Design optimization and evaluatıon of polyvinyl alcohol based oral thin film of apixaban

Abstract

The current research work aimed to prepare an optimized and evaluate fast-dissolving oral thin film of Apixaban using polyvinyl alcohol as a film former. The oral thin film of Apixaban enhances the solubility, bioavailability, and therapeutic efficacy in thrombus, pulmonary embolism, and venous thromboembolism. The chemical compatibility and thermal analysis were investigated with the help of FTIR, and DSC. The optimization was performed with the Box-Behnken design. The concentrations of film former (PVA: X1), plasticizer (PEG 200: X2), and superdisintegrant (cross povidone: X3) were considered as independent factors and the critical quality attributes for the oral films are disintegration time, dissolution, and folding endurance. The ANOVA comprised of Quadratic model which predicted p-values of 0.0039, 0.0105, and 0.0020 significant. The scanning electron microscopy assessed the texture of the film. An optimized batch P6 disintegrated within 19 seconds, released the drug (99.07 %) within 10 min and had a folding endurance of 116. The results conclude that optimized batch P6 of oral thin film of Apixaban significantly minimizes the deep vein thrombosis, pulmonary embolism, and venous thromboembolism due to fastest onset of action and improved solubility. Thus, the complications associated with the clotting of blood is sharply reduces.

Keywords

• Oral thin film
• Apixaban
• Polyvinyl alcohol
• Deep vein thrombosis
• Box-Behnken design

References

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