Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced that it is to evaluate Jupiter Orphan Therapeutics, Inc.’s (JOT) novel formulation of resveratrol, JOTROL, for delivery using Catalent’s R.P. Scherer softgel technology.
Under the agreement, Catalent will assess different softgel delivery technologies for JOTROL to determine the optimum oral dosage form, before going on to manufacture doses for human PK studies and Phase II clinical studies.
JOTROL, which is being developed to remedy resveratrol’s poor bioavailability and dose limiting gastrointestinal side-effects, is being studied in multiple preclinical and clinical trial programmes in progress for the treatment of rare diseases linked to single gene deficiencies. These include Friedreich’s Ataxia and Mucopolysaccharide (MPS) diseases, as well as partner programs for treatments in pancreatic cancer, Machado-Joseph and Alzheimer’s disease.
Under the arrangement, Catalent will assess both conventional softgel and Catalent’s proprietary OptiShell gelatin-free technology, which allows for higher fill temperatures and pH, and therefore can accommodate semi-solid and highly viscous formulations, and a wider range of excipients designed to improve bioavailability and stability.
“Developing better treatments that improve patient experience and lead to better real world outcomes is vital for drug innovators’ success,” commented Dr Aris Gennadios, Catalent’s President of Softgel Technologies. “Catalent is dedicated to using our breadth of formulation technology expertise and experience across thousands of innovative molecules to improve patient acceptance and adherence.”
Christer Rosén, Chairman, CEO and Founder of JOT, added: “We selected Catalent as our development partner for our JOTROL therapies because of their breadth of experience in formulation and softgel technology, coupled with their wide range of complementary capabilities.”
Catalent will conduct its work on JOTROL from its primary, 453,000 square feet, North American softgel development and manufacturing centre-of-excellence in St Petersburg, Florida, where the company offers formulation development and manufacturing of prescription and over-the-counter softgels, and has an annual capacity of more than 18 billion capsules a year.