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
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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.
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.
Patricia Van Arnum
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.
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