Claims for Patent: 11,969,439

Summary for Patent: 11,969,439

Title:	Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	John Maloney, Aruna Koganti, Phanesh Koneru
Assignee:	Exela Pharma Sciences LLC
Application Number:	US18/520,172
Patent Claims:	1. A method of treating a subject having an adverse health condition that is responsive to L-cysteine administration, said method comprising: parenterally administering to the subject a composition, the composition comprising: a solution comprising L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; Aluminum; and, a pharmaceutically acceptable carrier; wherein the ratio of L-cysteine to Aluminum is from about 35,000,000 to about 140,000:1 for at least 6 months from the time of manufacture of the solution; and, wherein the solution: has a pH from about 1.0 to about 2.5; is substantially free of visually detectable particulate matter; and, the solution provides not more than 3 mcg/kg/day of aluminum. 2. The method of claim 1, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 3. The method of claim 1, wherein the ratio is from about 700,000:1 to about 140,000:1. 4. The method of claim 1, wherein the ratio is from about 170,000:1 to about 140,000:1. 5. The method of claim 1, wherein the composition further comprises one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine, and the composition provides not more than 5 mcg/kg/day of aluminum. 6. The method of claim 5, wherein the composition provides not more than 4 mcg/kg/day of aluminum. 7. The method of claim 5, wherein the composition comprises about 15-40 mg L-cysteine per gram of the one or more amino acids. 8. The method of claim 5, wherein the adverse health condition is the need for total parenteral nutrition (TPN). 9. A method of treating a subject having an adverse health condition that is responsive to L-cysteine administration, said method comprising: parenterally administering to said subject a composition, the composition comprising: a solution comprising L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; Aluminum; and, a pharmaceutically acceptable carrier; wherein the ratio of L-cysteine to Aluminum is from about 35,000,000 to about 140,000:1 for at least 9 months from the time of manufacture of the solution; and, wherein the solution: has a pH from about 1.0 to about 2.5; is substantially free of visually detectable particulate matter; and, the solution provides not more than 3 meg/kg/day of aluminum. 10. The method of claim 9, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 11. The method of claim 9, wherein the ratio is from about 700,000:1 to about 140,000:1. 12. The method of claim 9, wherein the ratio is from about 170,000:1 to about 140,000:1. 13. The method of claim 9, wherein the composition further comprises one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine, and the composition provides not more than 5 mcg/kg/day of aluminum. 14. The method of claim 13, wherein the composition provides not more than 4 mcg/kg/day of aluminum. 15. The method of claim 13, wherein the composition comprises about 15-40 mg L-cysteine per gram of the one or more amino acids. 16. The method of claim 13, wherein the adverse health condition is the need for total parenteral nutrition (TPN). 17. A method of treating a subject having an adverse health condition that is responsive to L-cysteine administration, said method comprising: parenterally administering to said subject a composition, the composition comprising: a solution comprising L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; Aluminum; and, a pharmaceutically acceptable carrier; wherein the ratio of L-cysteine to Aluminum is from about 35,000,000 to about 140,000:1 for at least 12 months from the time of manufacture of the solution; and, wherein the solution: has a pH from about 1.0 to about 2.5; is substantially free of visually detectable particulate matter; and, the solution provides not more than 3 mcg/kg/day of aluminum. 18. The method of claim 17, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 19. The method of claim 17, wherein the ratio is from about 700,000:1 to about 140,000:1. 20. The method of claim 17, wherein the ratio is from about 170,000:1 to about 140,000:1. 21. The method of claim 17, wherein the composition further comprises one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine, and the composition provides not more than 5 meg/kg/day of aluminum. 22. The method of claim 21, wherein the composition provides not more than 4 mcg/kg/day of aluminum. 23. The method of claim 21, wherein the composition comprises about 15-40 mg L-cysteine per gram of the one or more amino acids. 24. The method of claim 21, wherein the adverse health condition is the need for total parenteral nutrition (TPN). 25. A method of treating a subject having an adverse health condition that is responsive to L-cysteine administration, said method comprising: parenterally administering to the subject a composition, the composition comprising: a solution comprising L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; Aluminum; and, a pharmaceutically acceptable carrier; wherein the ratio of L-cysteine to Aluminum is from about 35,000,000 to about 140,000:1 for at least 18 months from the time of manufacture of the solution; and, wherein the solution: has a pH from about 1.0 to about 2.5; is substantially free of visually detectable particulate matter; and, the solution provides not more than 3 meg/kg/day of aluminum. 26. The method of claim 25, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 27. The method of claim 25, wherein the ratio is from about 170,000:1 to about 140,000:1. 28. The method of claim 24, wherein the composition further comprises one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenylalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine, and the composition provides not more than 5 mcg/kg/day of aluminum. 29. The method of claim 28, wherein the composition comprises about 15-40 mg L-cysteine per gram of the one or more amino acids. 30. The method of claim 28, wherein the adverse health condition is the need for total A parenteral nutrition (TPN).