Claims for Patent: 11,826,383

Summary for Patent: 11,826,383

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:	US18/332,677
Patent Claims:	1. A solution of L-cysteine 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, is suitable for dilution and use as an admixture in a parenteral nutrition composition for administration to an individual. 2. The solution of claim 1, wherein the solution provides not more than 3 mcg/kg/day of aluminum. 3. The solution of claim 1, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 4. The solution of claim 1, wherein the ratio is from about 700,000:1 to about 140,000:1. 5. The solution of claim 1, wherein the ratio is from about 170,000:1 to about 140,000:1. 6. A parenteral nutrition composition comprising, the solution of claim 1; one or more amino acids selected from the group consisting of: leucine, isoleucine, lysine, valine, phenyalanine, histidine, threonine, methionine, tryptophan, alanine, arginine, glycine, proline, serine, and tyrosine; and, an intravenous fluid. 7. The parenteral nutrition composition of claim 6, comprising about 15-40 mg L-cysteine per gram of the one or more amino acids. 8. The parenteral nutrition composition of claim 7, comprising about 40 mg L-cysteine per gram of the one or more amino acids. 9. The parenteral nutrition composition of claim 6, wherein the composition provides not more than 5 mcg/kg/day of aluminum. 10. The parenteral nutrition composition of claim 9, wherein the composition provides not more than 4 mcg/kg/day of aluminum. 11. A solution of L-cysteine 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, is suitable for dilution and use as an admixture in a parenteral nutrition composition for administration to an individual. 12. The solution of claim 11, wherein the solution provides not more than 3 mcg/kg/day of aluminum. 13. The solution of claim 11, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 14. The solution of claim 11, wherein the ratio is from about 700,000:1 to about 140,000:1. 15. The solution of claim 11, wherein the ratio is from about 170,000:1 to about 140,000:1. 16. A parenteral nutrition composition comprising, the solution of claim 11; 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, an intravenous fluid. 17. The parenteral nutrition composition of claim 16, comprising 15-40 mg L-cysteine per gram of the one or more amino acids. 18. The parenteral nutrition composition of claim 17, comprising about 40 mg L-cysteine per gram of the one or more amino acids. 19. The parenteral nutrition composition of claim 16, wherein the composition provides not more than 5 mcg/kg/day of aluminum. 20. The solution of claim 19, wherein the parenteral nutrition composition provides not more than 4 mcg/kg/day of aluminum. 21. A solution of L-cysteine 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, is suitable for dilution and use as an admixture in a parenteral nutrition composition for administration to an individual. 22. The solution of claim 21, wherein the solution provides not more than 3 mcg/kg/day of aluminum. 23. The solution of claim 21, wherein the ratio is from about 1,800,000:1 to about 140,000:1. 24. The solution of claim 21, wherein the ratio is from about 700,000:1 to about 140,000:1. 25. The solution of claim 21, wherein the ratio is from about 170,000:1 to about 140,000:1. 26. A parenteral nutrition composition comprising, the solution of claim 21; 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, an intravenous fluid. 27. The parenteral nutrition composition of claim 26, comprising 15-40 mg L-cysteine per gram of the one or more amino acids. 28. The parenteral nutrition composition of claim 27, comprising about 40 mg L-cysteine per gram of the one or more amino acids. 29. The parenteral nutrition composition of claim 26, wherein the composition provides not more than 5 mcg/kg/day of aluminum. 30. The parenteral nutrition composition of claim 29, wherein the composition provides not more than 4 mcg/kg/day of aluminum.