Catalent to Develop Softgels for Orphan Drug Candidate

Catalent Pharma Solutions has announced that the company will evaluate Jupiter Orphan Therapeutics, Inc.’s novel formulation of resveratrol, JOTROL, for delivery using Catalent’s R.P. Scherer softgel technology. Under the agreement announced Jan. 9, 2017, Catalent will assess different softgel delivery technologies for JOTROL to determine the optimum oral dosage form, before manufacturing doses for human pharmacokinetics 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 pre-clinical and clinical trial programs for the treatment of rare diseases linked to single gene deficiencies, as reported in a press statement.

Catalent will assess both conventional softgel and Catalent’s proprietary OptiShell gelatin-free technology. Catalent reports that OptiShell allows for higher fill temperatures and pH, and can accommodate semi-solid and highly viscous formulations and a wider range of excipients designed to improve bioavailability and stability.

Catalent will conduct its work on JOTROL from its St. Petersburg, FL facility, which 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