Formulation Development and Evaluation of Ticagrelor Tablet for Regulatory Market.

ABSTRACT

The aim of the study was to develop a formulation of Ticagrelor 90 mg tablets that is equivalent to the reference product using similar excipients to match the in-vitro dissolution profile. A compressed coated tablet was formulated consisting of Ticagrelor and excipients conforming to the USP/BP monograph and below maximum amount allowed per unit dose. The physical characteristics of powder blends were evaluated for bulk density, tapped density, compressibility index, hausner ratio, angle of repose and moisture content. The compressed core and coated tablets were evaluated for thickness, hardness, weight variation, friability, disintegration, dissolution, drug content and stability. The powder blends for all formulations showed satisfactory bulk density, tapped density, compressibility index, hausner ratio, angle of repose and moisture content. All the core and coated tablets showed acceptable pharmaco-technical properties in terms of thickness, hardness, weight variation, friability, disintegration. Dissolution performances were varied depending on the composition of matrix tablet. Finally a formulation batch B05 consisting of Ticagrelor (34.61%), mannitol (61.15%), sodium starch glycolate (2.69%), hypromellose (HPMC-2910, 5cps) (0.77%), purified talc (0.38%), magnesium stearate (0.38%) and opadry grey (21k57558) (2%) showed maximum similarity with the reference product. Using this formulation a pharmaceutical will be able to met regulatory compliance.