Ashland Inc. adds clinical-scale, hot-melt extrusion technology for poorly soluble compounds

FRANKFURT, Germany - Ashland Specialty Ingredients, a commercial unit of Ashland Inc. (NYSE: ASH), today announced it will add a Good Manufacturing Process (GMP) hot-melt extruder in its Columbia, Md., USA, R&D center to better serve pharmaceutical companies working with poorly soluble drug compounds. The 18mm Leistritz* extruder allows companies that seek to commercialize drugs, which are made more soluble with dispersions from Ashland, to scale up to GMP clinical and commercial quantities produced by hot-melt extrusion. Ashland will finish installing and testing the equipment in the fourth quarter of this year and begin a full-service offering early in 2012.

According to Randy Bull, Ph.D. of Ashland Specialty Ingredients, the addition completes Ashland’s goal to provide the most comprehensive solubility solution for active ingredients developed using solid-dispersion technology, which is produced by either hot-melt extrusion or spray drying. “Adding a GMP hot-melt extruder to complement our existing extruder in our Wilmington, Del. Research Center  takes us beyond pilot-scale capacity to clinical scale, making Ashland the only excipient supplier in the world capable of fully supporting the two techniques used in the preparation of solid dispersions,” said Bull. “By early next year, Ashland will have the broadest capabilities among excipient suppliers to enhance the solubility of poorly soluble actives prepared with solid dispersion technology. The distinction is significant in that Ashland will be able to conduct kinetic-solubility and polymer-screening tests using both spray drying and hot-melt extrusion techniques to determine the best solubility solution in clinical trials.”

Bull went on to say that every drug active will have its own requirement and each project will have physical parameters that limit the techniques available to enhance solubility. “Providing solubility services for both spray drying and hot-melt extrusion allows us to examine these techniques side by side utilizing all polymer chemistries accepted in solid-dispersion applications.”

Pharmaceutical scientists and engineers at Ashland have developed multiple solid dispersions formulations with pharmaceutically acceptable polymers including  Plasdone™ S-630 copovidone  and Klucel™ hydroxypropyl cellulose (HPC). The company’s scientists draw on in-house expertise in material and polymer science, as well as experience with pharmaceutical formulations, to enable the commercial development of poorly soluble drugs. Ashland can now leverage its experience in hot-melt extrusion processes at a GMP level.

Ashland currently offers formulation development and GMP manufacturing of spray-dried dispersions ranging from proof-of-concept to clinical- and commercial-scale manufacturing.

Delivering pharmaceutical and nutraceutical performance since the 1950s, Ashland creates value for its customers through applications knowledge, regulatory support and a powerful excipient portfolio: 

• • Advantia™ and Aquarius™ coating systems



• • Aqualon™ ethylcellulose



• • Aqualon™ and Blanose™ sodium carboxymethylcellulose



• • Benecel™ methylcellulose and hypromellose



• • Klucel™ hydroxypropylcellulose



• • Natrosol™ hydroxyethylcellulose



• • Plasdone™ copovidone



• • Plasdone™ povidone



• • Polyplasdone™ crospovidone

Ashland Specialty Ingredients offers industry-leading products, technologies and resources for solving formulation and product performance challenges in key markets including personal care, pharmaceutical, food and beverage, coatings and energy. Using natural, synthetic and semi-synthetic polymers derived from plant and seed extract, cellulose ethers and vinyl pyrrolidones, Ashland Specialty Ingredients offers comprehensive and innovative solutions for today's demanding consumer and industrial applications.

In more than 100 countries, the people of Ashland Inc. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, food and beverage, personal care, pharmaceutical, tissue and towel, and water treatment. Visit www.ashland.com to see the innovations we offer through our four commercial units – Ashland Specialty Ingredients, Ashland Water Technologies, Ashland Performance Materials and Ashland Consumer Markets (Valvoline).

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™Trademark of Ashland or its subsidiaries, registered in various countries