Claims for Patent: 11,510,941
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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 Othat 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): | Maloney John, Koganti Aruna, Koneru Phanesh |
| Assignee: | EXELA PHARMA SCIENCES, LLC |
| Application Number: | US17164263 |
| Patent Claims: |
