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news.Ashland Specialty Ingredients, a commercial unit of Ashland, will add a Good Manufacturing Process (GMP) hot-melt extruder to its R&D center at Columbia, US, to better poorly soluble drug compounds.
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The 18mm Leistritz extruder helps make the drugs more soluble with dispersions from Ashland, thereby scaling up to GMP clinical and commercial quantities produced by hot-melt extrusion.
Ashland has developed multiple solid dispersions formulations with pharmaceutically acceptable polymers including Plasdone S-630 copovidone and Klucel hydroxypropyl cellulose (HPC).
The company said it can now leverage its experience in hot-melt extrusion processes at a GMP level.
At present, Ashland offers formulation development and GMP manufacturing of spray-dried dispersions ranging from proof-of-concept to clinical- and commercial-scale manufacturing.
The company will complete installing and testing of the equipment in the fourth quarter of this year and operation is likely to begin in early 2012.