Current Edition

Generic Solid Oral Immediate Release Products in the EU – Regulatory Perspectives of Dissolution Specification

The development of a dissolution method with suitable specifications is a key part of any oral drug product control strategy. Dissolution testing is an in vitro technique of great importance in the formulation and development of pharmaceutical dosage forms, as it can be used as a substitute for in vivo studies under strictly defined and specified conditions. The main objective of the present study, according to C. Venkateswara Reddy et al. at JSS College of Pharmacy, is to know that the drug release rate is identical batch to batch.