CPhI NEWS: Ashland unveils comprehensive excipients business

Following the recent acquisition of International Specialty Products (ISP), Ashland Specialty Ingredients, a commercial unit of Ashland Inc showcased its expanded excipient portfolio and global r&d capabilities and outlined its plans to support formulators of pharmaceuticals with expertise in a larger range of formulation approaches and manufacturing techniques, as well as with a larger portfolio of proven excipients.

‘The former ISP and Ashland Aqualon Functional Ingredients businesses are now combined as one business – Ashland Specialty Ingredients – to provide the most comprehensive resources available from one excipient supplier,’ said Jeffrey Wolff, group vice president, Pharmaceutical & Nutrition Specialties, Ashland Specialty Ingredients. ‘With one of the world’s most diversified portfolios of pharmaceutically acceptable excipients, and an R&D team focused on all of the major formulation trends, we can help drug makers increase their success on formulation projects.’

He said the combination of Ashland and ISP has positioned the company to better help pharmaceutical formulators address the major challenges facing them today, including improving the efficacy of poorly soluble drugs; increasing use of controlled-release technology; orally disintegrating tablet forms for improved patient compliance; and continuous manufacturing of oral dosage forms.

A great deal of research taking place at Ashland today will form the basis of technical solutions that address these formulation and manufacturing trends. ‘With all of these formulation trends taking place simultaneously, a need exists for a company such as Ashland to provide a range of excipient solutions,’ said Wolff. ‘We believe formulators now have a comprehensive source for help in achieving better outcomes, whatever the formulation challenge.’

Three of the company’s Benecel hypromellose (HPMC) excipients are now available for the formulation of matrix tablets. These commercial grades of intermediate-molecular-weight polymers deliver more predictable controlled-release profiles than may be possible with blending legacy grades of hypromellose. Benecel HPMC K250 PH PRM, HPMC K750 PH PRM and HPMC K1500 PH PRM were developed to address predictability and consistency issues stemming from blending practices and to provide formulators additional choices to more easily achieve their desired release profile.

‘Molecular weight plays a key role in dictating drug release, so formulators choose specific molecular weight grades based on drug solubility and desired release profile,’ explained Divya Tewari, group leader, Pharmaceutical R&D, Ashland Specialty Ingredients. ‘Our customers previously often needed to blend two or more molecular weight grades to achieve the desired target release profile for controlled-release tablets as actives and drugs have become more complex.’

Ashland Specialty Ingredients is also to add a GMP hot-melt extruder at its r&d centre in Columbia, Maryland, to serve pharmaceutical companies working with poorly soluble drug compounds. The 18mm Leistritz extruder allows companies that seek to commercialise 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.

‘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,’ said Dr Randy Bull, of Ashland Specialty Ingredients. ‘Adding a GMP hot-melt extruder 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.

‘Providing solubility services for both spray drying and hot-melt extrusion allows us to examine these techniques side by side utilising all polymer chemistries accepted in solid-dispersion applications.’

Ashland has also launched a range of natural colours for use in oral dosage forms. Derived from vegetable, animal and mineral sources, the compounds that make up the Aquarius coating systems natural colours palette are stable, label friendly, easy to use and can be combined with Ashland’s Aquarius MG coating systems' moisture-guard line.

‘Nutraceuticals are subject to food regulations, which are more restrictive than their pharmaceutical counterparts with regard to the permitted colorants used in tablet coating systems,’ said Laurie Kronenberg, new product leader, Pharmaceutical and Nutrition Specialties.

Furthermore, because major markets have differing compliance requirements – for instance, iron oxides are allowed in pharmaceutical and food applications in the EU, but are only for pharmaceutical use in the US – Ashland saw a need for a broader colour palette for its tablet coating systems that addresses regional regulatory requirements.