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news.Iroko Pharmaceuticals and Aptuit have entered into a services agreement, under which Aptuit has agreed to produce for Iroko Phase III supplies of lower dose, nanotechnology formulations for multiple nonsteroidal anti-inflammatory drugs (NSAIDs).
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Iroko has already completed Phase II studies for all of these products.
Aptuit will also make batch material to satisfy requirements for product registrations.
While serving as a contract manufacturer, Aptuit will make use of the proprietary SoluMatrix technology of Iroko partner iCeutica.
This nanoformulation technology makes possible the production of medications consisting of sub-micron, fast-dissolving drug particles.
Iroko CEO John Vavricka said their strategic focus responds to the directive of the US Food and Drug Administration that NSAIDs should be used at the lowest effective dose for the shortest possible duration.
"We believe our patented nanoformulations will enable the development of NSAIDs at significantly lower doses without compromising onset of action or effectiveness. The consistent quality and attention to detail which Aptuit brings to its work will be an important resource as we advance these products toward the market," Vavricka said.