Abstract

ASSESSMENT ON DISSOLUTION TESTING AND CONTRASTING MODELS FOR DRUGS

Om Bagade?, Shashikant Dhole, Neha Nemlekar, Rohini Pujari, Amruta Shete, Priyanka Kharat

ABSTRACT

Over recent years, drug release from solid pharmaceutical dosage forms has been subject of intense and profile scientific developments. When a new solid dosage form is developed or produced, it is necessary to ensure that drug dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays on drug dissolution studies. In some cases, these mathematic models are derived from the theoretical analysis of the occurring process. The quantitative analysis of the values obtained in dissolution tests is easier when mathematical formulas that express the dissolution as a function of some of the dosage forms characteristics are used. Dissolution is the process by which a solid solute enters a solution. The dissolution rate was controlled by a layer of saturated solution that forms instantly around a solid particle. Dissolution is considered one of the most important quality control tests performed on pharmaceutical dosage forms and is now developing into a tool for predicting bioavailability, and in some cases, replacing clinical studies to determine bioequivalence. Dissolution behavior of drugs has a significant effect on their pharmacological activity. In-vitro dissolution kinetics provides useful information on the availability of drugs and their subsequent therapeutic effects In-vivo. Dissolution is good in understanding of the release mechanism of the dosage form as well as the physicochemical properties of the drugs. This review describes various methods and general techniques used in all dissolution.

Keywords: Dissolution, Drug Release, Models, Bioavailability, Bioequivalence.