AU2015222150B2 - Process for producing a stable low concentration, injectable solution of noradrenaline - Google Patents

Process for producing a stable low concentration, injectable solution of noradrenaline Download PDF

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Publication number
AU2015222150B2
AU2015222150B2 AU2015222150A AU2015222150A AU2015222150B2 AU 2015222150 B2 AU2015222150 B2 AU 2015222150B2 AU 2015222150 A AU2015222150 A AU 2015222150A AU 2015222150 A AU2015222150 A AU 2015222150A AU 2015222150 B2 AU2015222150 B2 AU 2015222150B2
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AU
Australia
Prior art keywords
noradrenaline
solution
injectable
stable
inert gas
Prior art date
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Active
Application number
AU2015222150A
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English (en)
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AU2015222150A1 (en
Inventor
Nicola CARONZOLO
Elisabetta Donati
Augusto Mitidieri
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Sintetica SA
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Sintetica SA
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50693780&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2015222150(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sintetica SA filed Critical Sintetica SA
Publication of AU2015222150A1 publication Critical patent/AU2015222150A1/en
Application granted granted Critical
Publication of AU2015222150B2 publication Critical patent/AU2015222150B2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/04Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05Living organisms or biological materials

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
AU2015222150A 2014-02-27 2015-02-26 Process for producing a stable low concentration, injectable solution of noradrenaline Active AU2015222150B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITMI20140306 2014-02-27
ITMI2014A000306 2014-02-27
PCT/EP2015/054021 WO2015128418A1 (en) 2014-02-27 2015-02-26 Process for producing a stable low concentration, injectable solution of noradrenaline

Publications (2)

Publication Number Publication Date
AU2015222150A1 AU2015222150A1 (en) 2016-10-13
AU2015222150B2 true AU2015222150B2 (en) 2019-12-05

Family

ID=50693780

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2015222150A Active AU2015222150B2 (en) 2014-02-27 2015-02-26 Process for producing a stable low concentration, injectable solution of noradrenaline

Country Status (43)

Country Link
US (4) USRE49422E1 (enExample)
EP (1) EP3110399B1 (enExample)
JP (1) JP6635927B2 (enExample)
KR (1) KR102306706B1 (enExample)
CN (1) CN106061467B (enExample)
AP (1) AP2016009467A0 (enExample)
AR (1) AR101148A1 (enExample)
AU (1) AU2015222150B2 (enExample)
BR (1) BR112016019804B1 (enExample)
CA (1) CA2940347C (enExample)
CL (1) CL2016002073A1 (enExample)
CR (1) CR20160420A (enExample)
CY (1) CY1120125T1 (enExample)
DK (1) DK3110399T3 (enExample)
DO (1) DOP2016000210A (enExample)
EA (1) EA031444B1 (enExample)
EC (1) ECSP16065957A (enExample)
ES (1) ES2663817T3 (enExample)
GE (1) GEP20186829B (enExample)
HR (1) HRP20180541T1 (enExample)
HU (1) HUE038738T2 (enExample)
IL (1) IL247501B (enExample)
JO (1) JO3552B1 (enExample)
LT (1) LT3110399T (enExample)
MA (1) MA39200A1 (enExample)
MD (1) MD4628C1 (enExample)
ME (1) ME03004B (enExample)
MX (1) MX367148B (enExample)
MY (1) MY179942A (enExample)
NI (1) NI201600118A (enExample)
PE (1) PE20161375A1 (enExample)
PH (1) PH12016501703B1 (enExample)
PL (1) PL3110399T3 (enExample)
PT (1) PT3110399T (enExample)
RS (1) RS57044B1 (enExample)
SG (1) SG11201607094WA (enExample)
SI (1) SI3110399T1 (enExample)
SM (1) SMT201800239T1 (enExample)
SV (1) SV2016005265A (enExample)
TW (1) TWI673065B (enExample)
UA (1) UA118043C2 (enExample)
UY (1) UY35988A (enExample)
WO (1) WO2015128418A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UY35988A (es) 2014-02-27 2015-09-30 Sint Sa Proceso para la producción de una solución inyectable de noradrenalina de baja concentración
PL2990031T3 (pl) 2014-08-28 2020-05-18 Sun Pharmaceutical Industries Ltd Pozajelitowa postać norepinefryny
CA3051467C (en) 2017-01-30 2022-11-29 Nevakar, Inc Norepinephrine compositions and methods therefor
US20250177328A1 (en) 2017-01-30 2025-06-05 Nevakar Injectables Inc. Norepinephrine compositions and methods therefor
CN109394683A (zh) * 2018-12-07 2019-03-01 远大医药(中国)有限公司 一种重酒石酸去甲肾上腺素注射液的制备方法
US10888534B2 (en) * 2019-04-26 2021-01-12 InfoRLife SA Storage stable ready-to-use norepinephrine aqueous solutions in flexible plastic bags
CA3174640A1 (en) * 2020-03-06 2021-09-10 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
PL4051251T3 (pl) * 2020-10-21 2024-04-08 Sintetica S.A. Stabilne, wolne od antyoksydantów roztwory noradrenaliny do wstrzykiwania
US20220117843A1 (en) * 2020-10-21 2022-04-21 Sintetica S.A. Ready to use, noradrenaline drip bags, having low subvisible particle counts
US11331266B1 (en) * 2020-10-29 2022-05-17 Medefil, Inc. Antioxidant free, norepinephrine bitartrate injection in amber glass vials
US20220233473A1 (en) * 2021-01-28 2022-07-28 Cumberland Pharmaceuticals Inc. Injectable solution of norepinephrine
AR124867A1 (es) 2021-02-15 2023-05-10 Sintetica S A Un medicamento en una bolsa de goteo intravenoso plegable lista para usar herméticamente sellada, método para hacer dicho medicamento y medicamento elaborado mediante dicho método
CN116327697A (zh) * 2023-04-17 2023-06-27 福安药业集团庆余堂制药有限公司 一种重酒石酸去甲肾上腺素注射液及其制剂工艺

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050070613A1 (en) * 2001-11-15 2005-03-31 Bernard Dinnequin Method for producing stable solutions of phenolic substances and resulting solutions

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FR2809619B1 (fr) * 2000-06-06 2004-09-24 Pharmatop Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention
BR0311965A (pt) 2002-06-20 2005-03-29 Novalar Pharmaceutical Inc Formulações estabilizadas de antagonistas de receptores alfa adrenérgicos e os seus usos
US20040005401A1 (en) 2002-07-05 2004-01-08 Robert Becker Method for applying a washcoat to suppport bodies
US7078876B2 (en) 2003-07-07 2006-07-18 Pentadyne Power Corporation Feedforward controller for synchronous reluctance machines
FR2880807B1 (fr) * 2005-01-19 2007-04-13 Aguettant Sa Lab Composition pharmaceutique injectable
US7465489B2 (en) 2005-11-15 2008-12-16 Poly-Med, Inc. Inorganic-organic melted-extruded hybrid filaments and medical applications thereof
FR2894154B1 (fr) 2005-12-06 2008-03-14 Pharmatop Scr Nouveau procede de stabilisation de substances minerales ou organiques sensibles a l'oxydation.
EP2096433A1 (de) 2008-02-26 2009-09-02 Siemens Aktiengesellschaft Vorrichtung zur zerstörungsfreien Materialprüfung eines Prüfgegenstands mit Ultraschallwellen
US8419689B2 (en) 2008-09-30 2013-04-16 Covidien Lp Enclosing package for medical port and cover
CN102802668A (zh) * 2009-06-04 2012-11-28 Alk股份公司 包含至少一种肾上腺素能化合物的稳定化组合物
US8628805B2 (en) 2009-06-04 2014-01-14 Alk Ag Stabilized composition comprising at least one adrenergic compound
FR2963237B1 (fr) 2010-07-28 2013-05-17 Aguettant Lab Nouvelle composition pharmaceutique utile pour prevenir ou traiter l'hypotension arterielle peroperatoire chez l'etre humain
CN102525895B (zh) 2012-01-04 2013-11-06 上海禾丰制药有限公司 重酒石酸去甲肾上腺素注射液及其制剂工艺
UY35988A (es) 2014-02-27 2015-09-30 Sint Sa Proceso para la producción de una solución inyectable de noradrenalina de baja concentración
US20160005871A1 (en) 2014-07-04 2016-01-07 Semiconductor Energy Laboratory Co., Ltd. Semiconductor device
CA3051467C (en) 2017-01-30 2022-11-29 Nevakar, Inc Norepinephrine compositions and methods therefor

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050070613A1 (en) * 2001-11-15 2005-03-31 Bernard Dinnequin Method for producing stable solutions of phenolic substances and resulting solutions

Also Published As

Publication number Publication date
US20170049720A1 (en) 2017-02-23
PL3110399T3 (pl) 2018-07-31
KR102306706B1 (ko) 2021-09-30
DOP2016000210A (es) 2016-11-30
AR101148A1 (es) 2016-11-30
USRE49443E1 (en) 2023-03-07
TWI673065B (zh) 2019-10-01
ECSP16065957A (es) 2017-01-31
MD4628B1 (ro) 2019-05-31
EP3110399A1 (en) 2017-01-04
MA39200A1 (fr) 2017-06-30
HUE038738T2 (hu) 2018-11-28
CL2016002073A1 (es) 2017-02-10
EA201691734A1 (ru) 2016-12-30
EA031444B1 (ru) 2019-01-31
USRE49555E1 (en) 2023-06-20
LT3110399T (lt) 2018-04-25
GEP20186829B (en) 2018-02-26
SMT201800239T1 (it) 2018-07-17
MY179942A (en) 2020-11-19
PH12016501703B1 (en) 2019-08-23
CN106061467B (zh) 2021-02-05
BR112016019804A2 (enExample) 2017-08-15
AU2015222150A1 (en) 2016-10-13
CA2940347C (en) 2021-04-27
ME03004B (me) 2018-10-20
MD4628C1 (ro) 2019-12-31
JP2017506632A (ja) 2017-03-09
AP2016009467A0 (en) 2016-09-30
CN106061467A (zh) 2016-10-26
CA2940347A1 (en) 2015-09-03
WO2015128418A1 (en) 2015-09-03
SV2016005265A (es) 2017-01-18
US10251848B2 (en) 2019-04-09
MX2016011148A (es) 2016-12-09
PH12016501703A1 (en) 2016-12-19
JO3552B1 (ar) 2020-07-05
MX367148B (es) 2019-08-07
KR20160122264A (ko) 2016-10-21
BR112016019804B1 (pt) 2022-03-03
EP3110399B1 (en) 2018-01-10
ES2663817T3 (es) 2018-04-17
SG11201607094WA (en) 2016-09-29
JP6635927B2 (ja) 2020-01-29
SI3110399T1 (en) 2018-05-31
HRP20180541T1 (hr) 2018-05-04
CR20160420A (es) 2016-12-14
RS57044B1 (sr) 2018-05-31
DK3110399T3 (en) 2018-04-09
MD20160103A2 (ro) 2017-01-31
UY35988A (es) 2015-09-30
TW201620499A (zh) 2016-06-16
UA118043C2 (uk) 2018-11-12
CY1120125T1 (el) 2018-12-12
PE20161375A1 (es) 2017-01-05
IL247501A0 (en) 2016-11-30
IL247501B (en) 2020-05-31
NI201600118A (es) 2016-10-03
USRE49422E1 (en) 2023-02-21
PT3110399T (pt) 2018-04-19

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