EA031444B1 - Способ получения стабильного раствора для инъекций с низкой концентрацией норадреналина - Google Patents
Способ получения стабильного раствора для инъекций с низкой концентрацией норадреналина Download PDFInfo
- Publication number
- EA031444B1 EA031444B1 EA201691734A EA201691734A EA031444B1 EA 031444 B1 EA031444 B1 EA 031444B1 EA 201691734 A EA201691734 A EA 201691734A EA 201691734 A EA201691734 A EA 201691734A EA 031444 B1 EA031444 B1 EA 031444B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- norepinephrine
- solution
- injection
- inert gas
- stable solution
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
- A61L2/04—Heat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L2103/00—Materials or objects being the target of disinfection or sterilisation
- A61L2103/05—Living organisms or biological materials
Landscapes
- 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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITMI20140306 | 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 |
|---|---|
| EA201691734A1 EA201691734A1 (ru) | 2016-12-30 |
| EA031444B1 true EA031444B1 (ru) | 2019-01-31 |
Family
ID=50693780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201691734A EA031444B1 (ru) | 2014-02-27 | 2015-02-26 | Способ получения стабильного раствора для инъекций с низкой концентрацией норадреналина |
Country Status (43)
Families Citing this family (13)
| 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 (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040054012A1 (en) * | 2000-06-06 | 2004-03-18 | Francois Dietlin | Method for obtaining aqueous formulations of oxidation-sensitive active principles |
| US20050070613A1 (en) * | 2001-11-15 | 2005-03-31 | Bernard Dinnequin | Method for producing stable solutions of phenolic substances and resulting solutions |
| FR2880807A1 (fr) * | 2005-01-19 | 2006-07-21 | Aguettant Sa Lab | Composition pharmaceutique injectable |
Family Cites Families (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
-
2015
- 2015-02-10 UY UY0001035988A patent/UY35988A/es unknown
- 2015-02-12 JO JOP/2015/0031A patent/JO3552B1/ar active
- 2015-02-13 AR ARP150100456A patent/AR101148A1/es not_active Application Discontinuation
- 2015-02-24 TW TW104105762A patent/TWI673065B/zh not_active IP Right Cessation
- 2015-02-26 SG SG11201607094WA patent/SG11201607094WA/en unknown
- 2015-02-26 US US17/006,840 patent/USRE49422E1/en active Active
- 2015-02-26 EA EA201691734A patent/EA031444B1/ru unknown
- 2015-02-26 CR CR20160420A patent/CR20160420A/es unknown
- 2015-02-26 MD MDA20160103A patent/MD4628C1/ro not_active IP Right Cessation
- 2015-02-26 DK DK15712064.3T patent/DK3110399T3/en active
- 2015-02-26 SI SI201530205T patent/SI3110399T1/en unknown
- 2015-02-26 WO PCT/EP2015/054021 patent/WO2015128418A1/en not_active Ceased
- 2015-02-26 AU AU2015222150A patent/AU2015222150B2/en active Active
- 2015-02-26 HR HRP20180541TT patent/HRP20180541T1/hr unknown
- 2015-02-26 KR KR1020167026245A patent/KR102306706B1/ko active Active
- 2015-02-26 MY MYPI2016703113A patent/MY179942A/en unknown
- 2015-02-26 PT PT157120643T patent/PT3110399T/pt unknown
- 2015-02-26 HU HUE15712064A patent/HUE038738T2/hu unknown
- 2015-02-26 MA MA39200A patent/MA39200A1/fr unknown
- 2015-02-26 US US17/006,838 patent/USRE49443E1/en active Active
- 2015-02-26 PL PL15712064T patent/PL3110399T3/pl unknown
- 2015-02-26 ES ES15712064.3T patent/ES2663817T3/es active Active
- 2015-02-26 US US17/006,841 patent/USRE49555E1/en active Active
- 2015-02-26 PE PE2016001537A patent/PE20161375A1/es unknown
- 2015-02-26 CN CN201580010039.4A patent/CN106061467B/zh active Active
- 2015-02-26 JP JP2016551222A patent/JP6635927B2/ja active Active
- 2015-02-26 CA CA2940347A patent/CA2940347C/en active Active
- 2015-02-26 GE GEAP201714278A patent/GEP20186829B/en unknown
- 2015-02-26 MX MX2016011148A patent/MX367148B/es active IP Right Grant
- 2015-02-26 LT LTEP15712064.3T patent/LT3110399T/lt unknown
- 2015-02-26 US US15/118,864 patent/US10251848B2/en not_active Ceased
- 2015-02-26 RS RS20180352A patent/RS57044B1/sr unknown
- 2015-02-26 BR BR112016019804-2A patent/BR112016019804B1/pt active IP Right Grant
- 2015-02-26 EP EP15712064.3A patent/EP3110399B1/en active Active
- 2015-02-26 AP AP2016009467A patent/AP2016009467A0/en unknown
- 2015-02-26 ME MEP-2018-88A patent/ME03004B/me unknown
- 2015-02-26 UA UAA201609379A patent/UA118043C2/uk unknown
- 2015-02-26 SM SM20180239T patent/SMT201800239T1/it unknown
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2016
- 2016-08-08 EC ECIEPI201665957A patent/ECSP16065957A/es unknown
- 2016-08-12 DO DO2016000210A patent/DOP2016000210A/es unknown
- 2016-08-17 CL CL2016002073A patent/CL2016002073A1/es unknown
- 2016-08-18 NI NI201600118A patent/NI201600118A/es unknown
- 2016-08-25 IL IL247501A patent/IL247501B/en active IP Right Grant
- 2016-08-26 PH PH12016501703A patent/PH12016501703B1/en unknown
- 2016-08-26 SV SV2016005265A patent/SV2016005265A/es unknown
-
2018
- 2018-04-05 CY CY20181100385T patent/CY1120125T1/el unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040054012A1 (en) * | 2000-06-06 | 2004-03-18 | Francois Dietlin | Method for obtaining aqueous formulations of oxidation-sensitive active principles |
| US20050070613A1 (en) * | 2001-11-15 | 2005-03-31 | Bernard Dinnequin | Method for producing stable solutions of phenolic substances and resulting solutions |
| FR2880807A1 (fr) * | 2005-01-19 | 2006-07-21 | Aguettant Sa Lab | Composition pharmaceutique injectable |
Non-Patent Citations (1)
| Title |
|---|
| PARRY, T.J. ; CARTER, T.L. ; MCELLIGOTT, J.G.: "Physical and chemical considerations in the in vitro calibration of microdialysis probes for biogenic amine neurotransmitters and metabolites", JOURNAL OF NEUROSCIENCE METHODS., ELSEVIER SCIENCE PUBLISHER B.V., AMSTERDAM., NL, vol. 32, no. 3, 1 June 1990 (1990-06-01), NL, pages 175 - 183, XP024531687, ISSN: 0165-0270, DOI: 10.1016/0165-0270(90)90138-6 * |
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