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

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

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

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

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 closedConsultation dates: 23/09/2010 to 31/12/2010Reference Number: EMA/CHMP/QWP/574767/2010