Resveratrol (3,5,4′-trihydroxy-trans-stilbene) is a phytoalexin currently only available as an oral dietary supplement but Jupiter is investigating a novel formulation of the plant extract to treat a number of rare diseases linked to gene deficiencies.
Before making doses for human PK studies and Phase II clinical studies, the Delaware-based pharma firm has selected contract development and manufacturing organisation (CDMO) Catalent Pharma Solutions to assess the candidate – known as JOTROL – across different softgel technology platforms to determine the optimum oral dosage form.
“Resveratrol has poor aqueous solubility and so poor bioavailability in humans [and] a novel formulation with the optimal delivery technology may improve the bioavailability of a pharmaceutical grade dose by modifying the release profile to tolerable levels, alleviating side effects, and unlocking more of its clinical potential,” a Catalent spokesperson told in-Pharmatechnologist.com.
“Catalent RP Scherer softgel technologies offer a broad range of options for the optimal delivery of this novel formulation. Catalent will assess different softgel technologies with a wide range of excipients to optimise JOTROL’s bioavailability and clinical performance.”
The work will be done at Catalent’s softgel development and manufacturing site in St. Petersburg, Florida, which offers technologies including the CDMO’s gelatin-free modified-release OptiShell platform.
Financial details of the contract have not been revealed.
There have been a number of investments and acquisitions in the softgel sector over the past few years, and Catalent itself has been one of the more active players.
“The utility of the softgel technology remains highly relevant across prescription, over-the-counter, dietary supplement, and cosmetics market segments worldwide,” the spokesperson told us.
“Catalent is committed to the softgel technology and its potential for effectively delivering medications and consumer health products. We will continue to offer integrated softgel services through a broad portfolio of formulation and capsule technologies coupled with a large, unmatched in the industry, global network of softgels facilities.”