Abstract

“FORMULATION, DEVELOPMENT AND EVALUATION OF ATORVASTATIN, ASPIRIN AND CLOPIDOGREL TABLETS IN CAPSULES FORM”

R. Margret Chandira*, P. Palanisamy, B. Jaykar, A. Pasupathi, B. S. Venkateshwarlu

Abstract

The present work was done to formulat ion, development and evaluation of immediate release tablets of Atorvastatin calcium, Clopidogrel bisulphate and delayed release tablet of Aspirin in a capsule. The Aspirin and Clopidogrel bisulphate used as anti-platelate agent and Atorvastatin calcium is HMG Co-A reductase inhibitor which lowers the plasma concentration of cholesterol. The combination of drugs used in Chronotheraphy. The tablets were prepared by direct compression method. The pure drug and granules were evaluated for angle or repose, bulk density, tapped density, compressibility index, Hausner‟s ratio and characterized by FT-IR, DSC spectrum were evaluated. Immediate release Atorvastatin calcium and Clopidogrel bisulphate was prepared and using different concentration of Croscarmellose sodium and Crospovidone superdisintegrant by direct compression method. Delayed release Aspirin were prepared direct compression method. Atorvastatin calcium, Clopidogrel bisulphate were substituted for aqueous film coating to mask the spotting from both drugs and protection from light. Aspirin were substituted for enteric coating to mask the gastric problem in acid pH. The tablets coating as to avoid any interaction with three drugs. The core and coated tablets were subjected to weight variations, diameter, thickness, hardness, friability, disintegration time, drug content by assay and in-vitro dissolution studies were evaluated. All the tablet formulations showed acceptable pharmaceutical properties. From dissolution profile of ATF7 Atorvastatin calcium gives the release within 30 minutes required value i.e - 103.12% respectively. CLT7 Clopidogrel bisulphate gives the release within 30 minutes required value i.e – 102.14% respectively. AT4 Aspirin gives the release with 2 hrs required value I,e – 104.21% respectively. The optimized formulations showed the f2 (f2=64, 62 & 65) values. The similarity factor f2 was applied between the optimized formulations and the theoretical dissolution profile. The result of stability studies of batch ATF7, CT7 and AT4 indicate that it is stable at 40°C / 75% ± 0.5 % relative humidity as there was no significant differences observe for physical, weight variations, diameter, thickness, hardness, friability, disintegration time, drug content by assay and in-vitro dissolution studies were evaluated. The formulations were found to be stable for after 3 months of accelerated stability studies.

Keywords: Atorvastatin calcium, Aspirin, Clopidogrel bisulphate, Chronotheraphy.