Claims for Patent: 10,548,859

Summary for Patent: 10,548,859

Title:	Methods for storing Cysteamine formulations and related methods of treatment
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.
Inventor(s):	Desjardin; Michael (Aptos, CA), Johnson; Mark (Fort Collins, CO)
Assignee:	Horizon Orphan LLC (Lake Forest, IL)
Application Number:	16/402,599
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,548,859
Patent Claims:	1. A method of treating nephropathic 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.degree. C. and about 8.degree. 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.degree. C. and about 25.degree. C. 2. The method according to claim 1, wherein the oral pharmaceutical composition further comprises an enteric coating wherein the enteric coating comprises poly(methacrylic acid co-ethyl acrylate) 1:1. 3. The method according to claim 1, wherein the oral pharmaceutical composition contains 2-hydroxythiomorpholine in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for a period of up to 15 months. 4. The method according to claim 1, wherein the oral pharmaceutical composition contains 2-hydroxythiomorpholine in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 25.degree. C. and 60% relative humidity for a period of up to 3 months. 5. The method according to claim 1, wherein the oral pharmaceutical composition contains 2-hydroxythiomorpholine in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 65% relative humidity for a period of up to 3 months. 6. The method according to claim 1, wherein the oral pharmaceutical composition contains 2-hydroxythiomorpholine in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 70% relative humidity for a period of up to 3 months. 7. A method of treating nephropathic 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.degree. C. and about 8.degree. 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.degree. C. and about 25.degree. C. 8. The method according to claim 7, wherein the oral pharmaceutical composition further comprises an enteric coating, wherein the enteric coating comprises poly(methacrylic acid co-ethyl acrylate) 1:1. 9. The method according to claim 7, wherein the oral pharmaceutical composition contains cystamine in an amount less than 4% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for a period of up to 15 months. 10. The method according to claim 7, wherein the oral pharmaceutical composition contains cystamine in an amount less than 4% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 25.degree. C. and 60% relative humidity for a period of up to 3 months. 11. The method according to claim 7, wherein the oral pharmaceutical composition contains cystamine in an amount less than 4% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 65% relative humidity for a period of up to 3 months. 12. The method according to claim 7, wherein the oral pharmaceutical composition contains cystamine in an amount less than 4% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 70% relative humidity for a period of up to 3 months. 13. A method of treating nephropathic 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.degree. C. and about 8.degree. 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.degree. C. and about 25.degree. C. 14. The method according to claim 13, wherein the oral pharmaceutical composition further comprises an enteric coating, wherein the enteric coating comprises poly(methacrylic acid co-ethyl acrylate) 1:1. 15. The method according to claim 13, wherein the oral pharmaceutical composition contains cystamine tartrate amide in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for a period of up to 15 months. 16. The method according to claim 13, wherein the oral pharmaceutical composition contains cystamine tartrate amide in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 25.degree. C. and 60% relative humidity for a period of up to 3 months. 17. The method according to claim 13, wherein the oral pharmaceutical composition contains cystamine tartrate amide in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 65% relative humidity for a period of up to 3 months. 18. The method according to claim 13, wherein the oral pharmaceutical composition contains cystamine tartrate amide in an amount less than 0.5% relative to the amount of cysteamine bitartrate when the oral pharmaceutical composition is stored at a temperature of between about 2.degree. C. and about 8.degree. C. for an initial period of up to 15 months, and wherein the oral pharmaceutical composition is subsequently stored at a temperature of 30.degree. C. and 70% relative humidity for a period of up to 3 months.