FORMULATION AND EVALUATION OF SUBLINGUAL FILMS OF APIXABAN

Abstract

The concept of sublingual film dosage form has become popular as new delivery system. This system will provide maximum therapeutic efficacy, increased bioavailability and maximum stability by reducing the frequency of dosage. It will also avoid first pass metabolism of the drugs. This system provides more rapid drug absorption from the pre gastric area which may provide quick onset of action. The present research aimed to prepare sublingual films of apixaban reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The film was prepared using solvent casting method and optimized employing 32 factorial design considering two independent variables film forming polymer (HPMC E5) and PEG 400. Disintegration time, drug release and folding endurance were taken as dependent variables. The prepared optimized formulation showed minimum disintegration time (35 s), highest dissolution rate (99 %) and satisfactory physicochemical properties. It is evident from the above results that the developed formulation can be an innovative dosage form to improve the drug delivery, onset of action as well as improve patient compliance. Key Words: Apixaban, Sublingual films, HPMC