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.
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.