Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) - Scientific guideline

This document describes a basic data package that is relevant to confirm the sound pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems.

Keywords: Solubilisation, surfactant, micelle, critical micelle concentration (c.m.c.), intravenous

Current version

Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems

Adopted Reference Number: EMA/CHMP/QWP/799402/2011 Legal effective date: 20/03/2012 Summary:

This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type.

Document history

Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems

Adopted Reference Number: EMA/CHMP/QWP/799402/2011 Legal effective date: 20/03/2012 Summary:

This paper describes a basic package of information which could be relevant to confirm the sound pharmaceutical development and full characterisation of products of this type.

Overview of comments received on ' Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) ' (EMA/CHMP...

Reference Number: EMA/CHMP/QWP/686808/2011

Draft reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)

Draft: consultation closed Consultation dates: 23/09/2010 to 31/12/2010 Reference Number: EMA/CHMP/QWP/574767/2010