公开(公告)号：US11266621B1

公开(公告)日：2022-03-08

申请号：US16953010

申请日：2020-11-19

申请人： Exela Pharma Sciences, LLC

发明人： Phanesh B. Koneru ,  John Maloney

IPC分类号： A61K31/27 ,  A61K9/00

摘要： Stable methocarbamol ready to use compositions for parenteral administration including parenteral infusion are provided. In certain embodiments, the compositions are sterile, isotonic, and particulate-matter-free. Further, the compositions reduce or avoid allergic reactions to latex, reduce or avoid extravasation, and permit administration of methocarbamol to subjects having renal pathology. Methods of manufacture and methods of administration are also provided.

公开(公告)号：US10912795B1

公开(公告)日：2021-02-09

申请号：US16850726

申请日：2020-04-16

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/06 ,  A61K31/095 ,  A61K31/401 ,  A61K31/405 ,  A61K47/02 ,  A61K33/241 ,  A61K9/00 ,  A61K33/36 ,  A61K33/00 ,  A23L33/175 ,  A61K33/28 ,  A23L33/16 ,  A61K31/198 ,  A61K31/4172 ,  A61K31/191 ,  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; 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.

公开(公告)号：US10583155B1

公开(公告)日：2020-03-10

申请号：US16665702

申请日：2019-10-28

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/06 ,  A61K33/241 ,  A61K31/401 ,  A23L33/16 ,  A23L33/175 ,  A61K31/405 ,  A61K31/095 ,  A61K9/00 ,  A61K33/00 ,  A61K47/02 ,  A61K31/191 ,  A61K31/198 ,  A61K31/4172 ,  A61K33/36 ,  A61K33/28 ,  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; 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.

公开(公告)号：US11679125B1

公开(公告)日：2023-06-20

申请号：US18067605

申请日：2022-12-16

申请人： EXELA PHARMA SCIENCES, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/08 ,  A61K33/06 ,  A23L33/16 ,  A61K31/191 ,  A61K9/00 ,  A61K31/405 ,  A61K31/095 ,  A23L33/175 ,  A61K31/198 ,  A61K31/4172 ,  A61K31/401 ,  A61K33/28 ,  A61K33/241 ,  A61K33/36 ,  A61K33/00 ,  A61K47/02 ,  A61J1/14

CPC分类号： A61K33/06 ,  A23L33/16 ,  A23L33/175 ,  A61K9/0029 ,  A61K31/095 ,  A61K31/191 ,  A61K31/198 ,  A61K31/401 ,  A61K31/405 ,  A61K31/4172 ,  A61K33/00 ,  A61K33/241 ,  A61K33/28 ,  A61K33/36 ,  A61K47/02 ,  A23V2002/00 ,  A61J1/1412

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; 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.

公开(公告)号：US10918662B1

公开(公告)日：2021-02-16

申请号：US16850973

申请日：2020-04-16

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/06 ,  A61K31/095 ,  A61K31/401 ,  A61K31/405 ,  A61K47/02 ,  A61K33/241 ,  A61K9/00 ,  A61K33/36 ,  A61K33/00 ,  A23L33/175 ,  A61K33/28 ,  A23L33/16 ,  A61K31/198 ,  A61K31/4172 ,  A61K31/191 ,  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; 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.

公开(公告)号：US20240181064A1

公开(公告)日：2024-06-06

申请号：US18233853

申请日：2023-08-14

申请人： Exela Pharma Sciences, LLC

发明人： Sreerama Murthy Mallipeddi ,  Jonathan E. Sterling ,  Phanesh B. Koneru

IPC分类号： A61K47/26 ,  A61K9/00 ,  A61K9/08 ,  A61K31/522 ,  A61K47/02 ,  A61K47/10

CPC分类号： A61K47/26 ,  A61K9/0019 ,  A61K9/08 ,  A61K31/522 ,  A61K47/02 ,  A61K47/10

摘要： Gancyclovir formulations that are ready-to-use, substantially particulate free, and stable upon storage are disclosed. Methods of manufacture and administration of such compositions are also provided.

公开(公告)号：US11826383B1

公开(公告)日：2023-11-28

申请号：US18332677

申请日：2023-06-09

申请人： EXELA PHARMA SCIENCES, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/06 ,  A61K31/191 ,  A61K47/02 ,  A61K33/36 ,  A61K33/241 ,  A61K33/28 ,  A61K33/00 ,  A61K31/405 ,  A61K31/401 ,  A61K31/4172 ,  A61K9/00 ,  A23L33/175 ,  A23L33/16 ,  A61K31/198 ,  A61K31/095 ,  A61J1/14

CPC分类号： A61K33/06 ,  A23L33/16 ,  A23L33/175 ,  A61K9/0029 ,  A61K31/095 ,  A61K31/191 ,  A61K31/198 ,  A61K31/401 ,  A61K31/405 ,  A61K31/4172 ,  A61K33/00 ,  A61K33/241 ,  A61K33/28 ,  A61K33/36 ,  A61K47/02 ,  A23V2002/00 ,  A61J1/1412

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; 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.

公开(公告)号：US11510942B1

公开(公告)日：2022-11-29

申请号：US17188922

申请日：2021-03-01

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

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.

公开(公告)号：US11510941B1

公开(公告)日：2022-11-29

申请号：US17164263

申请日：2021-02-01

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

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; 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.

公开(公告)号：US10905713B2

公开(公告)日：2021-02-02

申请号：US16773641

申请日：2020-01-27

申请人： Exela Pharma Sciences, LLC

发明人： John Maloney ,  Aruna Koganti ,  Phanesh Koneru

IPC分类号： A61K33/06 ,  A61K31/191 ,  A61K47/02 ,  A61K33/36 ,  A61K33/241 ,  A61K33/28 ,  A61K33/00 ,  A61K31/405 ,  A61K31/401 ,  A61K31/4172 ,  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; 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.