OptiShell Capsule Innovation

Gelatin-free Softgel Studies: Development of Novel Shell Compositions and Processes Suitable for the “Hot Filling” of High Viscosity and Semi-Solid Fill Materials

Authors:  Norman Stroud, Keith Tanner, Elizabeth Youngblood, Didier Kiyali, and Shawn McFee, Catalent

Pharmaceutical fill formulations that exist as a solid-like or semi-solid systems at room temperature and melt at temperatures greater than 40C typically do not lend themselves readily to encapsulation using traditional gelatin-based encapsulation films; that’s because during capsule formation the films have a sealing limit of approximately 38-42 C. Now novel, polysaccharide-based softgel shell compositions have been developed that, in conjunction with “hot filling” processing techniques, are suitable for the encapsulation of fill formulation that are highly viscous or semi-solid at room temperature.

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