Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability

Abstract

The present study was aimed to formulate and evaluate fast dissolving oral film of Rosuvastatin calcium to improve its bioavailability in comparison to typical solid oral dosage forms. The drug was formulated as solid dispersion with hydrophilic polymers and assessed for different constraints such as drug content, saturated solubility, and drug-polymer interaction. Best formula was selected and prepared in the form of orodispersible film. The films were developed by solvent casting method and examined for weight variations, drug content, folding endurance, pH, swelling profile, disintegration time, and in vitro dissolution. Further pharmacokinetic study was also performed on rabbit and compared with that of the marketed oral formulation. The drug and the polymers were found to be compatible with each other by FTIR study. Maximum solubility was found at drug polymer ratio of 1:4 and that was 54.53 ± 2.05 µg/mL. The disintegration time of the developed film was observed to be 10 ± 2.01 s, while release of the Rosuvastatin from the film was found to be 99.06 ± 0.40 in 10 min. Stability study shown that developed film was stable for three months. Further pharmacokinetic study revealed that developed orodispersible film had enhance oral bioavailability as compared to marketed product (Crestor® tablets). Conclusively, the study backs the development of a viable ODF of Rosuvastatin with better bioavailability.

Keywords

• Orodispersible film
• Rosuvastatin calcium
• Solvent casting method
• Pharmacokinetics