The Significance of Disintegration Testing in Pharmaceutical Development

Disintegration is a physical process related to the mechanical breakdown of a tablet or granulate particle into smaller particles. This review investigates disintegration mechanisms, pharmacopeial use of the disintegration test and scientific studies showing its utility and potential as a pharmaceutical performance test. With a proper dosage form understanding and demonstration/justification of the mechanistic details of drug dissolution from a dosage form, dissolution testing might be replaced by disintegration testing as a performance test. However, more research is needed to make disintegration test results more mechanistically valuable in pharmaceutical development. This might lead to a reliable performance test and potentially an in-vivo predictive disintegration test in the future.