A key approach on dissolution of pharmaceutical dosage forms

Abstract

Dissolution testing is a critical methodology which is widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium, allowing it to dissolve over a specified period of time and then assaying the resultant solution using appropriate analytical method to determine the amount of drug. Dissolution tests are relevant for an array of investigations like drug degradation profiles, stability and shelf life studies, physical and mechanical testing of dosage forms, incoming QC testing on raw materials etc. The present review outlines the recent findings on various dissolution apparatuses, their modifications, methods for degassing of media like Helium sparging, Heating and filtering, Vacuum degassing, sonication and dissolution testing of various dosage forms like Immediate Release (IR) Dosage forms, Delayed Release Dosage Forms, Extended Release Dosage Forms, Transdermal Delivery Systems, Powders, Chewable Tablets, Buccal Tablets, Chewing Gums, Soft Gelatin Capsule, Aerosols, Suppositories and other Semisolids. This article presents, a short review on guidelines for dissolution profile testing, particularly focusing on the recommendations regarding statistical methods for assessing profile similarly. In this context, the guidelines on in vitro/in vivo correlations and on granting bio waivers are outlined briefly. The goal of this article is to give a survey of the current guidelines, including a description and discussion of the recommended methods for data analysis