Captisol Technology Used in New Nexterone Fomulation

Manufacturer-prepared, premixed ready-to-use products represent a preferred approach to advance initiatives and professional standards for improving intravenous drug safety. Organizations that promote, support, and monitor implementation of practices intended to assure quality services in the hospital environment include the Joint Commission, the United States Pharmacopeia, and the American Society of Health System Pharmacists.

The most recent implementation of this in an approved pharmaceutical product is Prism Pharmaceuticals Inc.’s use of the Captisol technology in Nexterone Premixed Injection. Nexterone Premixed Injection recently received supplemental new drug application approval from the U.S. Food and Drug Administration. The new product is a premixed intravenous bag formulation for the initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

“CyDex has provided Prism Pharmaceuticals with technical support since they first licensed the worldwide rights to a Captisol-enabled amiodarone HCL formulation from us in 2006,” says Theron E. Odlaug, president and CEO, CyDex. “Prism's success in advancing this new, premixed IV bag formulation of Nexterone demonstrates not only the role Captisol can play in the development of novel products for intravenous therapy in the hospital setting, but also the productivity of this longstanding licensing relationship. It also underscores the value of our recent patents in providing our licensing partners with broader intellectual property protection and enhanced product life-cycle management capabilities. At the same time, as the fifth product commercially marketed by a CyDex partner, Nexterone Premixed Injection has the potential to further expand our licensing royalty revenue base as we continue to expand our portfolio of innovative products for acute care hospital applications.”

CyDex's Captisol technology improves the water solubility and stability of active pharmaceutical ingredients. Using Captisol enabled Prism Pharmaceuticals Inc. to formulate Nexterone Premixed Injection without the cosolvents polysorbate 80 and benzyl alcohol used in the innovator product — the antiarrhythmic agent amiodarone IV originally marketed as Cordarone Intravenous. Cosolvent-free Nexterone Premixed Injection does not require admixture at the time of use, enabling the product to be premixed and remain stable in storage for as long as two years.

Nexterone Premixed Injection is approved in two ready-to-use dosage forms with strengths of 1.5 mg/mL (150 mg/100 mL) for rapid loading infusion and 1.8 mg/mL (360 mg/200 mL) for subsequent infusion.

Captisol is protected by two recently granted patents; one is a new Captisol morphology that flows better, dissolves faster and packs more densely than previous material. The second patent protects an innovative process for manufacturing high-purity Captisol that removes impurities resulting in a new composition of matter, which further increases the stability of sensitive active pharmaceutical ingredients.