Catalent Pharma Solutions will evaluate Jupiter Orphan Therapeutics’ (JOT) novel formulation of resveratrol, JOTROL, for delivery using its R.P. Scherer softgel technology. Catalent will assess different softgel delivery technologies for JOTROL to determine the optimum oral dosage form, prior to manufacture of doses for human PK studies and Phase II studies.
 
JOTROL, which is being developed to resolve resveratrol’s poor bioavailability and dose limiting gastrointestinal side effects, is being studied in multiple preclinical and clinical trials 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.
 
From its 453,000-sq.-ft., softgel development and manufacturing center in St. Petersburg, FL, Catalent will assess both conventional softgel and its OptiShell gelatin-free technology, which allows for higher fill temperatures and pH, which 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,” said 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, chief executive officer 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.”