The Fundamentals of Dissolution Testing

Abstract

In this article, experts discuss the fundamentals of dissolution testing and highlight the challenges that are surfacing as a result of the increasing numbers of poorly soluble molecules entering the development pipeline. Because oral solid dosage forms are still the most common way in which drugs are administered, dissolution of the dosage form after it is swallowed, namely the rate at which the active ingredient is released into the body, is a critical facet of drug development. [...]previous 'fringe' techniques such as intrinsic dissolution, small-volume dissolution, and dissolutions using enhancer, immersion, or extraction cells are becoming more widely adopted." In European Pharmacopoeia section 2.9.3 (4), developers can find information on apparatus, procedures, and evaluations for acceptance criteria also. "Since 2014, Europe has also started following the USP approach of publishing individual formulation monographs containing dissolution methods and acceptance criteria," adds Eckert. "The use of dissolution data in IVIVC approaches is also explained in EMA's guideline (6) on the pharmacokinetic and clinical evaluation of modified release dosage forms." Because dissolution testing is fundamental for the assessment of the performance of oral formulations and is widely used around the world, much work has been done to create a globally uniform approach.