FORMULATION AND EVALUATION OF FAST DISSOLVING BUCCAL FILM CONTANING DABIGATRAN ETEXILATE

Pooja K. G. and Kopparam Manjunath*

ABSTRACT

The main aim of this research is to improve the bio-availability of a drug Dabigatran etexilate by formulating and evaluating the fast dissolving buccal film containing Dabigatran etexilate, that helps to avoid the first pass metabolism easy compliance for patient and it is easy for administration. Dabigatran etexilate is anticoagulant that used to treat deep vein thrombosis, pulmonary embolism. Buccal films were prepared by solvent casting method by using different polymers alone and combination, Polymers like HPMC E 15, PVA, PVP K30, glycerine acts as plasticizer, saccharin acts as sweetening agent, sodium citrate acts as saliva stimulating agent, vanillin acts as flavouring agent. FTIR studies shows that there is no interaction between drug and polymer. By using calibration curve method find out the % of drug release, dissolution profile were studied by using dissolution apparatus USP type-2 by using phosphate buffer of 6.8 pH. The prepared buccal film were evaluated by folding endurance test, film thickness test, disintegration test, weight uniformity test, stability studies and in-vitro drug release. Among all the formulation F3 was selected as best formulation based on evaluation and in-vitro drug release studies.

Keywords: Dabigatran etexilate, HPMC E-15, PVA, PVP K30.