New approaches to in vitro dissolution rate studies

Duygu YILMAZ USTA*°, Zeynep Şafak TEKSİN*

*Farmasötik Teknoloji Ana Bilim Dalı, Gazi Üniversitesi Eczacılık Fakültesi, 06330 Ankara, Türkiye

° Corresponding Author:
Phone: 0312 202 30 52
Fax: 0312 212 79 58
E-mail: yilmazduyguusta@gazi.edu.tr

Summary

The in vitro dissolution determines the quality and performance of the dosage form. The in vitro dissolution of the dosage form and the dissolution in biological fluids are the most important parameters affecting the absorption and bioavailability of the drug. The dissolution are evaluated in the reproducibility between the series, the post-approval formulation and the changes in the manufacturing process, and the biowaiver. Recently, biopharmaceutical evaluations based on Biopharmaceutical Classification System (BCS) related to dissolution rate and permeability as well as in vivo studies of drugs in vivo behavior, biorelevant media preferred in accordance with classical media, in silico approaches, simulations using pharmacokinetic models and in vitro in vivo correlations (IVIVC) have become very important. In this review, BCS-based subclassification approaches for in vitro dissolution rate studies, the use of biorelevant media and biopharmaceutical evaluations based on simulation have been evaluated.

Key Words :
In vitro dissolution, biorelevant media, simulation