Catalent Pharma Solutions, a Somerset, New Jersey-based drug-delivery technology company, has entered into an agreement with Jupiter Orphan Therapeutics (JOT), a Jupiter, Florida-based clinical-stage specialty pharmaceutical company, to develop a softgel oral dosage form of Jotrol (resveratrol), a dietary polyphenol.

Under the agreement, Catalent will assess different softgel delivery technologies before manufacturing doses for human pharmokinetic 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 programs 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.

Catalent will conduct its work on Jotrol from its primary, 453,000-square feet, North American softgel development and manufacturing center-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.

Source: Catalent Pharma Solutions