Development & validation of level A: In-vitro and in-vivo correlation for ofloxacin using a systematic approach

Abstract

The key objective of the current research is to establish an IVIVC (in vitro and in vivo correlation) model for ofloxacin tablet formulations. The USP apparatus II is used to determine the in vitro drug release characteristics of drug, rpm ranging from 50-150, in a pH-varying medium. The in vitro dissolution testing is found to be applicable for calculating the in vivo drug concentration. Three different formulations are used for the study. The in vivo data is referred from the study aimed to assess bioequivalence of ofloxacin tablets. Plasma concentration is converted to cumulative percentages of drug absorbed using the Wagner-Nelson equation. The percentage in vitro cumulative drug dissolved, intercept, and slope are used to calculate the in vivo drug release. The cumulative drug release is plotted against the percent cumulative drug absorbed and the level A IVIVC model is developed using regression technique.