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US FDA to review new drug application using Catalent softgel drug delivery tech

By Zachary Brennan+


US FDA to review new drug application using Catalent softgel drug delivery tech

The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.

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, which has been developed for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 CKD and vitamin D insufficiency.

Rayaldee will be manufactured at Catalent’s North American facility in St. Petersburg, Florida. Catalent is currently developing multiple other OptiShell programs.

The capsules utilize a patented shell derived from plant polysaccharides that are ideally suited for the encapsulation of higher melting-point fill formulations, like Rayaldee. For immediate-release applications, OptiShell technology expands the range of compatible excipients available for developing lipid-based capsule formulations.

“Rayaldee represents the first time that a semi-solid fill drug product has been delivered in a softgel,” said Aris Gennadios, Catalent’s President, Softgel Technologies. 

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