An advanced drug and gene therapy delivery provider has signed an agreement with a clinical-stage biopharmaceutical company to develop a cannabidiol (CBD) based anesthesia premedication.
Catalent on Tuesday announced an agreement with JOS Pharmaceuticals to develop the CBD-based premedication using its proprietary Zydis orally disintegrating tablet (ODT) technology.
As part of the agreement, Catalent will conduct a feasibility study for the premedication’s potential development.
“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,” says Catalent President of Oral and Specialty Deliver. “CBD derived from hemp is a rapidly evolving market, and our team in Swindon is looking forard to applying its experience and expertise in product development to this licensed program.”
According to Catalent, freeze-dried tablets created using the Zydis technology disperse almost instantly in the mouth without water.
Catalent says Zydis tablets are one of the world’s best-performing ODTs.
During the feasibility study, scientists at Catalent’s 250,000 square foot facility in Swindon, U.K. will work to establish proof of concept and develop prototypes.
The facility, which is home to Catalent’s Zydis development and manufacturing operations, produces more than one billion ODTs annually.
Catalent says the Zydis formulation prototypes will contain highly purified, naturally derived CBD.
Using certified hemp-extracted CBD, JOS Pharmaceuticals will develop its proprietary se•d8 prescription wafer to be used as awake sedation anesthesia during cataract surgery and 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,” says JOS CEO Stephen Ochs, M.D. “It would be paradigm changing to replace the DEA controlled drugs used currently as premedication with a safe and effective botanical.”
