Online ISSN: 2515-8260

FORMULATION AND EVALUATION OF DABIGATRAN RAPID DISSOLVING TABLETS WITH POLYPLASDONE XL-10 AND PRIMELLOSE

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T Naga Aparna * , V Durga Madhuri , Varun Dasari , Perli Kranti Kumar

Abstract

ABSTRACT Dabigatran is an oral anticoagulant drug requiring rapid onset of action to exert desired pharmacological effect. It is a lipophilic (BCS Class-II) with little/no aqueous solubility, its absorption is dissolution rate limited. Increase in solubility of the drug is required to get rapid action. It has the half life of 14 hours and bioavailability in the body is 65% due to first pass metabolism. The purpose of this investigation is to develop fast dissolvimg tablet of Dabigatran to improve oral bioavailability for its immediate action for the treatment of stroke prevention in atrial fibrillation, the fast dissolving tablet was formulated by wet granulation technique using hydrophilic carrier like PEG-400 as solubilizer and POLYPLASDONE XL-10 and PRIMELLOSE used as super-disintegrant. The pre and post compression parameters were evaluated. From the dissolution profile it was concluded the tablet prepared by wet granulation technique, the formulationF6 containing 4% of PEG 4000 and 7.5% PRIMELLOSE showed 85.46% drug release due to its increase in porosity and wettability. From the DSC and FTIR study it was concluded that there was no possible drug and polymer interactions.

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