Catalent, JOS Pharmaceuticals Enter Zydis Formulation Agreement

Catalent has signed an agreement with JOS Pharmaceuticals, a clinical stage biopharma company focused on anesthesiology, to undertake a feasibility study for the potential development of a licensed cannabidiol (CBD) product for use as an anesthetic premedication using Catalent’s Zydis orally disintegrating tablet (ODT) technology.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water. The feasibility study will be conducted at Catalent’s facility in Swindon, U.K., and will focus on establishing proof of concept and prototype development of a Zydis formulation of a highly purified, naturally derived CBD. JOS Pharmaceuticals extracts CBD from certified hemp and is developing its se•d8 prescription CBD wafer for awake sedation anesthesia administered for cataract surgery, as well as anxiolysis during magnetic resonance imaging (MRI) procedures.

“Our clinical trial product is specifically designed to provide rapid and reliable relaxation for the patient, while still allowing for awake cooperation during the procedure. It would be paradigm changing to replace the DEA controlled drugs used currently as premedication with a safe and effective botanical,” said Stephen D. Ochs, M.D., Chief Executive Officer of JOS Pharmaceuticals.

“Zydis is an ideal dose form for the delivery of drugs, as it offers an easy and convenient route of administration for patients that can also assist in the rapid onset of effects,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “CBD derived from hemp is a rapidly evolving market, and our team in Swindon is looking forward to applying its experience and expertise in product development to this licensed program.”

Catalent’s 250,000-sq.-ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces more than one billion ODTs annually.