Radiation sterilization of hypercompresed 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.
Claims18
A sterile pharmaceutical dosage form which comprises an ester capped lactide polymer, an ester capped glycolide polymer or an ester capped lactide-glycolide copolymer that is hypercompressed with an active pharmaceutical ingredient selected from the group consisting of dexamethasone, prednisone, methyl prednisolone, latanoprost, unoprostone, bimatoprost, travoprost, timolol, carteolol, betaxolol, nadolol, levobuolol, dorzolamide and acetozolamide 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, an ester capped glycolide polymer or an ester capped lactide-glycolide copolymer which comprises:
- (a) combining an active pharmaceutical ingredient selected from the group consisting of dexamethasone, prednisone, methyl prednisolone, latanoprost, unoprostone, bimatoprost, travoprost, timolol, carteolol, betaxolol, nadolol, levobuolol, dorzolamide and acetozolamide 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 hypercompressed 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.