Claims for Patent: 10,543,186

Summary for Patent: 10,543,186

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:	16/373,255
Patent Claims:	1. A method of using a cysteine solution, wherein the cysteine solution i) comprises cysteine hydrochloride in water for injection, ii) has a pH from about 1.0 to about 2.5, iii) has an aluminum content of less than about 145 micrograms per liter, and iv) is devoid of visible particulate matter, and wherein the method comprises: (a) diluting the cysteine solution; and (b) intravenously administering the diluted cysteine solution to a patient in need thereof. 2. The method of claim 1, wherein the aluminum content of the cysteine solution is less than about 125 micrograms per liter. 3. The method of claim 1, wherein the diluting comprises diluting the cysteine solution with saline, water for injection, an amino acid solution, or a combination thereof. 4. The method of claim 1, wherein the diluting comprises mixing the cysteine solution with an amino acid solution. 5. The method of claim 4, wherein the diluted cysteine solution comprises about 10-50 milligrams of cysteine per gram of amino acid. 6. The method of claim 1, wherein diluted cysteine solution further comprises electrolytes. 7. The method of claim 1, wherein the patient has severe liver disease. 8. The method of claim 1, wherein the patient is i) unable to receive feeding or fluid by mouth or ii) is unable to absorb nutrients through the gastrointestinal tract. 9. The method of claim 1, wherein the patient is an infant. 10. The method of claim 4, wherein cysteine makes up 2.2% of the total amino acid content of said diluted cysteine solution. 11. The method of claim 1, wherein the intravenously administering occurs within 24 hours of the diluting. 12. The method of claim 1, further comprising refrigerating the diluted cysteine solution prior to the intravenously administering. 13. The method of claim 1, wherein the L-cysteine solution has been passed through at least one 0.22 .mu.m filter. 14. A method of using a cysteine solution, wherein the cysteine solution i) comprises a pharmaceutically acceptable solvent, ii) has a cysteine hydrochloride concentration of about 50 milligrams per milliliter, iii) has a pH from about 1.0 to about 1.5, iv) has an aluminum content of less than about 200 micrograms per liter, and v) is devoid of visible particulate matter due, at least in part, to the pH being from about 1.0 to about 1.5, and wherein the method comprises: (a) diluting the cysteine solution with saline, water for injection, an amino acid solution, or a combination thereof; and (b) intravenously administering the diluted cysteine solution to a patient in need thereof, wherein the patient is i) a neonate or infant, ii) unable to receive feeding or fluid by mouth, iii) unable to absorb nutrients through the gastrointestinal tract, or iv) has severe liver disease. 15. The method of claim 14, wherein the aluminum content of the cysteine solution is less than about 145 micrograms per liter. 16. The method of claim 14, wherein the diluting comprises mixing the cysteine solution with an amino acid solution. 17. The method of claim 16, wherein the diluted cysteine solution comprises from about 10-50 milligrams of cysteine per gram of amino acid. 18. The method of claim 14, wherein diluted cysteine solution further comprises electrolytes. 19. A method of using a cysteine solution having a monomeric cysteine content of at least 99% by weight of total cysteine present in the solution and a dimeric cystine content of less than 1% by weight of total cysteine present in the solution, wherein the cysteine solution has a dissolved oxygen content of less than about 2 mg/L, a pH from about 1.0 to about 2.5, and is devoid of visible particulate matter, and wherein the method comprises: (a) diluting the cysteine solution with saline, water for injection, an amino acid solution, or a combination thereof; and (b) parenterally administering the diluted cysteine solution to a patient in need thereof, wherein the patient is i) a neonate or infant, ii) unable to receive feeding or fluid by mouth, iii) unable to absorb nutrients through the gastrointestinal tract, or iv) has severe liver disease. 20. The method of claim 19, where the cysteine solution contains less than about 145 micrograms of aluminum per liter. 21. The method of claim 19, wherein the cysteine solution comprises cysteine hydrochloride monohydrate in water for injection. 22. The method of claim 19, wherein the diluting comprises diluting the cysteine solution with an amino acid solution. 23. The method of claim 22, wherein the diluted cysteine solution comprises from about 10-50 milligrams of cysteine per gram of amino acid. 24. The method of claim 19, wherein the parenterally administering occurs within 24 hours of the diluting. 25. The method of claim 19, further comprising refrigerating the diluted cysteine solution prior to the parenterally administering. 26. The method of claim 19, wherein the cysteine solution has a pH from about 1.0 to about 1.5 prior to the diluting. 27. The method of claim 19, wherein the diluted cysteine solution parenterally administered further comprises electrolytes. 28. The method of claim 19, wherein the diluted cysteine solution parenterally administered further comprises sugars, vitamins, trace minerals, lipids, or a combination thereof.