The EMA discussion paper is supposed to provide the information necessary for the development and complete characterisation of APIs that have been improved in their dissolubility through integrating them into micellar systems.
Especially since there are only a few test procedures that can adequately reflect the performance of such system following the integration, the authority calls for the development and validation of own methods - specifically for the clarification in vivo.
The paper also provides advice with regard to the critical micelle concentration of the surfactant, as well as to the capacity of such solubility conditioners and their stability respectively with regard to the need for clarifying these characteristics. It also refers to model studies supposed to contribute to the clarification of the in vivo performance.
You can find the discussion paper on the EMA Website. Entries can be submitted until 31 December 2010.
Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)