Regulatory aspects of drug dissolution from a European perspective.

The need for an early identification of formulation and manufacturing factors that are important for setting satisfactory specification limits for the dissolution rate of an active substance from a dosage form is emphasized. A discriminatory dissolution test has to be developed based on experiences from early drug development, bioavailability/bioequivalence studies and clinical trials. References are given to guidelines of the EU-system and to the monographs and chapters of the European Pharmacopoeia, which have to be considered. The dissolution test is expected to be an appropriate tool for checking that the manufacture of dosage forms is consistent and successful and that each dosage unit of a batch will have pharmaceutical qualities that correspond to those on which the safety and efficacy documentation of a product is based.