Claims for Patent: 11,045,438

Summary for Patent: 11,045,438

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:	Exela Sterile Medicines LLC (Lenoir, NC)
Application Number:	16/658,873
Patent Claims:	1. A solution of cysteine comprising a pharmaceutically acceptable solvent, about 40 mg/mL to about 60 mg/mL of cysteine hydrochloride, less than about 200 .mu.g/L of aluminum, and a pH from about 1.0 to about 1.5, wherein the solution is devoid of visible particulate matter and 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 from 42.5 mg/mL to 57.5 mg/mL of cysteine hydrochloride monohydrate. 3. The solution of claim 1, which comprises about 50 mg/mL of cysteine hydrochloride monohydrate. 4. The solution of claim 1, which comprises less than about 145 .mu.g/L of aluminum. 5. The solution of claim 4, which comprises less than about 100 .mu.g/L of aluminum. 6. The solution of claim 5, which comprises less than about 30 .mu.g/L of aluminum. 7. The solution of claim 6, which comprises less than about 10 .mu.g/L of aluminum. 8. The solution of claim 1, which comprises from about 1 .mu.g/L to about 145 .mu.g/L of aluminum. 9. The solution of claim 1, which comprises from about 0 .mu.g/L to about 100 .mu.g/L of aluminum. 10. The solution of claim 1, wherein the pH is from about 1.0 to about 1.3. 11. The solution of claim 1, which has a dissolved oxygen content of less than 2 mg/L. 12. The solution of claim 1, which has a cystine content of less than about 1% by weight of the total cysteine present in the solution. 13. The solution of claim 1, wherein the pharmaceutically acceptable solvent is water. 14. A sterile solution of about 50 mg/mL of cysteine hydrochloride in water for injection, wherein the sterile solution has a pH from about 1.0 to about 1.5, an aluminum content of less than about 145 .mu.g/L, and is suitable for use as an additive in a total parenteral nutrition formulation for a neonate or an infant. 15. The sterile solution of claim 14, wherein the pH is from about 1.0 to about 1.3. 16. The sterile solution of claim 14, wherein the pH is from about 1.0 to about 1.2. 17. The sterile solution of claim 14, wherein the aluminum content is less than about 100 .mu.g/L. 18. The sterile solution of claim 14, wherein the aluminum content is less than about 30 .mu.g/L. 19. The sterile solution of claim 14, which comprises about 50 mg/mL of cysteine hydrochloride monohydrate. 20. The sterile solution of claim 14, which is devoid of visible particulate matter. 21. A cysteine hydrochloride composition for intravenous use comprising 500 mg of cysteine hydrochloride in 10 mL of water in a 10 mL vial, wherein the cysteine hydrochloride composition has a pH from about 1.0 to about 1.5 and an aluminum content of less than about 100 .mu.g/L. 22. The cysteine hydrochloride composition of claim 21, wherein the pH is from about 1.0 to about 1.3. 23. The cysteine hydrochloride composition of claim 21, wherein the aluminum content is less than about 30 .mu.g/L. 24. The cysteine hydrochloride composition of claim 21, wherein the pH is from about 1.0 to about 1.3 and the aluminum content is less than about 30 .mu.g/L. 25. A cysteine hydrochloride composition for intravenous use comprising 500 mg of cysteine hydrochloride in 10 mL of water in a 10 mL vial, wherein the cysteine hydrochloride composition has a pH from about 1.0 to about 1.5 and an aluminum content from about 0 .mu.g/L to about 100 .mu.g/L. 26. The cysteine hydrochloride composition of claim 25, wherein the pH is from about 1.0 to about 1.3. 27. The cysteine hydrochloride composition of claim 25, wherein the aluminum content is from about 0 .mu.g/L to about 30 .mu.g/L. 28. The cysteine hydrochloride composition of claim 25, wherein the pH is from about 1.0 to about 1.3 and the aluminum content is from about 0 .mu.g/L to about 30 .mu.g/L.