Invention Grant
- Patent Title: Stable, highly pure L-cysteine compositions for injection and methods of use
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Application No.: US16746028Application Date: 2020-01-17
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Publication No.: US10933089B1Publication Date: 2021-03-02
- Inventor: John Maloney , Aruna Koganti , Phanesh Koneru
- Applicant: Exela Pharma Sciences, LLC
- Applicant Address: US NC Lenoir
- Assignee: Exela Pharma Sciences, LLC
- Current Assignee: Exela Pharma Sciences, LLC
- Current Assignee Address: US NC Lenoir
- Agency: Alston & Bird LLP
- Main IPC: A61K33/06
- IPC: A61K33/06 ; A61K31/191 ; A23L33/16 ; A61K31/198 ; A61K31/095 ; A61K33/28 ; A61K33/00 ; A61K31/401 ; A61K31/405 ; A61K33/241 ; A61K47/02 ; A61K31/4172 ; A23L33/175 ; A61K9/00 ; A61K33/36 ; A61J1/14

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.
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