FORMULATION AND EVALUATION OF FIXED DOSE COMBINATION OF ATORVASTATIN CALCIUM AND AMLODIPINE BESYLATE IMMEDIATE RELEASE FILM-COATED TABLETSAbstract
The present research work was envisaged to develop immediate release film-coated tablets of a fixed-dose combination of Atorvastatin calcium and Amlodipine besylate used to treat the hyperlipidemia, angina pectoris, atherosclerosis, hypertension and symptoms of cardiac risk. Additionally, fixed-dose combination therapy of both drugs tends to provide a synergetic effect and reduce the pill burden. Immediate-release tablets are mostly recommended for fast upgrading drug delivery systems, and thus, an effort was made to improve the onset of action of the drug. The concept of formulating immediate-release tablets using superdisintegrants like CCS offers a suitable and practical approach to faster disintegration and dissolution characteristics. In the current investigation two methods were adopted namely direct compression and wet granulation for formulation development. Based on the drug content and dissolution results, the direct compression method was used for further study. The prepared dosage forms were also subjected to pre and post compression evaluations. The results of in-vitro drug release suggested that CF6 was the ideal formulation among all the other formulations. In-vitro drug release ATO (101.4%) and AMLO (100.3%) obtained within 30 min. The optimum concentration of superdisintegrant (CCS) was found to be 4.2% w/w in CF6 with disintegration time 21 sec. The best formulation (CF6) was made to undergo kinetic analysis followed by stability studies and shelf-life determination, which was found to be 22 months. For the protection of sensitive the drug from an external environment, the film coating method was also applied to ensure the stability of the developed formulation.