Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations.

The article explores the legislative framework of alcohol-induced dose dumping (ADD) for modified-release formulations. Topics discussed include revolutionalization in the delivery of active pharmaceutical ingredient APIs using modified-release (MR) systems, use of polymer matrix or by a polymer film coating for controlling drug release and need for harmonization of the U.S Food & Drug Administration FDA and European Medicines Agency EMA guidelines concerning ADD in-vitro testing conditions.