The present study was planned to design an immediate release film coated tablet of atorvastatin calcium, which is used in cardiovascular diseases (CVD). CVD are the most prevalent cause of death and disability in both developed as well as developing countries. Atorvastatin calcium is BCS class II drug having low solubility and high permeability, it has less acid stability and produces lactone impurity in acidic media. Formulation of atorvastatin calcium immediate release tablet is planned to enhance acid stability and water solubility. Immediate release tablet of atorvastatin calcium was formulated by using different formulation approaches such as direct compression and wet granulation method by using rapid mix granulator. The excipients used in designed formulation are less in cost as compared to the marketed formulation. Drug is highly susceptible to moisture and at low pH environments; the objective of our study is to protect atorvastatin calcium from moisture and low pH environment. Film coating was applied to protect formulation from moisture by using OPADRY® white which contained hypermellose, polyethylene glycol, TiO2 and talc. Calcium carbonate was used in the designed formulation which acts as a stabilizer by neutralizing acidic pH environment hence it increases the acid stability of the formulation. Batch F6 formulation was found to be the best formulation which was prepared by the wet granulation method and it contains surfactant polysorbate 80 which has shown significant improvement in percent cumulative drug release. The batches F7 to F10 were formulated by using same formula and procedure used for batch F6 to check reproducibility of the formulation. The result obtained for batch F7 to F10 formula are found equivalent to batch F6 formula, which proves reproducibility of the formulation.
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