Formulation and Evaluation of Fast Dissolving Tablets of Atorvastatin Calcium using Starch Malonate

Abstract

Fast dissolving tablets containing Atorvastatin calcium were prepared using the direct compression method with various superdisintegrants and evaluated for hardness, friability, weight variation, disintegration time, wetting time, and in vitro drug release. The precompression characteristics indicated good flow properties and compressibility of the drug with the excipients. Post-compression evaluations showed uniform hardness, thickness, and diameter across all tablets, ensuring uniform size, shape, and good resistance to mechanical damage. The weight variation of all formulations was within prescribed limits. The FDTs containing Starch Malonate demonstrated rapid disintegration and dissolution, with formulation F3 showing a disintegration time of 21 seconds, outperforming formulations with crosspovidone and croscarmellose sodium. Increased concentrations of Starch Malonate, crosspovidone, and CCS corresponded with decreased disintegration times. Starch Malonate exhibited the fastest wetting time, followed by crosspovidone and CCS, underscoring its superior disintegration power. The wetting time correlated with disintegration time in the oral cavity, highlighting the disintegrants' capacity to swell in minimal water. In vitro studies indicated rapid drug dissolution within 10 minutes, attributed to the quick breakdown of particles and rapid drug absorption into the dissolution medium. In conclusion, incorporating Starch Malonate as a superdisintegrant in Atorvastatin Calcium FDTs effectively promoted rapid disintegration and drug release, offering potential advantages in patient convenience and compliance, especially for those with swallowing difficulties or preferences for orally disintegrating dosage forms.