Thermal Characterization and Screening of Formulation Variables of Atorvastatin Calcium Immediate Release Tablet

In the present investigation, the compatibility of Atorvastatin calcium was evaluated with various superdisintegrants and other solid excipients by means of FT-IR and DSC. Several batches of tablets with varying proportion of superdisintegrants were prepared by direct compression techniques. Tablets were also evaluated for different physical properties and in-vitro drug release characteristics and optimized its release comparable to marketed innovator product. Various excipients used were sodium starch glycollate, Cross carmellose sodium, Cross-povidone, lactose, Micro crystalline cellulose, mannitol, sodium alurayl sulfate, magnesium stearate, and stearic acid. From the DSC studies, the excipients such as microcrystalline cellulose (Avicel 101), magnesium stearate, mannitol, Sodium lauryl sulfate were found to have physical interactions with Atovastatin. Immediate release tablet was prepared by direct compression method and its release profile was compared with the marketed IR tablet. The prepared tablet have conform the pharmacopoeial limit for hardness, thickness, friability, weight variation and content uniformity. Formulation F11 containing two super disintegrants have shown the disintegration time less than 25 sec and better dissolution than all other formulations releasing more than 80% of the drug after 20 minutes. Kinetic data reveals that the drug release follows best order by Higuchi model, followed by korsemeyer peppas, zero order and first order mechanisms. The results of accelerated stability studies as per ICH guidelines indicated that the tablet was stable as there were no any significant physical changes after the study.