Another substantial build for Seda’s lab capability with the installation of Distek’s 2,500 dissolution bath.
Dissolution is one of the most important and emotive test employed during the development and testing of drug products.
Development dissolution tests should be used to inform on the likely clinical performance of prototype drug products and choose the formulation approach and composition most likely give the required exposure in patients.
As development moves into later phases, dissolution focus moves towards ensuring reproducible manufacture and product quality, and dissolution becomes a key specification to agree with regulatory authorities.
Linking understanding of both clinical performance and product quality / manufacturing control into a single test can bring many benefits (clinically relevant specifications) and can bring many benefits to the sponsor.