Formulation, Development and Evaluation of Rosuvastatin Calcium Immediate Release Tablets

The objective of the study was to increase the stability, and dissolution rate of Rosuvastatin Calcium, an acid labile antihyperlipedemic drug which acts as 3-hydroxy3-methyl glut aryl CoA (HMG-CoA) Reductase inhibitor through incorporation of different alkalizers. The different alkalizers used in the study are trisodium citrate, sodium bicarbonate, sodium alginate, di sodium hydrogen phosphate and meglumine. The tablets are prepared by direct compression and wet granulation method. The prepared tablets were evaluated for various post compression parameters like hardness, friability, weight variation, thickness, drug content and in-vitro dissolution. The results of the study revealed that the organic monovalent alkaliser meglumine shows the best results when compared with the innovator formulation. The dissolution studies showed that the drug release from all the formulation was complete and uniform in pH 6.6 sodium citrate buffer and T12 hardness (8.2 ±0.6) kp ,thickness(4.18 ±0.12)mm, friability (0.44)%, drug content uniformity (102±0.9)% and dissolution profile(99.5%) shows near to that of innovator and found to be the best formulation showing the drug release matched with that of innovator. The stability of tablets was studied at 40°C & 75%RH for period of 3 months at 40°C & 75% RH and no significant changes were detected in the hardness, friability, assay and dissolution profile of tablets after 3 month. The release kinetics studies performed and it follows the first order release kinetics and Peppas model indicates the mechanism of drug release i.e. Fickian diffusion. From the study it can be concluded that the formulation T12 can be considered as the optimized formulation. Key words: Anti hyper lipidemic, alkaliser, dissolution, stability.