- 专利标题: Stable, highly pure L-cysteine compositions for injection and methods of use
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申请号: US17188922申请日: 2021-03-01
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公开(公告)号: US11510942B1公开(公告)日: 2022-11-29
- 发明人: John Maloney , Aruna Koganti , Phanesh Koneru
- 申请人: Exela Pharma Sciences, LLC
- 申请人地址: US NC Lenoir
- 专利权人: Exela Pharma Sciences, LLC
- 当前专利权人: Exela Pharma Sciences, LLC
- 当前专利权人地址: US NC Lenoir
- 代理机构: Alston & Bird LLP
- 主分类号: A61K31/4172
- IPC分类号: A61K31/4172 ; A61K33/06 ; A61K31/191 ; A61K47/02 ; A61K33/36 ; A61K33/241 ; A61K33/28 ; A61K33/00 ; A61K31/405 ; A61K31/401 ; A61K9/00 ; A23L33/175 ; A23L33/16 ; A61K31/198 ; A61K31/095 ; A61J1/14
摘要:
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; cysteine 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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