Development and validation of In Vitro In Vivo Correlations for the developed modified release formulations of selected drug candidates

Abstract

This thesis deals with the studies carried out by the writer three years on the Development and validation of in vitro-in vivo correlations for some modified release formulations . Thesis begins with a brief account of the in vitro - in vivo correlations, biopharmaceutical classification systems, IVIVC models, in vitro dissolutions and estimation of drugs in biological medium. The methods used for the IVIVC model development, validation, the steps involved in bio analytical method development, in vitro dissolution methods and their importance have also been discussed. A review of literature on IVIVC model development available for the drugs in biological fluids is presented. The scope and objective of the present investigation. The merits of IVIVC in the development of dosage forms and how IVIVC model development necessitates development of in vitro dissolution methods, bio analytical method development and validation are discussed. The objectives of the study, namely, to develop and validate the methods to estimate the selected drugs in the biological fluids by HPLC, development of in vitro dissolution methods and IVIVC model development and validation have been described. Thesis also deals with the experimental procedures adopted. It describes in detail the procedures adopted for the bioequivalence study design and data handling, optimization and validation of the chromatographic conditions for the estimation of the drugs in plasma and selected modifies release (MR) formulations, IVIVC model development and validation. The results obtained are presented, supported by tables and figures and discussed in detail. In conclusion, it may be pointed out that the developed in vitro dissolution methods can replace absorption studies during the pre-approval process to develop a desirable formulation and to ensure batch-to-batch bioequivalence. It will also be very useful in performing possible post-approval changes in the formulation scale up or changes in the drug substance or excipients supplier. newline