APV ASD Master Class | CN 6703
VenueAbbVie Deutschland GmbH & Co. KG
• amorphous systems and ASDs
• formulation, characterization, stability and bioavailability
• hands-on workshops on formulation and analytics
Workshop programme for download
In recent years the number of new chemical entities which arepoorly water soluble (BCS II and IV compounds), and for this reason poorly absorbed, has significantly increased. This confronts the pharmaceutical industry with enormous challenges for selecting adequate pharmaceutical formulations and manufacturing technologies which are suitable for all stages of research, development and manufacturing of such drug candidates, especially in the times of the Quality-by-Design (QbD) paradigm. One option to tackle this challenge is the development of an amorphous systems. The number of publications appearing in literature has shown that this field gained a lot of interest from researchers all over the world. Furthermore, in recent years a number of new launched products are using this formulation principle. This APV master class provides a systematic up-to-date approach of how to develop such systems from early stage of development up to launch.
Scientists and managers in pharmaceutical research and development, production, quality assurance,project management, product management and life cycle management.
In the first session of the master class we are setting the scene byproviding an introduction to amorphous systems and explaining the theoretical aspects for their stabilization. After comparing different amorphous systems, e.g. polymeric based, co-amorphous systems and mesoporous silica, we will gain a deeper understanding in predicting the miscibility of drugs in polymers from a thermodynamic standpoint. The session will be completed by presenting a structured development approach for amorphous systems.
The next session on formulation development and technology selection for amorphous solid dispersions will start with an overview of the different manufacturing technologies available for polymeric based amorphous systems. Subsequently, more detailed knowledge on formulation composition and process parameter selection will be shared for the two key technologies: hot melt extrusion and spray drying.
On the second day we will continue with a critical review of the stability of amorphous systems by looking into phase separation in liquid as well as in solid state and the effect water can have on the system. Furthermore, a number of advanced analytical tools for the characterization of these systems with particular focus on the physical nature of the drug substance in the system will be presented.
Later during the day, the knowledge gained so far can be consolidated in a roundtable discussions as well as in a workshop focusing on different analytical and formulation aspects.
Day three will continue with analytical methods, but this time with particular focus on the release mechanism of polymeric based amorphous solid dispersions. Furthermore, topics such as in-vivo-in-vitro correlation and biorelevant dissolution tests will be covered. As a continuation of the session on formulation development and technology selection from day 1 the focus in the second session of the day is on manufacturing technologies for co-amorphous systems and mesoporous silica as well as on downstream processing and continuous manufacturing of amorphous solid dispersions. Last but not least the conference will conclude with regulatory aspects and a quarter of a century experience of amorphous solid dispersions.