FORMULATION DEVELOPMENT AND SOLUBILITY ENHANCEMENT OF ROSUVASTATIN CALCIUM TABLET PREPARED BY COMPLEXATION WITH β-CYCLODEXTRIN BY KNEADING METHOD

Rosuvastatin is a Dyslipidaemic agent, which acts by inhibiting HMG-CoA reductase enzyme and used in the treatment of hyperlipidemia. But Rosuvastatin calcium (RST) exhibit unsatisfactory dissolution profiles, problems of absorption and poor bioavailability. Thus objective of the study is to increase the solubility and dissolution rate of Rosuvastatin calcium (RST), a poorly water-soluble 3-hydroxy 3-methyl glutaryl CoA (HMG-CoA) Reductase inhibitor through inclusion Complexation with β-cyclodextrin (β-CD). Therefore the present investigation was to design a formulation of orally disintegrating tablets of Rosuvastatin. Orally disintegrating tablets of Rosuvastatin were formulated by superdisintegrants addition method by direct compression technique. Formulas prepared by direct compression showed good results, the prepared inclusion complex with β-CD by kneading method exhibited greatest enhancement in solubility and fastest dissolution (99.363 % RST release in 45 min, 102.22 % RST release in 50 min.) of RST. The inclusion complex contains RST: β-CD (1:1) was formulated into tablets using super disintegrants like sodium starch glycolate, crosspovidone and crosscarmellose. The prepared tablet were evaluated for various post compression parameters like hardness, friability, weight variation, thickness , drug content and in vitro dissolution.