Formulation and Evaluation of Rosuvastatin Calcium Immediate Release Tablets Using Beta Cyclodextrin

Abstract

In order to treat Hyperlipidaemia, Rosuvastatin, a Dyslipidaemia drug, inhibits the HMG-CoA reductase enzyme. However, the calcium form of Rosuvastatin (RST) has low bioavailability, undesirable dissolving characteristics, and issues with absorption. Thus objective of the study is to increase the solubility and dissolution rate of Rosuvastatin calcium a poorly water-soluble 3-hydroxy 3-methyl glutaryl CoA (HMG-CoA) Reductase inhibitor through inclusion Complexation with β-cyclodextrin (β-CD). Therefore, the goal of the current study was to create a Rosuvastatin tablet formulation for oral dissolution. Rosuvastatin immediate tablets were developed using the direct compression showed good results, the prepared inclusion complex with β-CD by kneading method exhibited greatest enhancement in solubility and fastest dissolution (97.363) % RST release in 15 min. The inclusion complex contains RST: β-CD (1:1) and (1:2) was formulated into tablets using super disintegrants like Sodium starch glycolate, Cross povidone and Croscarmellose. All the mentioned batches were prepared and granules were evaluated for pre-compression parameters such as bulk density, tapped density and compressibility index. Tablets were evaluated for weight variation, thickness, hardness, friability; disintegration time and were found to be within the limits. In vitro dissolutions were carried out in 0.05M phosphate buffer with a pH of 6.8. The prepared tablet was evaluated for various post compression parameters like hardness, friability, weight variation, thickness, and in-vitro dissolution.