Aptuit is manufacturing Phase III materials for Iroko using a nanoformulation technology that produces fast-dissolving particles.
Iroko Pharmaceuticals acquired the technology, called SoluMatrix, last month when it bought iCeutica. Nanoparticles produced by the technology can be used to create the low dose, short duration formulations the US Food and Drug Administration (FDA) wants for certain products.
“Our strategic focus responds to the directive of the FDA that NSAIDs (nonsteroidal anti-inflammatory drugs) should be used at the lowest effective dose for the shortest possible duration”, said John Vavricka, CEO of Iroko.
The FDA made comments about the dose and duration of NSAIDs when it asked Pfizer to voluntarily withdraw Bextra (valdecoxib) from the market in 2005. Iroko believes SoluMatrix can help produce NSAIDs with the low doses desired by the FDA without compromising efficacy.
Phase II trials of three NSAIDs developed using SoluMatrix have been completed and Iroko is now advancing the candidates to the next stage. Aptuit will support this process by manufacturing supplies for Phase III trials and batch materials to satisfy requirements for product registrations.
SoluMatrix consists of GRAS (generally recognised as safe) materials that are added to the mill with dry active drug. Dry milling these materials according to defined process parameters produces a superfine powder that is stopped from clumping together into big particles.
The resulting powder can be formulated into oral, inhalable, injectable and intranasal delivery doses. Claimed benefits include: lower dose needed to achieve a therapeutic effect; faster onset of action; and improved compliance by eliminating the need to take with or without food.
Aptuit was unable to provide in-PharmaTechnologist with additional information in time for publication.