Design and Development of Fast-dissolving Tablets of Apixaban using Single Coprocessed Excipient

Abstract

Background: Apixaban is administered orally as an anticoagulant action and minimizes the chances of strokes and systemic embolism. The conventional film-coated tablet showed less bioavailability due to its minimal solubility in the gastrointestinal tract.  Rationale: The goal of designing the current analysis is to prepare a prompt release tablet using a single Coprocessed excipient which minimizes multistep processing, time, and cost effectiveness. Methods: The prompt release tablets of Apixaban were developed by direct compression technique using multifunctional material like Prosolve ODT G2 and Prosolve Easytab. Drug excipients inertness was confirmed with FTIR and DSC. Flowing characteristics of Apixaban and co-processed excipients were evaluated in terms of Carr’s index, Angle of repose, and Hausner’s ratio. These co-processed excipients indicated exceptional flowing and compression characteristics. The ready tablets were assessed for weight variation, hardness, friability, dispersion time, disintegration, and dissolution studies. Results: Among 12 batches, the least disintegration time was shown with C6 with a cumulative drug release of 99.06 % within 25 min. The optimized batch C6 was highly stable when tested under stability guidelines at 40 0 C and at 75 % relative humidity.   Conclusion: Among these co-processed excipients, Prosolve Easytab SP was found the best one for direct compression intended for the immediate or fast dissolving tablets.