Original Articles: 2010 Vol: 2 Issue: 5
Formulation and stabilization of Atorvastatin tablets
Abstract
The present study is planned to develop Atorvastatin calcium amorphous into immediate release tablets. Pre-formulation study and drug excipients compatibility study was done initially and the results obtained were directs the way and method of formulation. Preformulation and drug excipient compatibility study, prototype formulation carried out for the highest dose of Atorvastatin calcium (80 mg) and optimized to get the final formula. Atorvastatin calcium (amorphous) is highly susceptible to hydrolysis and oxidation. So wet granulation method was avoided. All the mentioned batches were done by dry granulation method by roller compaction. Granules were evaluated for tests such as loss on drying (LOD), bulk density, tapped density, compressibility index and Hauser’s ratio and sieve analysis before compression. Tablets were tested for weight variation, thickness, hardness, friability and dissolution. In vitro dissolutions were performed and Formulation 1 (F1) and Formulation 2 (F2) values were calculated. Dissolution profile of F5 was matched perfectly with marketed (innovator) formulation and F2 value was found to be excellent. Also the impurity profile and stability result of F5 was found to be excellent. It can be concluded that the immediate release tablet was beneficial for delivering the drug which needs faster release to achieve the immediate action.