ES2663817T3 - Proceso para producir una disolución inyectable estable de noradrenalina a baja concentración - Google Patents
Proceso para producir una disolución inyectable estable de noradrenalina a baja concentración Download PDFInfo
- Publication number
- ES2663817T3 ES2663817T3 ES15712064.3T ES15712064T ES2663817T3 ES 2663817 T3 ES2663817 T3 ES 2663817T3 ES 15712064 T ES15712064 T ES 15712064T ES 2663817 T3 ES2663817 T3 ES 2663817T3
- Authority
- ES
- Spain
- Prior art keywords
- norepinephrine
- solution
- noradrenaline
- produce
- injectable solution
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
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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
Landscapes
- 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)
Abstract
Un proceso para producir una disolución inyectable estable que contiene noradrenalina de 0,04 a 0,20 mg/ml, que se caracteriza porque incluye las siguientes etapas: a. disolver la noradrenalina y opcionalmente un excipiente en agua desoxigenada o desgasificada para obtener una concentración de noradrenalina de 0,04 a 0,20 mg/ml, b. ajustar el pH de la disolución resultante añadiendo ácido clorhídrico hasta alcanzar un valor en el intervalo de 3,2 a 3,6, c. filtrar la disolución de noradrenalina resultante en una corriente de gas inerte, d. distribuir la disolución de noradrenalina en una corriente de un gas inerte, e. esterilizar la disolución de noradrenalina.
Description
Claims (1)
-
imagen1
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI20140306 | 2014-02-27 | ||
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 |
---|---|
ES2663817T3 true ES2663817T3 (es) | 2018-04-17 |
Family
ID=50693780
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES15712064.3T Active ES2663817T3 (es) | 2014-02-27 | 2015-02-26 | Proceso para producir una disolución inyectable estable de noradrenalina a baja concentración |
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 |
ES2770731T3 (es) | 2014-08-28 | 2020-07-02 | Sun Pharmaceutical Ind Ltd | Forma de dosificación parenteral de norepinefrina |
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 |
CA3174640A1 (en) * | 2020-03-06 | 2021-09-10 | Baxter International Inc. | Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation |
CA3198908A1 (en) * | 2020-10-21 | 2022-04-28 | Sintetica S.A. | Stable, injectable noradrenaline solutions free of antioxidants |
WO2022084775A1 (en) * | 2020-10-21 | 2022-04-28 | 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 |
US20220257537A1 (en) | 2021-02-15 | 2022-08-18 | Sintetica S.A. | Dilute ready to use large volume containers of phenylephrine |
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 |
US8628805B2 (en) | 2009-06-04 | 2014-01-14 | Alk Ag | Stabilized composition comprising at least one adrenergic compound |
SI2437782T1 (sl) * | 2009-06-04 | 2013-12-31 | Alk Ag | Stabiliziran sestavek, ki obsega vsaj eno adrenergično spojino |
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 DK DK15712064.3T patent/DK3110399T3/en active
- 2015-02-26 US US17/006,838 patent/USRE49443E1/en active Active
- 2015-02-26 PL PL15712064T patent/PL3110399T3/pl unknown
- 2015-02-26 SI SI201530205T patent/SI3110399T1/en unknown
- 2015-02-26 US US17/006,841 patent/USRE49555E1/en active Active
- 2015-02-26 ES ES15712064.3T patent/ES2663817T3/es active Active
- 2015-02-26 PT PT157120643T patent/PT3110399T/pt unknown
- 2015-02-26 UA UAA201609379A patent/UA118043C2/uk unknown
- 2015-02-26 WO PCT/EP2015/054021 patent/WO2015128418A1/en active Application Filing
- 2015-02-26 JP JP2016551222A patent/JP6635927B2/ja active Active
- 2015-02-26 LT LTEP15712064.3T patent/LT3110399T/lt unknown
- 2015-02-26 AU AU2015222150A patent/AU2015222150B2/en active Active
- 2015-02-26 SG SG11201607094WA patent/SG11201607094WA/en unknown
- 2015-02-26 US US17/006,840 patent/USRE49422E1/en active Active
- 2015-02-26 MY MYPI2016703113A patent/MY179942A/en unknown
- 2015-02-26 KR KR1020167026245A patent/KR102306706B1/ko active IP Right Grant
- 2015-02-26 MD MDA20160103A patent/MD4628C1/ro not_active IP Right Cessation
- 2015-02-26 PE PE2016001537A patent/PE20161375A1/es 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 CR CR20160420A patent/CR20160420A/es unknown
- 2015-02-26 RS RS20180352A patent/RS57044B1/sr unknown
- 2015-02-26 CN CN201580010039.4A patent/CN106061467B/zh active Active
- 2015-02-26 MA MA39200A patent/MA39200A1/fr unknown
- 2015-02-26 HU HUE15712064A patent/HUE038738T2/hu unknown
- 2015-02-26 US US15/118,864 patent/US10251848B2/en not_active Ceased
- 2015-02-26 EA EA201691734A patent/EA031444B1/ru unknown
- 2015-02-26 AP AP2016009467A patent/AP2016009467A0/en unknown
- 2015-02-26 CA CA2940347A patent/CA2940347C/en active Active
- 2015-02-26 ME MEP-2018-88A patent/ME03004B/me unknown
- 2015-02-26 MX MX2016011148A patent/MX367148B/es active IP Right Grant
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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 SV SV2016005265A patent/SV2016005265A/es unknown
- 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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