Prosonix has announced the successful scale up of UMAX, its new particle engineering technology that is set to revolutionize respiratory medicine. The scaleup has now been demonstrated on multiple APIs in GMP facilities.
Prosonix and its partners have shown a seamless transition from laboratory to commercial scale batches, with no loss of formulation performance, independent of delivery platform or device. The proprietary UMAX technology delivers unique, crystalline, excipient free, highly performing, stable drug particles that offer significant and distinct and quantifiable advantages over current industry practice, and now enables the development and optimization of a wide range of mono and combination inhalation therapies.
Successfully demonstrated on over 30 generic and novel drug molecules and combinations, customer demand is driving the rapid commercialization program. Critically the new UMAX approach does not utilize destructive high energy milling classically used in the preparation of inhalation medicines. This historic methodology introduces significant variability into drug product and formulation performance with respect to delivered dose, dose content uniformity, dose-to-dose variation, and restricts product shelf life. In addition UMAX does not require the use of any force control agents or exotic excipients in the formation of its unique crystalline constructs, offering significant benefits in ease of formulation and device reliability, and removing potential safety concerns over long term exposure to chemical additives.
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Keywords : API GMP particle engineering Prosonix Umax
Prosonix Ltd.
Robert Robinson Avenue 1
OX4 4GA Oxford
UK
Tel: +44 1865 784250
Fax: +44 1865 784251
Web: www.prosonix.co.uk
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