Development and Evaluation of Oro dispersible tablets of Rosuvastatin calcium By beta-Cyclodextrin inclusion complexes and using different Superdisintegrants
RESEARCH JOURNAL OF PHARMACEUTICAL BIOLOGICAL AND CHEMICAL SCIENCES(2017)
摘要
Rosuvastatin Calcium exhibit unsatisfactory dissolution profiles and, consequently, problems of absorption and poor bioavailability. Rosuvastatin Calcium (RST), a poorly water-soluble 3-hydroxy3-methyl glutaryl CoA (HMG-CoA) Reductase inhibitor through inclusion complexation with beta-cyclodextrin (beta-CD). The aim of this work was to develop Rosuvastatin Calcium Orodispersible tablets by exploiting the solubilizing effect of beta-cyclodextrin (beta-CD). Drug-CD complex systems, prepared by different techniques, Precipitation method, Kneading method, and Co-evaporation method, they were characterized by Fourier transform infrared (FT-IR) spectroscopy. The inclusion complex containing RST: beta-CD (1:1) was formulated into tablets using superdisintegrants like sodium starch glycolate, Crosspovidone and Crosscarmellose. Tablets containing RST- beta-CD inclusion complex were prepared by direct compression and evaluated for various post compression parameters like hardness, friability, weight variation, thickness, drug content and in-vitro dissolution. A significant improvement of the drug dissolution profile was achieved from tablets containing drug-CD systems Kneading method products showed the best dissolution profiles, reaching more than 97.05% drug release at the end of 30 min.
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关键词
Orodispersible tablets,beta-Cyclodextrin,inclusion complexes,Co-evaporation method,kneading method,Precipitation method,Rosuvastatin calcium
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