Catalent's OptiShell Technology is Delivery Platform for OPKO Health's New Chronic Kidney Disease Treatment

Catalent Pharma Solutions welcomed the announcement by OPKO Health that FDA has accepted for review OPKO’s New Drug Application for a new treatment for chronic kidney disease (CKD) and vitamin D insufficiency, which uses Catalent’s proprietary OptiShell softgel technology as its delivery platform.

OPKO Health's product, calcifediol modified-release capsules with the proposed trade name Rayaldee, has been developed for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 CKD and vitamin D insufficiency.

Catalent’s OptiShell platform allows for high-temperature encapsulation of semi-solid fill material within a non-gelatin, plant-based shell. OptiShell was selected as the optimum delivery method for OPKO’s Rayaldee.

Rayaldee will be manufactured at Catalent’s North American Softgel Center of Excellence in St Petersburg, FL. Catalent is currently developing multiple OptiShell programs, providing optimal solutions for challenging drug compounds contained within complex fill formulations.

OptiShell capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. As a result, soft capsules containing semi-solid matrices for modified-release of poorly soluble and/or poorly permeable drug compounds are now an option for drug developers. For immediate-release applications, OptiShell technology expands the range of compatible excipients available for developing lipid-based capsule formulations, providing more solutions for unique drug delivery challenges.

“Rayaldee represents the first time that a semi-solid fill drug product has been delivered in a softgel,” commented Dr Aris Gennadios, Catalent’s President, Softgel Technologies. “We have worked closely on the development of Rayaldee with OPKO to bring this important new therapy to market in the most effective manner, in the shortest possible timeframe.”

”FDA acceptance of this NDA should be cheered by healthcare professionals who care for CKD patients,” commented Dr Kevin J. Martin, Director of Division of Nephrology at Saint Louis University School of Medicine. “If approved, Rayaldee will provide a new therapeutic option for controlling elevated parathyroid hormone levels in this large and undertreated patient population.”