OPKO’S Rayaldee product receives FDA approval

First drug to use Catalent’s proprietary OptiShell capsule technology to achieve extended release profile.

“We are pleased that OptiShell was selected as the optimum delivery method for OPKO’s Rayaldee and that through our close collaboration we have helped OPKO to bring the NDA for this important drug to approval on schedule,” commented Dr Aris Gennadios, Catalent’s President, Softgel Technologies. “Catalent is pleased that Rayaldee is the first treatment to use our OptiShell technology to deliver a semi-solid fill, extended release drug.”

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

OptiShell capsules utilize a patented shell derived from plant polysaccharides and are ideally suited for the encapsulation of higher melting-point fill formulations, such as 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.