DEVELOPMENT OF ATORVASATIN 10MG IMMEDIATE RELEASE FILM COATED TABLET BY DIRECT COMPRESSION PROCESS

Atorvastatin is a commonly used drug worldwide. The present study aims on developing formulation of Atorvastatin 10 mg immediate release film coated tablet by direct compression process. Two formulations were developed containing dual diluents in same ratio (Lactose Anhydrous and Microcrystalline Cellulose), an alkalizing agent (Calcium Carbonate) as basic medium is required for dissolution of atorvastatin, a combination of super disintegrants (Croscarmellose Sodium and Low substituted Hydroxy Propyl Cellulose), a glidant (Colloidal Silicon Dioxide) and a lubricant (Magnesium Stearate). All excipients used in core tablet were of DC grade. Calcium Carbonate was taken as the variable as it is the most critical excipient in the designed formulation. One formulation contained 50 % Calcium Carbonate and other 25 % of the total core formulation. The diluents were accordingly used to adjust the quantity of Calcium Carbonate in the two formulations. Core tablets were coated using traditional film coating materials i.e. polymer (Hydroxy Propyl Methyl Cellulose), a plasticizer (Polyethylene Glycol) and an opacifier (Titanium Dioxide). Coating solvent used was Purified Water. Both formulations showed excellent flow properties. Core tablets were tested for weight variation, hardness, thickness, friability and disintegration whereas, assay and dissolution were tested for coated tablets. Dissolution was performed at multiple points in FDA official dissolution medium. Percent release and release pattern was compared with a reference innovator brand by using the model independent method, similarity (f2). The results revealed that both formulations show similarity in official dissolution media. Both formulations were also subjected to accelerated stability study at 40 ± 2°C and 75 ± 5% RH for 6 months and no specific change was observed.