Dissolution Method Development for Regulatory Approval: A Comprehensive Review and Case Study

In vitro dissolution testing is an important tool for any oral drug product. It is useful for product development and to ensure the in vivo performance of drug products throughout their commercial life without conducting clinical or bioequivalence studies after regulatory approval. It also plays a role in maintaining batch-to-batch consistency, providing quality assurance, supporting biowaiver and post-approval changes, etc. Guidelines from regulatory agencies provide expectations about the dissolution method and acceptance criteria; however, pharmaceutical manufacturers may fail to comply with the requirements or the expectations of the agencies, resulting in dissolution deficiencies. Furthermore, updates in dissolution testing may not be effectively communicated to non-industry scientists who are involved in dissolution or drug delivery research. This article provides a comprehensive review of the current American and European regulatory guidance for solid oral dosage forms followed by a case study to demonstrate how a dissolution method should be developed, which can be used as a framework for any drug product.