Tracking Excipients - Pharmaceutical Technology

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Tracking Excipients
A review of recent product innovations, policy developments, and growth prospects in the excipients market.


Pharmaceutical Technology
Volume 33, Issue 4, pp. 44-51


(IMAGE: EMANUELE TARONI/GETTY IMAGES)
Although constituting a relatively small value of the cost of manufacturing a drug, excipients play a vital role in the formulation of pharmaceutical products. Recent product innovations include applications in orally disintegrating tablets and controlled-release formulations. Broader issues affecting the excipient market include supply-chain integrity, quality by design (QbD), and longer term, the application of nanotechnology in formulations. As these issues unfold, moderate growth is expected for the global excipients market.

Innovation in excipients

Although introducing new excipients may be a slow and costly process, the excipient market is not without innovation. Excipient makers use a strategy of developing excipient blends to achieve multifunctionality and introduce new grades of existing excipients to enhance performance for specified applications. Excipients for orally disintegrating tablets, controlled-release formulations, immediate-release applications, and topical formulations are recent examples.


Patricia Van Arnum
Mallinckrodt Baker (Phillipsburg, NJ), a business unit of Covidien (St. Louis, MO) launched PanExcea MC200 for oral disintegrating tablet applications in November 2008. The excipient combines two ingredients that interact at a subparticle level to facilitate rapid disintegration and dispersion of a tablet in the oral cavity, increase active pharmaceutical ingredient (API) loading capacity, and enhance taste-masking. The excipient may be used with standard manufacturing and packaging equipment, which the company says can potentially eliminate licensing orally disintegrating technology and new equipment investment. Mallinckrodt also launched a performance excipient for immediate release-applications in 2008. It is based on microcrystalline cellulose, hydroxypropyl methylcellulose, and crospovidone, according to the release and company information.

In 2008, Mallinckrodt Baker teamed with the contract research organization Rubicon Research (Mumbai) in a licensing and commercialization agreement to expand its performance excipient platform. The two companies plan to develop and launch additional products under Mallinckrodt Baker's PanExcea line of performance excipients through 2009, according to an August 2008 joint press release. Under the agreement, Rubicon is providing technology development and formulation expertise.

Eastman Chemical (Kingsport, TN) added CA-3203 to its line of cellulose ester excipients in 2008. The product can be used in controlled-release applications involving membrane release or matrix release.

International Specialty Products (Wayne, NJ) expanded its Advantia line of coating systems with the addition of Advantia Preferred HS coatings in 2008. The new coatings are based on combinations of polymers and plasticizers for immediate-release film coating of oral solid dosage forms for pharmaceutical products and dietary supplements. The coating can be applied in up to 25% high-solid suspension, according to the company.

The product improves film adhesion and achieves good film strength and flexibility. The issue of film adhesion arises in tablet cores with ingredients that may make tablet surfaces either more hydrophobic or less porous, which in turn can comprise film adhesion. The company says that recent studies show that products do not slow tablet disintegration and dissolution, which are critical properties for film coatings applied to immediate-release dosage forms.

NuSil Technology (Carpinteria, CA) launched a new water-resistant dimethicone pharmaceutical excipient, MED-323, a trimethyl end-blocked polydimethylsiloxane, for pharmaceuticals and cosmetics in May 2008. The product offers water repellency and may be used as an excipient in topical pharmaceutical applications.


ExcipientFest Americas
NuSil Technology also launched a line of silicone materials and services for drug delivery and combination medical device products in January 2009. The company provides silicone fluids, elastomers, and gels for drug delivery and medical devices, including matrix and reservoir-type delivery devices for transdermal, transmucousal, and long- and short-term implanted medical devices.


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