhance of the solubility of Glimepiride by using solid dispersion technique and the production of GMP tablets showing prolonged effect. The polymers used were β- Cyclodextrin (β-CD) and Poloxamer 188 (PLX-188) and solid dispersions were prepared by physical mixture (PHY) and Solvent evaporation (SE) method. Solid dispersions with different ratios 1:1, 1:3, 1:5 (using physical mixture and solvent evaporation method were prepared). The prepared solid dispersions were characterized by Physical appearance, FT-IR, % Drug content were evaluated. F1 to F19 tablet formulations were prepared by dry granulation technique, lactose monohydrate used as a filler, HPMC as a binder, ethyl alcohol used as a granulating agent, ethyl cellulose used as a granules coating polymer and each formulation GMP containing; a) GMP alone, b) GMP : β-CD (1:1, 1:3,1:5) PHY and SE, c) GMP : PLX-188 (1:1, 1:3,1:5) PHY and SE and, d) GMP: β-CD: PLX-188 (1:1:1, 1:2:2,1:3:3) PHY and SE. The solvent evaporation method showed more enhancement of GMP solubility than the Physical mixture. Finally, optimized coated granules were evaluated for their micromeritic properties such as true density, tapped density, Carr's index, and flow properties show satisfactory results. Tablet formulations were evaluated for various pharmaceutical characteristics viz. hardness, % friability, weight variation, drug content, in-vitro dissolution profiles. The dissolution results revealed that formulations F12 showed 96.15%, F15 showed 94.93% and F18 showed 97.67% of drug release at the end of 12 hrs. The drug release follows mixed order kinetics and the mechanism was found to be diffusion and non-fickian release. Based on the results of in-vitro and kinetics studies it was concluded that F12, F15 and F18 formulations shows sustained release action and solid dispersion technique by using β-CD and PLX-188 successfully used for enhancing the solubility of Glimepiride.

Keywords: Glimepiride, ?-Cyclodextrin (?-CD), Poloxamer 188 (PLX-188), Solid dispersion, Sustained release tablets.

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