Expanding Excipient Portfolios

Excipient manufacturers expand production capacity and partner to broaden their offerings.
Apr 02, 2012
Volume 36, Issue 4

Excipients play an important role in pharmaceutical formulations by adding functionality or facilitating the processing of a drug product. Several excipient manufacturers are planning or recently expanded production capacity, have made acquisitions, or have partnered to broaden their product portfolios and related service offerings.

Company activity

Patricia Van Arnum
Ashland Specialty Ingredients recently added low-viscosity, pharmaceutical-grade polyvinyl pyrrolidone (PVP) capacity for its Plasdone excipients at its manufacturing facility in Calvert City, Kentucky. PVP is a synthetic polymer used as a tablet binder. Ashland currently produces PVP at its manufacturing facilities in Calvert City, Kentucky, and Texas City, Texas.

In January 2012, Ashland also announced that it planned to expand production of Polyplasdone crosslinked polyvinylpyrrolidone (PVPP) at its manufacturing facility in Texas City. The company plans to complete the addition of a new PVPP production unit at the site by late 2013. Polyplasdone PVPP is a synthetic polymer used as a tablet disintegrant and drug-dissolution aid. The company says it expects steady growth in PVPP driven by an industry need for formulation ingredients that improve the dissolution of poorly soluble drugs and growth in emerging markets generated by increased demand for generic-drug products and consumer demographics. In August 2011, Ashland acquired International Specialty Products, an excipient producer and manufacturer of the Plasdone and Polyplasone products.

In October 2011, Ashland Specialty Ingredients launched three new commercial grades of Benecel hypromellose (HPMC) excipients for the formulation of matrix tablets. These commercial grades (HPMC K250 PH PRM, HPMC K750 PH PRM, and HPMC K1500 PH PRM) of intermediate-molecular-weight polymers are designed to provide more predictable controlled-release profiles compared with blending legacy grades of HPMC. HPMC is used in hydrophilic matrix systems. Molecular weight plays a key role in dictating drug release, so formulators select specific molecular weight grades based on drug solubility and desired release profile, which often required blending different grades of HPMC. The new grades eliminate the need for such blending.

Meanwhile, Univar formed an agreement with Dow Corning in March 2012 for the US distribution of its silicone-based products, including pharmaceutical excipients, process aids, and fluids for siliconization. The agreement includes the United States and Puerto Rico and is an extension of the companies' existing partnership in Canada. Univar will sell a range of Dow Corning branded products, including simethicones, dimethicones, medical antifoams, and specialty fluids. The products are used in a variety of end-use applications, formulations, and manufacturing processes.

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BASF launched a new packaging system, PeroXeal, last October, to protect its pharmaceutical excipient, Kollidon, which is based on polyvinylpyrrolidine, against contact with oxygen and subsequent oxidation. The system makes it possible to reduce the level of peroxide of Kollidon, thereby making the excipient suitable for use in oxygen-sensitive formulations. The PeroXeal packaging system consists of a multilayered and heat-sealed plastic film used as inner packaging material. The new packaging has been introduced for most Kollidon products at the company's Ludwigshafen and Minden, Germany, sites. BASF will offer all grades of the Kollidon line with the new technology starting by the end of 2013.

Also in October, BASF and Colorcon formed a collaboration for the development of future film-coating systems using BASF's Kollicoat SmartSeal 30D and new Colorcon preformulated additives. Colorcon developed a preformulated additive system for use with Kollicoat SmartSeal 30D to enable efficient preparation and application of this polymer in taste-masking applications. The preformulated additive lowers the number of materials to be dispensed by 50% and reduces the preparation time by almost 40%, according to the companies.

BASF launched Kollicoat Smartseal 30 D, an aqueous dispersion of a film-forming polymer with taste-masking and moisture-barrier applications in 2011. The excipient is highly impermeable to water vapor, which helps preserve the potency of sensitive active ingredients, according to the company. The polymer is stable in saliva and specifically soluble in gastric juice. These properties allow for effective protection from unpleasant taste in the patient's mouth and rapid release and onset of active ingredient action in the stomach.

Also in 2011, Dow Polyglycols, Surfactants & Fluids, a business unit of Dow Chemical, announced it is expanding capacity for Carbowax Sentry solid-grade polyethylene glycols, which are used as pharmaceutical excipients, APIs (i.e., laxatives) and in personal-care products. The company announced the expansion last October with the expansion slated to begin in 2012 to support global supply.

In late 2010, the chemical company Celanese launched VitalDose, an ethylene vinyl acetate (EVA) polymer-based excipient for controlled-release pharmaceutical applications. The EVA-based excipients can be used in the design of transdermal, subcutaneous implant, and mucosal insert dosage forms.

On the acquisition front, DMV–Fonterra Excipients GmbH & Co. KG, the 50–50 joint venture for pharmaceutical excipients between the Dutch dairy company Royal Friesland Campina and the New Zealand dairy company Fonterra, acquired the business and assets of Brahmar Cellulose Private Limited (BCPL) in 20011. The move positions the company in pharmaceutical microcrystalline cellulose and sodium carboxyl methylcellulose.

Evonik completed the acquisition of SurModics Pharmaceuticals, a subsidiary of SurModics, in late 2011. The acquisition gives Evonik ownership of SurModics' parenteral dosage forms services and bioresorbable polymers business. The new business includes two facilities for the development and manufacturing of polymers and drug-delivery systems in Birmingham, Alabama. Formulation approaches used with the bioresorbable polymers include bioresorbable microparticles, nanoparticles, liposomes, implants, and other polymer-based configurations. Evonik is a producer of functional pharmaceutical excipients, which includes coatings and matrix systems for controlled release of APIs in tablets and other oral dosage forms through its Eudragit product line. In 2011, Evonik acquired the Resomer polymer business from Boehringer Ingelheim. These polymers are used for controlled release injectables, bioresorbable implants and medical devices.

In May 2011, Avantor Performance Chemicals opened a new pharmaceutical formulation application laboratory in Sinnar Nashik, Maharashtra, India, with its partner RanQ Remedies. The new laboratory is used to characterize excipients, perform functional testing, develop and characterize drug formulations, and support customer applications and product implementation. In terms of excipients, RanQ has a position in microcrystalline cellulose and sodium starch glycolate and also has expertise in developing premixed and other application-focused pharmaceutical excipients that result in a homogenous mix and coprocessed excipients.

In Ireland, FMC completed an expansion of its microcrystalline cellulose plant in Cork. Production from the final phase of the expansion began in March 2011 and increased FMC's global capacity by 25% for pharmaceutical- and food-grade microcrystalline cellulose. FMC operates another microcrystalline cellulose plant in Newark, Delaware. In March 2011, Grace Davison Discovery Sciences, part of W.R. Grace & Co., opened a new technical service knowledge center in Southern India for customers in the pharmaceutical and biotechnology industries.

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