Claims for Patent: 10,702,490

Summary for Patent: 10,702,490

Title:	Cysteine composition and injection
Abstract:	Cysteine compositions comprising less than about 400 .mu.g/L of aluminum. For example, solutions of cysteine comprising a pharmaceutically acceptable solvent, cysteine, and less than about 145 .mu.g/L of aluminum, wherein the solution is devoid of visible particulate matter. Cysteine compositions described herein may be suitable for injection. For example, disclosed cysteine solutions may be provided intravenously to meet amino acid nutritional requirement in individuals receiving total parenteral nutrition. Also provided are processes for preparing cysteine compositions, and methods for providing cysteine to individuals in need thereof.
Inventor(s):	Sutterer; Angela (Chesterfield, MO), Simpson; Jill (Chesterfield, MO), Pouliquen; Gauthier (Ternay, FR), Constancis; Alain (Lyons, FR), Danner; Pierre (Francheville, FR)
Assignee:	Avadel Legacy Pharmaceuticals, LLC (Chesterfield, MO)
Application Number:	16/677,379
Patent Claims:	1. A cysteine hydrochloride solution comprising about 40 mg/mL to about 60 mg/mL of cysteine hydrochloride and a pH from about 1.0 to about 1.5, wherein preparation of the cysteine hydrochloride solution comprises: acidifying water to a pH from about 1.0 to about 1.5 to form acidified water; dissolving about 40 mg to about 60 mg of cysteine hydrochloride per 1 mL of acidified water to form a solution; and filling and sealing a container in which the solution is disposed under flow of an inert gas. 2. The cysteine hydrochloride solution of claim 1, which is free of visible particulate matter. 3. The cysteine hydrochloride solution of claim 1, which is free of visible particulate matter when stored for at least six months at 25.degree. C. and 60% relative humidity. 4. The cysteine hydrochloride solution of claim 1, which is free of visible particulate matter when stored for at least 12 months at 25.degree. C. and 60% relative humidity. 5. The cysteine hydrochloride solution of claim 1, which is free of visible particulate matter when stored for at least 18 months at 25.degree. C. and 60% relative humidity. 6. The cysteine hydrochloride solution of claim 1, which is free of visible particulate matter when stored for at least 24 months at 25.degree. C. and 60% relative humidity. 7. The cysteine hydrochloride solution of claim 1, which has a cystine content of less than about 1% by weight of the total cysteine present in the cysteine hydrochloride solution. 8. The cysteine hydrochloride solution of claim 1, which has a dissolved oxygen content of less than 2 mg/L. 9. The cysteine hydrochloride solution of claim 1, wherein the pH of the cysteine hydrochloride solution is from about 1.0 to about 1.4. 10. The cysteine hydrochloride solution of claim 1, wherein the pH of the cysteine hydrochloride solution is from about 1.0 to about 1.3. 11. The cysteine hydrochloride solution of claim 1, wherein the pH of the cysteine hydrochloride solution is from about 1.0 to about 1.2. 12. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 200 .mu.g/L. 13. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 145 .mu.g/L. 14. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 100 .mu.g/L. 15. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 30 .mu.g/L. 16. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 10 .mu.g/L. 17. The cysteine hydrochloride solution of claim 1, having an aluminum content from about 0 .mu.g/L to about 100 .mu.g/L. 18. The cysteine hydrochloride solution of claim 1, having an aluminum content from about 0 .mu.g/L to about 30 .mu.g/L. 19. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 145 .mu.g/L when stored for at least six months at 25.degree. C. and 60% relative humidity. 20. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 145 .mu.g/L when stored for at least 12 months at 25.degree. C. and 60% relative humidity. 21. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 145 .mu.g/L when stored for at least 18 months at 25.degree. C. and 60% relative humidity. 22. The cysteine hydrochloride solution of claim 1, having an aluminum content of less than about 145 .mu.g/L when stored for at least 24 months at 25.degree. C. and 60% relative humidity. 23. The cysteine hydrochloride solution of claim 1, which comprises about 50 mg/mL of cysteine hydrochloride. 24. The cysteine hydrochloride solution of claim 1, wherein the acidifying is performed under flow of an inert gas. 25. The cysteine hydrochloride solution of claim 1, wherein the preparation of the cysteine hydrochloride solution further comprises sparging water with an inert gas to achieve a dissolved oxygen content of less than 2 mg/L in the water prior to the acidifying. 26. The cysteine hydrochloride solution of claim 1, wherein the dissolving comprises stirring under flow of an inert gas. 27. The cysteine hydrochloride solution of claim 1, wherein the preparation of the cysteine hydrochloride solution further comprises sterile filtering the solution prior to the filling and sealing. 28. The cysteine hydrochloride solution of claim 27, wherein the sterile filtering comprises passing the solution through at least one 0.22 .mu.m filter. 29. The cysteine hydrochloride solution of claim 1, wherein the acidifying, the dissolving, and the filling and sealing are performed at ambient temperature. 30. The cysteine hydrochloride solution of claim 1, wherein the container is a silica-lined glass vial.