Reduction of cross-linking gelatin in gelatin capsules
AssigneeIVAX Pharmaceuticals s.r.o.
InventorsAle{hacek over (s)} Vrána, Tomá{hacek over (s)} Andrýsek, Alexandr Jegorov, Richard Szrajber
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Abstract
The invention relates to compositions and methods for reducing cross-linking in the gelatin shell of gelatin capsules by incorporation of free amino acid into the capsule shell and by inclusion of an ester of carboxylic acid either into the capsule filling, and/or into the capsule shell and/or into the lubrication agent, or in combinations thereof. Described are soft gelatin capsules characterized by improved stability as compared with gelatin capsules that do not contain amino acid in the shell and carboxylic acid ester in the filling, shell or in the lubrication agent, or in combinations thereof.
Claims19
A gelatin capsule comprising a fill and a gelatin shell, wherein the gelatin shell comprises an amino-acid moiety cross linking inhibitor, and wherein the fill comprises a cross-linking inhibitor enhancer, wherein the enhancer is a carboxylic acid ester in an amount of from 0.01 to 10% (w/w) based on the weight of the fill, and wherein the gelatin capsule is adapted for oral administration.
Dependencies are inferred from the claim text.