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

By Zachary Brennan

- Last updated on GMT

Related tags New drug application

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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