Catalent, Edenbridge Pharma Enter Zydis Formulation Supply Agreement

Catalent, a global provider of delivery technologies, development, and manufacturing services for drugs, biologics, cell and gene therapies, and consumer health products, has signed a commercial supply agreement with Edenbridge Pharmaceuticals, LLC, for a novel formulation of glycopyrrolate using Catalent’s Zydis orally disintegrating tablet (ODT) delivery technology intended for use as adjunctive therapy in the treatment of patients with peptic ulcer. The Zydis formulation of glycopyrrolate is pending U.S. FDA approval, which is expected in December 2021.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water and is recognized as one of the world’s best-performing ODTs. Its ability to deliver the tablet without water may provide additional benefit to patient populations where fluid intake is to be limited. Catalent will manufacture the drug at its facility in Swindon, U.K. and has worked on the program since 2017 and assisted in its regulatory submission.

“The Zydis technology offers many advantages in formulation design and is ideal for patients who suffer from conditions that make swallowing a conventional dosage form challenging,” said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. “This program with Edenbridge clearly demonstrates how a proven drug can be reformulated into a novel drug platform to address challenges in administration, including dysphagia and water-avoidance, and can help improve compliance in some patient groups.”

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