Optimizing Freeze Dried Drug Dosage Form to Treat Muscle Atrophy

Using a SP Scientific LyoStar Freeze Drying System - leading pharmaceutical process development experts - GILYOS GmbH will participate in a research program called "FORMOsA*" which was recently funded with about two million euros by the German Bavarian Research Foundation. The project focuses on age-related muscle atrophy (sarcopenia).

In this project, GILYOS will be actively involved in the formulation development and freeze drying process design and optimization of follistatin for subcutaneous application. Follistatin is a messenger substance which is present in almost all types of tissue. The protein effectively inhibits myostatin which, in turn, plays a key role in skeletal muscle atrophy. Follistatin might therefore be a promising substance for treating sarcopenia.

To optimize the freeze dried dosage form, GILYOS will use the Lyostar Freeze Drying system to investigate partially crystalline formulations as such mixtures allow short process times which are of great economical interest.

The SP Scientific LyoStar3 is a state-of-the-art freeze-dryer that provides unmatched process accuracy, reliability and unique ease-of-use features. For applications ranging from process development for scale-up to product processing for stability studies to formulations work the LyoStar delivers consistent results other freeze dryers cannot match. The LyoStar features RTD-controlled shelf temperature accuracy of +/- 0.5°C or better and vacuum control within 0.1% of set-point. Its robust 5.5 hp cascade refrigeration system enables shelf pull down from ambient to –40°C in less than 25 minutes, and the ultra-reliable scroll compressors feature just 3 moving parts. Available with ControLyo Nucleation On-demand Technology, the LyoStar 3 provides R&D and Process Development Scientists with precise control over their freeze-drying processes.