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Taste Masking of Sitagliptin Phosphate Monohydrate By Ion Exchange Resin and Formulation of Rapidly-Disintegrating Tablets

Abstract

The purpose of this research was to mask the intensely unpleasant taste of Sitagliptin Phosphate Monohydrateand to formulate a rapid disintegrating tablet (RDT) of the taste-masked drug. Taste masking was done by complexing Sitagliptin Phosphate Monohydrate with Indion 414 in different ratios by the precipitation method. Drug-Resin complexes (DRCs) were tested for drug content, in vitro taste in simulated salivary fluid (SSF) of pH 6.2, and molecular property. Complex that did not release drug in SSF was considered taste-masked and selected for formulation RDTs. The complex with drug-Resin ratio of 1:1 & 1:2 did not show drug release in SSF; therefore, it was selected. The properties of tablets such as tensile strength, wetting time, water absorption ratio, in vitro disintegration time, and disintegration in the oral cavity were investigated to elucidate the wetting and disintegration characteristics of tablets. Crospovidone 8%wt/wt gave the minimum disintegration time. Tablets of batch F2 containing microcrystalline cellulose as Diluent Crospovidone showed faster disintegration, within 25 seconds. Good correlation between in vitro disintegration behavior and in the oral cavity was recognized. Whereas Sitagliptin Phosphate Monohydrate was rated intensely better with a score of 12 for 10 minutes. Tablets of batch F2 also revealed rapid drug release (t90, 7 minutes) in SGF. Thus, results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated tablets in the oral cavity.

K Surinder, SH Tusharkumar, RP Ezhilmuthu, and KL Senthilkumar

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