MA39200A1 - Procédé de fabrication d'une solution injectable stable de noradrénaline à faible concentration - Google Patents
Procédé de fabrication d'une solution injectable stable de noradrénaline à faible concentrationInfo
- Publication number
- MA39200A1 MA39200A1 MA39200A MA39200A MA39200A1 MA 39200 A1 MA39200 A1 MA 39200A1 MA 39200 A MA39200 A MA 39200A MA 39200 A MA39200 A MA 39200A MA 39200 A1 MA39200 A1 MA 39200A1
- Authority
- MA
- Morocco
- Prior art keywords
- noradrenaline
- producing
- solution
- injectable solution
- stable low
- 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—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
-
- A61L2103/05—
-
- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Cardiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Molecular Biology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Dans un premier aspect, la présente invention concerne un procédé de production d'une solution injectable, stable à faible teneur en noradrénaline, qui comprend la dissolution de la noradrénaline et facultativement d'un excipient dans de l'eau désoxygénée ou dégazée, la filtration de la solution résultante de noradrénaline dans un courant d'azote, la répartition de la solution dans un courant d'azote, et la stérilisation, de préférence à chaud. L'invention concerne en outre une solution injectable, stable à faible teneur en noradrénaline, sensiblement exempte d'anti-oxydant et d'agents de conservation, ainsi que ses utilisations dans les domaines médical et pharmaceutique.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITMI20140306 | 2014-02-27 | ||
| PCT/EP2015/054021 WO2015128418A1 (fr) | 2014-02-27 | 2015-02-26 | Procédé de fabrication d'une solution injectable stable de noradrénaline à faible concentration |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MA39200A1 true MA39200A1 (fr) | 2017-06-30 |
Family
ID=50693780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MA39200A MA39200A1 (fr) | 2014-02-27 | 2015-02-26 | Procédé de fabrication d'une solution injectable stable de noradrénaline à faible concentration |
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 |
| US20250177328A1 (en) | 2017-01-30 | 2025-06-05 | Nevakar Injectables Inc. | Norepinephrine compositions and methods therefor |
| WO2018140894A1 (fr) | 2017-01-30 | 2018-08-02 | Nevakar, Inc | Compositions de norépinéphrine et procédés associés |
| 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 |
| WO2021178946A1 (fr) | 2020-03-06 | 2021-09-10 | Baxter International Inc. | Système de récipient scellé conditionné de stockage stable de formulation pharmaceutique sensible à l'oxygène |
| IL301878A (en) * | 2020-10-21 | 2023-06-01 | Sintetica S A | NORADRENALINE drip bags are ready to use, with a low sub-visible particle count |
| AU2021366122B2 (en) * | 2020-10-21 | 2025-03-06 | Sintetica S.A. | Stable, injectable noradrenaline solutions free of antioxidants |
| 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 |
| 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 |
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 |
| CA2489526C (fr) | 2002-06-20 | 2012-03-20 | Novalar Pharmaceuticals, Inc. | Formulations stabilisees d'antagonistes de recepteurs adrenergiques alpha et leur utilisation |
| 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 (fr) | 2008-02-26 | 2009-09-02 | Siemens Aktiengesellschaft | Dispositif de contrôle non destructif de matériau d'un objet de test à l'aide d'ondes à ultrasons |
| US8419689B2 (en) | 2008-09-30 | 2013-04-16 | Covidien Lp | Enclosing package for medical port and cover |
| CN106109397A (zh) | 2009-06-04 | 2016-11-16 | 爱尔开-阿贝优公司 | 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 (fr) | 2017-01-30 | 2018-08-02 | Nevakar, Inc | Compositions de norépinéphrine et procédés associés |
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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 US US17/006,841 patent/USRE49555E1/en active Active
- 2015-02-26 WO PCT/EP2015/054021 patent/WO2015128418A1/fr not_active Ceased
- 2015-02-26 DK DK15712064.3T patent/DK3110399T3/en active
- 2015-02-26 AU AU2015222150A patent/AU2015222150B2/en active Active
- 2015-02-26 AP AP2016009467A patent/AP2016009467A0/en unknown
- 2015-02-26 ES ES15712064.3T patent/ES2663817T3/es active Active
- 2015-02-26 KR KR1020167026245A patent/KR102306706B1/ko active Active
- 2015-02-26 BR BR112016019804-2A patent/BR112016019804B1/pt active IP Right Grant
- 2015-02-26 EP EP15712064.3A patent/EP3110399B1/fr active Active
- 2015-02-26 EA EA201691734A patent/EA031444B1/ru unknown
- 2015-02-26 UA UAA201609379A patent/UA118043C2/uk unknown
- 2015-02-26 CN CN201580010039.4A patent/CN106061467B/zh active Active
- 2015-02-26 US US17/006,840 patent/USRE49422E1/en active Active
- 2015-02-26 US US15/118,864 patent/US10251848B2/en not_active Ceased
- 2015-02-26 LT LTEP15712064.3T patent/LT3110399T/lt unknown
- 2015-02-26 HR HRP20180541TT patent/HRP20180541T1/hr unknown
- 2015-02-26 PL PL15712064T patent/PL3110399T3/pl unknown
- 2015-02-26 CR CR20160420A patent/CR20160420A/es unknown
- 2015-02-26 MX MX2016011148A patent/MX367148B/es active IP Right Grant
- 2015-02-26 RS RS20180352A patent/RS57044B1/sr unknown
- 2015-02-26 ME MEP-2018-88A patent/ME03004B/fr unknown
- 2015-02-26 PE PE2016001537A patent/PE20161375A1/es unknown
- 2015-02-26 MA MA39200A patent/MA39200A1/fr unknown
- 2015-02-26 SG SG11201607094WA patent/SG11201607094WA/en unknown
- 2015-02-26 SM SM20180239T patent/SMT201800239T1/it unknown
- 2015-02-26 SI SI201530205T patent/SI3110399T1/en unknown
- 2015-02-26 JP JP2016551222A patent/JP6635927B2/ja active Active
- 2015-02-26 GE GEAP201714278A patent/GEP20186829B/en unknown
- 2015-02-26 PT PT157120643T patent/PT3110399T/pt unknown
- 2015-02-26 MD MDA20160103A patent/MD4628C1/ro not_active IP Right Cessation
- 2015-02-26 CA CA2940347A patent/CA2940347C/fr active Active
- 2015-02-26 HU HUE15712064A patent/HUE038738T2/hu unknown
- 2015-02-26 US US17/006,838 patent/USRE49443E1/en active Active
- 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
- 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
-
2018
- 2018-04-05 CY CY20181100385T patent/CY1120125T1/el unknown
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