Improved api stability in softgels
AssigneeR.P. Scherer Technologies, LLC
InventorsDouglas Keith DURHAM, Hitesh S. PATEL
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Abstract
Softgels having improved stability of active pharmaceutical ingredients and methods of preparing the same are provided. In some embodiments, a softgel comprises a fill material composition and a softgel shell. In some embodiments, the fill material composition of the softgel comprises one or more active pharmaceutical ingredient (API); 2 to 15 wt. % povidone; 30 to 60 wt. % polyethylene glycol; and 0.5 to 5 wt. % propylene glycol, wherein the fill material composition has a pH of 3.75 or less. In some embodiments, the softgel shell is made from a softgel shell composition comprising an acidic component.
Claims44
A pharmaceutical softgel comprising:
- a fill material composition comprising:
- one or more active pharmaceutical ingredient (API);
- 2 to 15 wt. % povidone;
- 30 to 60 wt. % polyethylene glycol;
- and
- 0.5 to 5 wt. % propylene glycol, wherein the fill material composition has a pH of 3.75 or less, and
- a softgel shell.
A fill material composition for a softgel comprising:
- one or more active pharmaceutical ingredients (APIs),
- 2 to 15 wt. % povidone,
- 30 to 60 wt. % polyethylene glycol, and
- 0.5 to 5 wt. % propylene glycol,
- wherein the fill material composition has a pH of 3.75 or less.
A method of preparing a fill material composition for a softgel comprising:
- combining 30 to 60 wt. % polyethylene glycol, 0.5 to 5 wt. % propylene glycol, 2 to 15 wt. % povidone, one or more active pharmaceutical ingredient (API), and an acidic component to achieve a pH of 3.75 or less of the fill material composition.
A method of preparing a softgel comprising:
- combining 30 to 60 wt. % polyethylene glycol, 0.5 to 5 wt. % propylene glycol, 2 to 15 wt. % povidone, one or more active pharmaceutical ingredient (API), and an acidic component to form a fill material comprising a pH of 3.75 or less;
- and
- encapsulating the fill material in a softgel shell to form a softgel.
Dependencies are inferred from the claim text.