Catalent Pharma Solutions reports that the US Food and Drug Administration has accepted for review OPKO Health’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 delivery method for OPKO's Rayaldee. Rayaldee will be manufactured at Catalent's North American Softgel Center of Excellence in St. Petersburg, Florida.

Catalent is currently developing multiple OptiShell programs. OptiShell capsules use a patented shell derived from plant-based polysaccharides that are used for the encapsulation of higher melting-point fill formulations. 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, according to Catalent.

Source: Catalent