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