DK3110399T3 - Fremgangsmåde til fremstilling af en stabil injicerbar opløsning af noradrenalin med lav koncentration - Google Patents
Fremgangsmåde til fremstilling af en stabil injicerbar opløsning af noradrenalin med lav koncentration Download PDFInfo
- Publication number
- DK3110399T3 DK3110399T3 DK15712064.3T DK15712064T DK3110399T3 DK 3110399 T3 DK3110399 T3 DK 3110399T3 DK 15712064 T DK15712064 T DK 15712064T DK 3110399 T3 DK3110399 T3 DK 3110399T3
- Authority
- DK
- Denmark
- Prior art keywords
- noradrenaline
- solution
- stable injectable
- injectable
- stable
- Prior art date
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Classifications
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- 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0023—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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Neurology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (16)
1. Fremgangsmåde til fremstilling af en stabil injicerbar opløsning indeholdende fra 0,04 til 0,20 mg/ml noradrenalin, kendetegnet ved at indbefatte følgende trin: a. at opløse noradrenalin og eventuelt en excipiens i deoxygeneret eller af-gasset vand, til opnåelse af en koncentration af noradrenalin fra 0,04 til 0,20 mg/ml, b. at justere pH-værdien af den resulterende opløsning ved at tilsætte saltsyre, indtil der opnås en værdi i området fra 3,2 til 3,6, c. at filtrere den resulterende noradrenalin-opløsning i en inert gasstrøm, d. at fordele noradrenalin-opløsningen i en inert gasstrøm, e. at sterilisere noradrenalin-opløsningen.
2. Fremgangsmåde ifølge krav 1, hvor det deoxygenerede eller afgassede vand opnås ved at blæse eller boble en inert gasstrøm.
3. Fremgangsmåde ifølge krav 2, hvor vandet, der er deoxygeneret ved blæsning eller bobling af en inert gasstrøm, har et oxygenindhold under 100 ppb.
4. Fremgangsmåde ifølge et hvilket som af kravene 1-3, hvor den inerte gas er udvalgt blandt nitrogen, argon eller en blanding deraf.
5. Fremgangsmåde ifølge et hvilket som af kravene 1-4, hvor pH-værdien i trin b er i området 3,3 til 3,6.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1-5, hvor excipien-sen, der opløses i trin a), er natriumchlorid.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1-6, hvor trin a) omfatter omrøring af noradrenalin-opløsningen i en nitrogenstrøm.
8. Fremgangsmåde ifølge et hvilket som helst af kravene 1-7, hvor steriliseringstrin e) udføres under opvarmning.
9. Stabil injicerbar noradrenalin-opløsning med en mængde af konserveringsmidler og/eller antioxiderende midler, der er lavere end 0,005 vægt-%, hvor opløsningsmidlet er afgassset eller afluftet vand, koncentrationen af noradrenalin ligger i området fra 0,04 til 0,2 mg/ml, og pH-værdien er fra 3,2 til 3,6 ved hjælp af saltsyre.
10. Stabil injicerbar noradrenalin-opløsning ifølge krav 9, hvor pH-værdien er i området 3,3 til 3,6.
11. Stabil injicerbar noradrenalin-opløsning ifølge krav 9 eller 10, opnået ved en fremgangsmåde ifølge et hvilket som helst af kravene 1-8.
12. Stabil injicerbar noradrenalin-opløsning ifølge et hvilket som helst af kravene 9-11, yderligere omfattende en excipiens.
13. Stabil injicerbar noradrenalin-opløsning ifølge krav 12, hvor excipienen er natriumchlorid.
14. Stabil injicerbar noradrenalin-opløsning ifølge et hvilket som helst af kravene 9-13, med et oxygenindhold, der er lig med eller lavere end 100 ppb.
15. Stabil injicerbar noradrenalin-opløsning ifølge et hvilket som helst af kravene 9-13, som er uden antioxiderende midler og/eller konserveringsmidler.
16. Stabil injicerbar noradrenalin-opløsning ifølge et hvilket som helst af kravene 9-15, til anvendelse ved behandling af hjertekredsløbskollaps, ved shocktilstande forbundet med lav perifer resistens eller til genoprettelse og/eller opretholdelse af fysiologiske trykniveauer.
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 (1)
| Publication Number | Publication Date |
|---|---|
| DK3110399T3 true DK3110399T3 (da) | 2018-04-09 |
Family
ID=50693780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15712064.3T DK3110399T3 (da) | 2014-02-27 | 2015-02-26 | Fremgangsmåde til fremstilling af en stabil injicerbar opløsning af noradrenalin med lav koncentration |
Country Status (41)
Families Citing this family (11)
| 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 |
| EP2990031B1 (en) | 2014-08-28 | 2019-11-13 | Sun Pharmaceutical Industries Ltd | Parenteral dosage form of norepinephrine |
| WO2018140894A1 (en) | 2017-01-30 | 2018-08-02 | Nevakar, 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 |
| US12097170B2 (en) | 2020-03-06 | 2024-09-24 | Baxter International Inc. | Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation |
| WO2022084775A1 (en) * | 2020-10-21 | 2022-04-28 | Sintetica S.A. | Ready to use, noradrenaline drip bags, having low subvisible particle counts |
| PL4051251T3 (pl) * | 2020-10-21 | 2024-04-08 | Sintetica S.A. | Stabilne, wolne od antyoksydantów roztwory noradrenaliny do wstrzykiwania |
| 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 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2809619B1 (fr) | 2000-06-06 | 2004-09-24 | Pharmatop | Nouvelles formulations aqueuses de principes actifs sensibles a l'oxydation et leur procede d'obtention |
| FR2832063B1 (fr) * | 2001-11-15 | 2004-08-27 | Aguettant Lab | Procede de production de solutions stables de substances phenoliques et les solutions en resultant |
| 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 |
| CN102497882A (zh) * | 2009-06-04 | 2012-06-13 | 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 |
| WO2018140894A1 (en) | 2017-01-30 | 2018-08-02 | Nevakar, Inc | Norepinephrine compositions and methods therefor |
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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 ME MEP-2018-88A patent/ME03004B/me unknown
- 2015-02-26 US US17/006,841 patent/USRE49555E1/en active Active
- 2015-02-26 MA MA39200A patent/MA39200A1/fr unknown
- 2015-02-26 KR KR1020167026245A patent/KR102306706B1/ko active IP Right Grant
- 2015-02-26 BR BR112016019804-2A patent/BR112016019804B1/pt active IP Right Grant
- 2015-02-26 MD MDA20160103A patent/MD4628C1/ro not_active IP Right Cessation
- 2015-02-26 DK DK15712064.3T patent/DK3110399T3/da active
- 2015-02-26 ES ES15712064.3T patent/ES2663817T3/es active Active
- 2015-02-26 US US15/118,864 patent/US10251848B2/en not_active Ceased
- 2015-02-26 SI SI201530205T patent/SI3110399T1/en unknown
- 2015-02-26 US US17/006,838 patent/USRE49443E1/en active Active
- 2015-02-26 RS RS20180352A patent/RS57044B1/sr unknown
- 2015-02-26 CA CA2940347A patent/CA2940347C/en active Active
- 2015-02-26 LT LTEP15712064.3T patent/LT3110399T/lt unknown
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- 2015-02-26 AU AU2015222150A patent/AU2015222150B2/en active Active
- 2015-02-26 JP JP2016551222A patent/JP6635927B2/ja active Active
- 2015-02-26 UA UAA201609379A patent/UA118043C2/uk unknown
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- 2015-02-26 CN CN201580010039.4A patent/CN106061467B/zh active Active
- 2015-02-26 PE PE2016001537A patent/PE20161375A1/es unknown
- 2015-02-26 US US17/006,840 patent/USRE49422E1/en active Active
- 2015-02-26 EP EP15712064.3A patent/EP3110399B1/en active Active
- 2015-02-26 PT PT157120643T patent/PT3110399T/pt unknown
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- 2015-02-26 MX MX2016011148A patent/MX367148B/es active IP Right Grant
- 2015-02-26 HU HUE15712064A patent/HUE038738T2/hu unknown
- 2015-02-26 EA EA201691734A patent/EA031444B1/ru unknown
- 2015-02-26 WO PCT/EP2015/054021 patent/WO2015128418A1/en active Application Filing
- 2015-02-26 MY MYPI2016703113A patent/MY179942A/en unknown
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2016
- 2016-08-08 EC ECIEPI201665957A patent/ECSP16065957A/es unknown
- 2016-08-12 DO DO2016000210A patent/DOP2016000210A/es unknown
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- 2016-08-26 PH PH12016501703A patent/PH12016501703B1/en unknown
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2018
- 2018-04-04 HR HRP20180541TT patent/HRP20180541T1/hr unknown
- 2018-04-05 CY CY20181100385T patent/CY1120125T1/el unknown
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