Methods for storing cysteamine formulations and related methods of treatment
AssigneeHorizon Orphan LLC
InventorsMichael Desjardin, Mark Johnson
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Abstract
Methods of storing and methods of stabilizing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, are provided. Methods of distributing pharmaceutical compositions comprising cysteamine, or a pharmaceutically acceptable salt thereof, and methods of treating cystinosis also are provided.
Claims24
A method of treating cystinosis in a subject in need thereof, comprising
- administering twice daily to the subject an oral pharmaceutical composition comprising cysteamine bitartrate,
- wherein the oral pharmaceutical composition contains 2-hydroxythiomorpholine in an amount less than 0.5% relative to the amount of cysteamine bitartrate,
- wherein the oral pharmaceutical composition was stored by a manufacturer, a distributor, a pharmacy, or a hospital at a temperature of between about 2° C. and about 8° C. prior to dispensing the oral pharmaceutical composition to the subject, and
- wherein after the oral pharmaceutical composition is dispensed to the subject, the oral pharmaceutical composition is stored at a temperature of between about 20° C. and about 25° C.
A method of treating cystinosis in a subject in need thereof, comprising
- administering twice daily to the subject an oral pharmaceutical composition comprising cysteamine bitartrate,
- wherein the oral pharmaceutical composition contains cystamine in an amount less than 4% relative to the amount of cysteamine bitartrate,
- wherein the oral pharmaceutical composition was stored by a manufacturer, a distributor, a pharmacy, or a hospital at a temperature of between about 2° C. and about 8° C. prior to dispensing the oral pharmaceutical composition to the subject, and
- wherein after the oral pharmaceutical composition is dispensed to the subject, the oral pharmaceutical composition is stored at a temperature of between about 20° C. and about 25° C.
A method of treating cystinosis in a subject in need thereof, comprising
- administering twice daily to the subject an oral pharmaceutical composition comprising cysteamine bitartrate,
- wherein the pharmaceutical composition contains cystamine tartrate amide in an amount less than 0.5% relative to the amount of cysteamine bitartrate,
- wherein the oral pharmaceutical composition was stored by a manufacturer, a distributor, a pharmacy, or a hospital at a temperature of between about 2° C. and about 8° C. prior to dispensing the oral pharmaceutical composition to the subject, and
- wherein after the oral pharmaceutical composition is dispensed to the subject, the oral pharmaceutical composition is stored at a temperature of between about 20° C. and about 25° C.
A method of treating cystinosis in a subject in need thereof, comprising
- administering twice daily to the subject an oral pharmaceutical composition comprising cysteamine bitartrate,
- wherein the pharmaceutical composition contains 2-hydroxymethylthiazolidine in an amount less than 0.05% relative to the amount of cysteamine bitartrate,
- wherein the oral pharmaceutical composition was stored by a manufacturer, a distributor, a pharmacy, or a hospital at a temperature of between about 2° C. and about 8° C. prior to dispensing the oral pharmaceutical composition to the subject, and
- wherein after the oral pharmaceutical composition is dispensed to the subject, the oral pharmaceutical composition is stored at a temperature of between about 20° C. and about 25° C.
Dependencies are inferred from the claim text.