The formulation is intended for use as adjunctive therapy in the treatment of patients with peptic ulcer
Catalent, a global provider of advanced delivery technologies, development, and manufacturing solutions for the pharmaceutical industry, has signed a commercial supply agreement with Edenbridge Pharmaceutical for a novel formulation of glycopyrrolate using Catalent’s proprietary Zydis orally disintegrating tablet (ODT) delivery technology.
The formulation is intended for use as adjunctive therapy in the treatment of patients with peptic ulcer. The Zydis formulation of glycopyrrolate is yet to receive FDA approval, however the companies expect it in December 2021.
Zydis technology creates a freeze-dried tablet that disperses quickly in the mouth without water, Catalent says. Catalent will manufacture the drug at its facility in Swindon, UK, and has worked on the program since 2017, assisting 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.”