Volume 5

July-September 2013

Formulation and evaluation of atorvastatin calcium immediate release tablets-20 mg, USP

Kotta Kranthi Kumar, B Suma Padmaja, T Srikrishna

Abstract:  
Immediate release tablets are also tool for expanding markets, extending product life cycles and generating opportunities. The main aim of present research work was formulation development, optimization and in vitro evaluation of Atorvastatin calcium immediate release tablets. Preformulation studies and drug excipients compatibility studies were done initially and the results obtained direct the way and method of formulation. All the mentioned batches were done by wet granulation method. Tablets were evaluated for weight variation, thickness, hardness, friability, disintegration and dissolution. In vitro dissolutions were performed in dissolution media and the drug release in 0.05M phosphate buffer of pH 6.8 as medium revealed that the most successful formulation of the study and F9 exhibited satisfactory in-vitro drug release and (F1) and (F2) values were calculated. Dissolution profile of F9 was matched perfectly with marketed (innovator) formulation and F2 value was found to be excellent. Scale up of optimized formulation was done. The kinetic treatment showed that the optimized formulation follow first order kinetics and have good stability as per ICH guidelines.

Keywords: Atorvastatin, Lactose, Croscarmellose Sodium.