Formulation Development of Sofosbuvir Film Coated Tablet

Abstract

Formulation Development is an important part of Drug Design and Development. Bioavailability and Bioequivalence are totally dependent on Formulation Development. Now-a-days Formulation Development is done by following QbD (Quality by Design). Here formulation development has also been done by following QbD. The purpose of this work is to develop a formulation of Sofosbuvir, which is an Anti-viral drug. It is used to treat Hepatitis C. As it is a fatal disease which damages the liver to an extent that one may die suffering from this disease. So development of a life saving drug was very much necessary for this disease. After treatment with Sovaldi (Innovator), a large amount of patients’ lives were saved and it turned out to be a miraculous drug. So this formulation was done to develop a drug to save the lives of the people of Bangladesh who are suffering from Hepatitis C at a much cheaper rate than the Innovator and also with an aim to give effect at an extent to Innovator as much as possible. Here a formulation of Sofosbuvir 400 mg Tablet was done where all the parameters (Hardness, water content, LOD, Disintegration Time, Dissolution and Assay) were found within expected limit. The found results are Hardness 28.8 Kp – 45.5 Kp (Limit: 20.0 Kp – 50.0 Kp), Water Content 2.24 % – 3.48 % (Limit: 1.00 % - 4.00 %), LOD 2.23 % - 3.35% (Limit: 1.00% - 4.00 %), Disintegration Time 0.67 minutes – 3.12 minutes (Limit: NMT 30 minutes), Dissolution 82 % - 102 % (Limit: NLT 75% (Q) in 45 minutes) and Assay 388.96 mg – 408.91 mg (Limit: 360.00 mg – 440 mg) in different stability conditions including initial condition.