Over more than the last two decades intense research was conducted in materials science aspects of small molecule drug substances and it is now well understood that the solid state form and the properties of the solid state form of an API play an important role in drug development and drug substance and drug product manufacturing.
The choice of the optimal crystalline form, polymorph, crystal size and or the choice of an amorphous forms determines both the performance of the drug product such as bioavailability or stability and the stability of the formulation process.
An early and substantial decision on the right form will facilitate and speed up the development process and help avoid late stage surprises and needs for late stage changes.
This process requires both a sound characterization of the properties of the moiety under consideration as well as a sound knowledge on the possibilities and limitations of engineering the particle properties and last but not least knowledge on the influence of the particle properties on the formulation behaviour as well as the capability to characterize these properties. Here the interplay of lab based and in silico data generation and interpretation will play a growing role to quickly and reliable decide on the solid form of a given API early in the pharmaceutical development process.
The conference will discuss all relevant aspects of this topic and recent advances in this field, focussing on pre-competitive aspects.
The presentations will discuss the current status and options of particle characterization and of particle design to meet the demands of formulation and the multitude of demands of modern formulations on the properties of the solid state form supplied.
A panelled discussion will be used to further the field and give input for further research.
KRISTALLISATIONSSYMPOSIUM 2015 – A better Route to optimzed Crysallization Processes and Product Quality
11. November 2015, Frankfurt am Main, MARITIM Hotel