Development and Evaluation of Orodispersible Tablets of Rosuvastatin Calcium-hp-β-cd Inclusion Complex by Using Different Superdisintegrants

Commercial tablets of Rosuvastatin Calcium exhibit unsatisfactory dissolution profiles and, consequently, problems of absorption and poor bioavailability. Rosuvastatin Calcium (RST), a poorly water-soluble 3-hydroxy3-methyl glut aryl CoA (HMG-CoA) Reductase inhibitor through inclusion complexation with hydroxy propyl β-cyclodextrin (HP-β-CD). The aim of this work was to develop Rosuvastatin Orodispersible tablets by exploiting the solubilizing effect of hydroxy propyl β-cyclodextrin (HP-β-CD). Drug–CD complex systems, prepared by different techniques, were characterized by differential scanning Calorimetry (DSC), X-ray diffractometry, and Fourier transform infra-red (FT-IR) spectroscopy. The inclusion complex containing RST: HP-β-CD (1:1) was formulated into tablets using superdisintegrants like sodium starch glycolate, Crosspovidone and Crosscarmellose. Tablets containing RST-HP-β-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 (Kneaded products showed the best dissolution profiles, reaching more than 97.46% drug release in 20 min.). The stability of tablets was studied and no significant changes were detected in the dissolution profile of tablets after 1 month.