Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that it has signed a commercial supply agreement with Edenbridge Pharmaceuticals, LLC, for a novel formulation of glycopyrrolate using Catalent’s proprietary 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 awaiting 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.
“We are very excited to work with a world-class partner like Catalent to bring this product to patients across the United States,” commented Ryan Collins, CEO at Edenbridge. “This product will satisfy a clear unmet need in the market.”
“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.
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