Claims for Patent: 10,493,051

Summary for Patent: 10,493,051

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:	Flamel Ireland Limited (Dublin, IE)
Application Number:	16/355,028
Patent Claims:	1. A solution of cysteine comprising a pharmaceutically acceptable solvent, about 50 mg/mL of cysteine, less than about 400 .mu.g/L of aluminum, and a pH from about 1.0 to about 2.5, wherein the solution is suitable for use as an additive in a total parenteral nutrition formulation for a neonate or an infant. 2. The solution of claim 1, which comprises less than about 145 .mu.g/L of aluminum. 3. The solution of claim 2, which comprises less than about 100 .mu.g/L of aluminum. 4. The solution of claim 3, which comprises less than about 30 .mu.g/L of aluminum. 5. The solution of claim 4, which comprises less than about 10 .mu.g/L of aluminum. 6. The solution of claim 1, which comprises from about 1 .mu.g/L to about 145 .mu.g/L of aluminum. 7. The solution of claim 1, wherein the pH is from about 1.0 to about 1.5. 8. The solution of claim 7, wherein the pH is from about 1.0 to about 1.3. 9. The solution of claim 8, which has a dissolved oxygen content of less than 2 mg per liter. 10. The solution of claim 9, which is devoid of visible particulate matter. 11. The solution of claim 9, which is devoid of precipitated particles of cystine. 12. The solution of claim 1, wherein the pharmaceutically acceptable solvent is water. 13. The solution of claim 1, which comprises cysteine hydrochloride. 14. The solution of claim 13, which comprises cysteine hydrochloride monohydrate. 15. The solution of claim 1, which comprises less than about 400 .mu.g/L of aluminum when stored in a silica-lined vial for 18 months at 25.degree. C. and 60% relative humidity. 16. The solution of claim 1, which comprises less than about 400 .mu.g/L of aluminum when stored in a silica-lined vial for 6 months at 40.degree. C. and 75% relative humidity. 17. The solution of claim 9, which is devoid of visible particulate matter when stored for 18 months at 25.degree. C. and 60% relative humidity. 18. The solution of claim 9, which is devoid of visible particulate matter when stored for 6 months at 40.degree. C. and 75% relative humidity. 19. The solution of claim 1, which comprises less than about 145 .mu.g/L of aluminum, and is devoid of visible particulate matter. 20. The solution of claim 19, which comprises cysteine hydrochloride monohydrate. 21. A solution of cysteine having a cysteine content of at least 99% by weight and a cystine content of less than 1% by weight, wherein the solution has a dissolved oxygen content of less than about 2 mg/L, a pH from about 1.0 to about 1.5, and a cysteine hydrochloride concentration of about 50 mg/mL. 22. The solution of claim 21, wherein the cystine content is less than about 0.5% by weight. 23. The solution of claim 21, which is devoid of precipitated particles of cystine. 24. The solution of claim 21, which has an aluminum content of less than about 400 .mu.g/L. 25. The solution of claim 24, wherein the aluminum content is less than about 145 .mu.g/L. 26. A solution of cysteine, wherein the solution comprises 50 mg/mL of cysteine hydrochloride monohydrate in water adjusted to pH 1.0 to 2.5, the solution contains less than 145 .mu.g/L of aluminum, and the solution is designed to be parenterally administered as part of a total parenteral nutrition injection to a neonate or an infant. 27. A solution of cysteine, wherein the solution comprises 50 mg/mL of cysteine hydrochloride monohydrate in water adjusted to pH 1.0 to 2.5, the solution contains less than 145 .mu.g/L of aluminum, and the solution is designed to be parenterally administered as part of a total parenteral nutrition injection to an individual with severe liver disease who has impairment in the enzymatic conversion of cysteine.