CyDex has won the first regulatory approval in Japan for a pharmaceutical product using its Captisol drug delivery technology designed to improve the delivery of insoluble and unstable active pharmaceutical ingredients.
Pfizer Japan yesterday confirmed that Japan's Ministry of Health, Labor and Welfare approved manufacturing of Vfend (voriconazole), an antifungal product that Pfizer has marketed in the US and Europe since 2002. Pfizer introduced Vfend intravenous and oral forms last month in Japan. The iv formulation combines the active ingredient voriconazole with Captisol, a polyanionic beta-cyclodextrin excipient.
With the Japanese approval, Captisol has now been cleared for marketing as part of Vfend in the top three pharmaceutical markets in the world - the US, Japan and Europe.
Pfizer licensed Captisol from CyDex in 1993 for use in formulations of antifungals and other Pfizer-owned new drugs. In addition to Vfend, Pfizer markets a second Captisol-based drug, an injectable formulation of schizophrenia drug Zeldox/Geodon (ziprasidone mesylate), in the US and Europe.
Captisol is designed to enable the safe, effective delivery of medications by improving the solubility, stability and bioavailability of drug compounds. The technology works by forming complexes with water-insoluble drugs, making them water-soluble.
When given by injection, a Captisol formulation helps carry a drug into the patient's bloodstream, whereupon the excipient and the drug dissociate, allowing the active ingredient to exert its desired pharmacological effect.
Meanwhile, in oral and inhaled formulations, Captisol can improve bioavailability by improving dissolution and solubility of drug compounds. Last year CyDex reported the results of a study showing that a Captisol formulation of the asthma drug budesonide outperformed delivered via a nebulisers.