FORMULATION DEVELOPMENT AND EVALUATION OF CARVEDILOL TABLET

The aim of the study was to develop a formulation of Carvedilol 25 mg tablet 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 Carvedilol and excipients conforming to the USP / BP monograph and below maximum amount allowed per unit dose. The powder blends for core and coated tablet were evaluated for bulk density, tapped density, moisture content and pass through mesh #100. The compressed core and coated tablets were evaluated for thickness, hardness, average weight and friability, loss of drying, disintegration, dissolution, drug content and stability. The powder blends for all formulations showed satisfactory bulk density, tapped density, moisture content and pass through mesh #100. All the core and coated tablets showed acceptable pharmaco-technical properties in terms of thickness, hardness, weight variation, friability, loss of drying and disintegration. Dissolution performances were varied depending on the composition of formulated tablet. Finally a formulation batch B09 consisting of Carvedilol (14.28 %), Colloidal Silicon Dioxide (1.3 %), Lactose Monohydrate (60.79 %), Microcrystalline Cellulose (10.29 %), Sucrose (10.29 %), Crospovidone (1.51 %), Magnesium Stearate (1.54 %) and Opadry II (2.9 %) showed maximum similarity with the reference product. Using this formulation a pharmaceutical will be able to met regulatory compliance