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Preparation and characterization of spherical agglomerates of gliclazide using novel carrier system

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Deepti K. Prabhakar, K. Kavitha2, Shankrayya M, N. Venuka Devi
» doi: 10.48047/ecb/2023.12.si4.1059

Abstract

Gliclazide is well established molecule and widely used for the management of type II diabetes. It exhibits very slight solubility in water, poor flow and compression characteristics. Hence directly compressible gliclazide-disintegrant agglomerates with improved water solubility, flow and compression characteristics for the enhancement of bioavailability Method: Gliclazide agglomerates were prepared by spherical crystallization technique using a three solvent system comprising acetone: dichloromethane (DCM): water (good solvent, bridging liquid and bad solvent, respectively). Poly vinyl pyrrolidine (PVP) in different concentrations were used as hydrophilic polymer. The effect of speed of rotation and amount of bridging liquid on spherical agglomeration were studied. The agglomerates were subjected to various physicochemical evaluations such as practical yield, drug content, particle size, porosity, IR spectroscopy, differential scanning calorimeter studies, scanning electron microscopy, micromeritic properties, solubility and dissolution studies. Results: The agglomerates showed improved micromeritic properties as well as dissolution behaviour in comparison to conventional drug crystals. The optimized agglomerates showed good sphericity as well as high drug release, and hence they were compressed into tablets by direct compression. The tablets were found within the limits with respect to various physicochemical parameters. The dissolution rate of prepared tablets was better than that of marketed tablet and pure drug. The optimized agglomerates and tablet formulations were found to be stable for 3 months under accelerated conditions. Conclusion: The optimized agglomerates exhibited good solubility, wettability, dissolution rate and other physicochemical properties compared to the pure drug

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