Enhancement of Solubilityand Dissolution Rate OfRosuvastatin Calcium By Complexation With Β-Cyclodextrin
The objective of the study was to increase the solubility, and dissolution rate of Rosuvastatin Calcium (RST), a poorly water-soluble 3-hydroxy3-methyl glut aryl CoA (HMG-CoA) Reductase inhibitor through inclusion complexation with β-cyclodextrin (β-CD).The phase solubility proﬁle indicated that the solubility of RosuvastatinCa was signiﬁcantly increased in the presence of β-CD and Apparent stability constant (KC) wasfound to be 42.003M-1. The inclusion complexes were prepared by three different methods viz. physical, kneading, Co-evaporation and precipitation method. The prepared complexes were characterized using FTIR, Differential scanning Calorimetry and Powder X-ray diffractometry. The inclusion complex prepared with β-CD by kneading method exhibited greatest enhancement in solubility and fastest dissolution (98.96% RST release in 30 min) of RST. The inclusion complex containing RST: β-CD (1:1) was formulated into tablets using superdisintegrants like sodium starch glycolate, Crosspovidoneand Crosscarmellose. The prepared tablet were evaluated for various post compression parameters like hardness, friability, weight variation, thickness, drug content and in-vitro dissolution. The stability of tablets was studied and no signiﬁcant changes were detected in the dissolution proﬁle of tablets after 1 month.