Radiation sterilization of hypercompressed polymer dosage forms
AssigneeSustained Nano Systems LLC
InventorsBarry M. Libin, Jeffrey M. Liebmann, Weiliam Chen
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Abstract
A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, glycolide polymer or a lactide-glycolide copolymer hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam and a method of preparing said sterile pharmaceutical dosage form.
Claims13
A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, ester capped glycolide polymer or an ester capped lactide-glycolide copolymer that is hypercompressed with an active pharmaceutical ingredient wherein said sterile pharmaceutical dosage form has been sterilized with an electron beam.
A method of preparing a sterile hypercompressed pharmaceutical dosage form of an ester capped lactide polymer, ester capped glycolide polymer or an ester capped lactide-glycolide copolymer which comprises:
- (a) combining an active pharmaceutical ingredient with an ester capped lactide polymer, an ester capped glycolide polymer or an ester capped lactide-glycolide copolymer to form a powdered product;
- (b) hypercompressing the powdered product of step (a) to form a hypercompresed dosage form;
- and
- (c) exposing the hypercompressed dosage form of step (b) to a sterilizing amount of an E-beam radiation source to form a sterilized product.
Dependencies are inferred from the claim text.