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Posted: June 19, 2008
iCeutica Completes GMP Scale-Up for Its Nano-Sized Products
(Nanowerk News) iCeutica, Inc. announces that the first GMP clinical supplies have been manufactured for its partner, Iroko Pharmaceuticals, utilizing iCeutica's proprietary nano-sizing technology. The completion of the manufacturing campaign represents an important technical and commercial validation of the iCeutica platform.
"We are very pleased to achieve this significant milestone for iCeutica. Our nano-sizing technology has progressed from pilot plant
scale to commercial operation inside a GMP facility and is producing the consistent, quality products that we projected," said iCeutica President and CEO, Matt Callahan.
Iroko and iCeutica are collaborating on the application of iCeutica's nano-sizing platform to reformulate certain proprietary Iroko products. Iroko is guiding the progression of these reformulated products through the regulatory process, clinical trials and ultimate commercial launch.
"The products Iroko is developing with iCeutica will have significant and relevant benefits for patients, with enhanced onset of action, reduction in food-fast effects and potentially reduced side effects," said Iroko President and CEO, John Vavricka.
"iCeutica's nano-sizing platform is broadly applicable to a wide range of poorly soluble drug compounds and provides a novel and exciting approach to formulation development and drug product manufacturing. We look forward to working with our partners and on our internal pipeline in maximizing the potential of this important new technology," said Mr. Callahan.
iCeutica commercializes products developed utilizing its proprietary nano-sizing platform. The technology is an enabling reformulation platform, which provides simple and scalable processes to reformulate development stage and marketed products with solubility, delivery or bioavailability challenges.
About Iroko Pharmaceuticals LLC
Iroko is a pharmaceutical company focused on specialty therapeutic areas. The company acquires, develops and maximizes the potential of currently marketed pharmaceutical products. Iroko increases the revenues of acquired products through focused selling and marketing efforts and product life cycle management activities including development of relevant formulations to improve patient treatment.