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 (Wuerzburg, Germany) 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 optimise 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.

SP Scientific (www.spscientific.com) is a leading manufacturer of laboratory-to-production scale freeze dryers / lyophilizers, centrifugal evaporators and concentrators, thermal management system and glassware washers. The company sells its products under well-known brands including Hull, VirTis®, FTS Systems™, Genevac®, and National- Hotpack®. SP Scientific has ISO 9001:2008 registered production facilities in the USA and Europe.

GILYOS GmbH (www.gilyos.com) is a research-oriented contract service company specialising in the field of freeze-drying (lyophilization) for the pharmaceutical and food industry. The company combines top-notch, innovative academic research with targeted and straight forward contract development services. GILYOS has a profound expert knowledgebase in the field of formulation design for pharmaceuticals and biologicals, physicochemical examination of materials, freeze-drying cycle development, process optimization and subsequent scale-up to manufacturing. The company uses cutting-edge analytical methods to fully characterize drug formulations (liquid and solid state), with special focus on predictability of product behavior during the process and long-term storage. One of their key-competences is implementation of process analytical technology (PAT) in freeze-drying and the establishment of Quality-by-Design (QbD) concepts.

For further information on the Lyostar Freeze Drying System please contact SP Scientific on +1-845-255-5000 (+44-1473-240000 in Europe) or email shireen.scott@spscientific.com. For further information on Freeze Drying contract research services please contact GILYOS on email: info@gilyos.com.

* Project “FORMOsA: muscle atrophy (sarcopenia) and osteoporosis- consequences of limited old-age regeneration” was recently funded with about two million euros by the German Bavarian Research Foundation. The project involves leading research groups in this area from three different universities and selected industrial partners located in Bavaria to develop new preventative measures and therapies for sarcopenia.  Muscle atrophy (sarcopenia) is one of the most common health problems in the elderly and can severely impact their mobility. More than 20 percent of people over 65 and more than 80 percent of all those in need of care and over the age of 80 are affected by loss of muscular functionality – this means approximately 50 million people worldwide. The patients often require assistance or even intensive care.

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