E. Vijay Kumar*, Kandukuri Sai1, K.S.Shoheb2, K. Usha Rani3, K. Supritha4
*Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P, India
1,2,3,4Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P, India
A B S T R A C T
In this present study, the tablets were prepared by using wet granulation technique. In order to optimize the product, different formulations were developed. All the formulations were evaluated for physical characteristics, Disintegration, in-vitro Dissolution and Stability studies. Based on the results of the above-mentioned tests Trial F – 08 was selected as the best formulation. Stability studies were performed for this batch for 1 and 3 months under accelerated and long-term testing conditions. Finally, after the duration, the product was analyzed for physical appearance, Hardness, Thickness, Friability, Loss on drying, disintegration, Assay and Related substance. The results obtained were found to be with in the specified limits. The bigger scale confirmatory batch is under 6 months Accelerated stability condition, based on the result, a pilot scale will be executed. After passing the above tests, the in-vivo studies (BA/BE Studies) will be executed to correlate the bioequivalence of best formulation (Trial F – 08) with the reference drug.
Keywords: drying, disintegration, Friability, in-vivo studies