Hovione and PSI team on poorly soluble APIs
The collaboration will see PSI developing the solubilization process and resulting drug product with Hovione managing the scale-up and industrialization of the spray drying process.
The primary focus of the partnership will be on BCS Class II active pharmaceutical ingredients (API), which are those that exhibit low solubility and high permeability.
Dave Hoffman, President, Hovione US Operations, said "Teaming up with PSI will give their customers an integrated solution which will allow us to go from drug product and process design to feasibility and development to industrial application in record time."
Particle Sciences' CEO, Mark Mitchnick, agreed, explaining that : "Our unique contribution is to develop products that maximize clinical effect, and after that Hovione takes over with their technological and industrial expertise and regulatory compliance.”
Mitchnick went on to say that: “We will really be able to save our clients quite a lot of time."
The accord marks the latest stage in Hovione’s efforts to build its capabilities in spray-drying, which began with the acquisition of an aseptic spray-drying line from US firm Acusphere in 2009.
PSI has been growing its solubilisation technology business since it partnered with Microfluidics in 2009 in an agreement focused on expanding its contract processing services offering.
At the time Robert Lee, vice president of pharmaceutical development at Particle Sciences, said “One area of interest to PSI is adding the Microfluidizer processor to its existing approaches for particle size reduction of poorly water-soluble APIs to the submicron range, which is an increasingly important formulation approach for pharmaceutical API development."
More recently the US firm entered into an exclusive agreement with Israeli developer SoluBest last year.
Under the deal PSI become the only contract research organisation (CRO) to offer the solubility enhancing drug/polymer platform to pharmaceutical industry clients.