Optimizing similarity factor of in vitro drug release profile for development of early stage formulation of drug using linear regression model

Abstract

Abstract The objective of this article is to optimize the similarity factor within immediate release (IR) and modified release (MR) of in vitro drug release profiles. The least square method is used to minimize the difference between empirical and regression curve fitting data of in vitro IR/MR drug release profiles. An estimation of percentage drug release at intermediate timepoints has been done to improve the similarity factor f 2 $f_{2}$ using linear curve fit method. In this study linear regression model is used to analyze the similarity factor f 2 $f_{2}$ for Nitrofurantoin MR Capsules, Venlafaxine HCl MR Tablets and Lurasidone IR Tablets in order to exhibit the significance as well as similarity owing to the consideration of extra intervening timepoints. This linear regression model may help pharmaceutical industries to examine the inside comparison of IR/MR in vitro drug release profile with few modifications in timepoint selection to improve similarity factor f 2 $f_{2}$ .

Keywords

• Drug release profiles
• Similarity factor f 2 $f_{2}$
• Linear regression model
• Least square method