IN VITRO DRUG DISSOLUTION AND DISSOLUTION TESTING APPROACHES: AN REVIEW

Ch. Taraka Ramaro*, N. Yarranna Reddy, P. Keerthi, V.Appalanaidu, V. Sravani

ABSTRACT

The contrasting views of dissolution testing taken by pharmaceutical scientists and regulators lead to constant development and review of the technology. The industrial drive is to improve the IVIVC, so speeding up the identification and development of new therapeutic products, whilst the regulatory focus is on the use of dissolution testing as a quality control tool to confirm product safety and efficacy. In vitro dissolution testing of solid dosage forms is the most frequently used biopharmaceutical test method in formulation development. It is used from the start of dosage form development and in all subsequent phases. Investigation of drug release mechanisms, especially for ER formulations obtaining a predefined target release profile and robust formulation properties regarding influences of physiological factors (e.g., pH and food) on the drug release. Generation of supportive data to bioavailability studies as an aid in interpretation of in vivo results. Validation of manufacturing processes. Investigation of effects of different storage conditions. Batch quality control (QC). A surrogate for bioequivalence studies. Drug release is determined by formulation factors such as disintegration/dissolution of formulation excipients or drug diffusion through the formulation. In vitro dissolution testing should thus provide predictions of both the drug release and the dissolution processes in vivo.

Keywords: Dissolution, Solubility, Paddle method, Basket method, Noyes Whitney eqn.