CyDex Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued a patent to CyDex entitled “Sulfoalkyl Ether Cyclodextrin Compositions.” This patent, along with other previously issued technology patents, will provide broad protection for CyDex’s Captisol technology until 2029. The most recent of these previously issued patents – for a new Captisol that flows better, dissolves faster, and packs more densely than previous morphologies – was announced on December 9, 2009.
The patent announced (US Patent No. 7,635,773) covers a manufacturing process for producing ultra high-purity modified cyclodextrins, and specifically the beta cyclodextrin sulfobutyl ether sodium salt product known as Captisol. Captisol is CyDex’s proven enabling drug delivery technology that aids in the solubilization, stabilization and taste masking of active pharmaceutical ingredients.
“Receiving this new patent is an important achievement as we continue to license Captisol technology and develop our own products that target unmet needs in hospital intravenous therapy,” said Dr. Theron Odlaug, President and Chief Executive Officer of CyDex Pharmaceuticals. “High-purity Captisol removes many impurities and degradants so that the composition can be used to increase the stability of highly sensitive active pharmaceutical ingredients. Together with the morphology patent we received earlier this month, this patent ultimately provides broader protection for our clients using Captisol and provides them with critical life-cycle management for their products.”
Captisol is manufactured using a validated, patent-protected process and conforms to USP <1078> on Good Manufacturing Practices for Bulk Pharmaceutical Excipients.
CyDex Pharmaceuticals, Inc. is a specialty pharmaceutical company developing products and licensing its Captisol technology. Captisol is currently incorporated in five FDA approved medications and marketed by three of the company’s licensees: Pfizer, Bristol-Myers Squibb and Prism Pharmaceuticals.