Abstract
FORMULATION DEVELOPMENT AND EVALUATION OF SITAGLIPTIN PHOSHPHATE

Milind P. Wagh*, Dhananjay M. Patwardhan and Rohit R. Patil

ABSTRACT

The purpose of this work was to formulate and evaluate target specific double coated orodispersible tablet for Sitagliptin Phosphate such that it should target specific sites of gastro intestinal tract like buccal cavity and intestine. To mask the bitter taste of API, sweetening agent saccharin sodium has been used by co-grinding and granulating method. Drug: Saccharin sodium was taken in 1:1 ratio. To achieve target specificity granules were coated with eudragit as an enteric coater followed by PVP as film coater thus targeting the DPP IV in intestine avoiding the drug release in stomach. The granules were mixed together as uncoated: Double coated in 1:2.68 ratio. Uncoated granules disintegrate rapidly in mouth as ODT while the sequentially coated granules release the drug in intestine. Formulation was optimized using 32 factorial design with Design Expert® Software version 10 to study the effect of independent variables, superdisintegrant crospovidone, (X1) and Sodium starch glycolate (X2). The formulated tablets were evaluated for hardness, disintegration time, wetting time, friability and In vitro drug release. An optimum tablet formulation (F-9), containing 45 mg of crospovidone and 40 mg of sodium starch glycolate, provides a short disintegration time of 18.00 seconds, sufficient hardness of 2.506 kg/cm2 and drug release in buccal cavity and intestine as 97.89% and 98.66% respectively. The results of this work suggested that ODT of Sitagliptin Phosphate with target specificity, rapid disintegration and fast drug release can be efficiently and successfully formulated.

Keywords: Sitagliptin Phosphate, Double coating, Target Specificity.


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