Claims for Patent: 11,510,941

Summary for Patent: 11,510,941

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:	US17/164,263
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,510,941
Patent Claims:	1. A solution of L-cysteine 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; not more than 200 ppb of aluminum for at least 6 months from the time of manufacture of the solution; not more than 2.0% L-cystine relative to L-cysteine; and, a pharmaceutically acceptable carrier; 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 use as an additive in a parenteral nutrition composition for administration to an individual. 2. The solution of claim 1, wherein the L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof is present in an amount from about 20 mg/mL to about 80 mg/mL. 3. The solution of claim 1, wherein the L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof is present in an amount from about 30 mg/mL to about 70 mg/mL. 4. The solution of claim 1, wherein the L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof is present in an amount from about 40 mg/mL to about 60 mg/mL. 5. The solution of claim 1, wherein the L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof is present in an amount of about 50 mg/mL. 6. The solution of claim 1, comprising not more than 150 ppb of aluminum for at least 12 months from the time of manufacture of the solution. 7. The solution of claim 1, comprising not more than 120 ppb of aluminum for at least 12 months from the time of manufacture of the solution. 8. The solution of claim 1, comprising not more than 100 ppb of aluminum for at least 12 months from the time of manufacture of the solution. 9. The solution of claim 1, comprising not more than 80 ppb of aluminum for at least 12 months from the time of manufacture of the solution. 10. The solution of claim 1, comprising not more than 1.0% L-cystine relative to L-cysteine. 11. The solution of claim 1, which has a dissolved oxygen content of less than 2 ppm. 12. The solution of claim 1, which has a dissolved oxygen content of less than 1 ppm. 13. The solution of claim 1, wherein the pharmaceutically acceptable carrier is aqueous. 14. The solution of claim 1, comprising not more than 200 ppb of aluminum for at least 12 months from the time of manufacture of the solution. 15. A solution of L-cysteine comprising, L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount of about 50 mg/mL; not more than 120 ppb of aluminum for at least 6 months from the time of manufacture of the solution; not more than 1.0% L-cystine relative to L-cysteine; and, a pharmaceutically acceptable carrier; and, wherein the solution: has a pH from about 1.0 to about 2.5; has a dissolved oxygen content of less than 1 ppm; is substantially free of visually detectable particulate matter; and, is suitable for use as an additive in a parenteral nutrition composition for administration to an individual. 16. A method of preparing a L-cysteine solution comprising, preparing a mixture of a pharmaceutically acceptable carrier comprising less than about 1 ppm dissolved oxygen and L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof; adjusting the pH of said mixture to from about 1.0 to about 2.5; transferring an amount of the pH-adjusted mixture into a single-use container; reducing the headspace oxygen in the container; and, sealing the container, wherein, the L-cysteine solution comprises: 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; not more than 200 ppb of aluminum for at least 6 months from the time of manufacture of the solution; not more than 2.0% L-cystine relative to L-cysteine; and, a pharmaceutically acceptable carrier; 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 use as an additive in a parenteral nutrition composition for administration to an individual. 17. The method of claim 16, wherein the L-cysteine solution comprises: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount of about 50 mg/mL; not more than 120 ppb of aluminum for at least 6 months from the time of manufacture of the solution; not more than 1.0% L-cystine relative to L-cysteine; and, a pharmaceutically acceptable carrier; and, wherein the solution: has a pH from about 1.0 to about 2.5; has a dissolved oxygen content of less than 1 ppm; is substantially free of visually detectable particulate matter particulate matter; and, is suitable for use as an additive in a parenteral nutrition composition for administration to an individual.