Formulation And Evaluation Of Daclatasvir Immediate Release Tablet

Abstract

The major work was to formulate an immediate release tablet formulation with daclatasvir employing the use of superdisintegrants, fillers, binder and lubricants at varying concentrations using wet granulation method for tablet preparation. Immediate release tablet were made by changing the concentrations each excipient to come up with the best formulation among all of them.

In the current study, a total of 6 formulations were prepared by changing the concentration of the excipients at the various stage of the formulation such as during dry mixing, granulation and lubricating phase. Up to formulation F4 the use of super disintegrants in combination and without combination, during the dry mixing phase, showed poor drug release, but after addition of super disintegrants starting from formulation F5 to F6 in the lubrication phase also, showed improvement in drug release. The pre-compression parameters for all the formulations were found to be within acceptable range.

Thus, based on the post-compression evaluation parameters, the formulation F6 containing Croscarmellose sodium 4% w/w & Crospovidone CLF 2.5% w/w in the dry mixing phase and additional Croscarmellose sodium 5% w/w in the lubrication phase showed a drug release of more than 85% at 30 minute time interval.