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 concentration

Info

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
Application number
MA39200A
Other languages
English (en)
Inventor
Augusto Mitidieri
Elisabetta Donati
Nicola Caronzolo
Original Assignee
Sintetica S A
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
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=MA39200(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sintetica S A filed Critical Sintetica S A
Publication of MA39200A1 publication Critical patent/MA39200A1/fr

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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (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

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.
MA39200A 2014-02-27 2015-02-26 Procédé de fabrication d'une solution injectable stable de noradrénaline à faible concentration MA39200A1 (fr)

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)

Country Link
US (4) US10251848B2 (fr)
EP (1) EP3110399B1 (fr)
JP (1) JP6635927B2 (fr)
KR (1) KR102306706B1 (fr)
CN (1) CN106061467B (fr)
AP (1) AP2016009467A0 (fr)
AR (1) AR101148A1 (fr)
AU (1) AU2015222150B2 (fr)
BR (1) BR112016019804B1 (fr)
CA (1) CA2940347C (fr)
CL (1) CL2016002073A1 (fr)
CR (1) CR20160420A (fr)
CY (1) CY1120125T1 (fr)
DK (1) DK3110399T3 (fr)
DO (1) DOP2016000210A (fr)
EA (1) EA031444B1 (fr)
EC (1) ECSP16065957A (fr)
ES (1) ES2663817T3 (fr)
GE (1) GEP20186829B (fr)
HR (1) HRP20180541T1 (fr)
HU (1) HUE038738T2 (fr)
IL (1) IL247501B (fr)
JO (1) JO3552B1 (fr)
LT (1) LT3110399T (fr)
MA (1) MA39200A1 (fr)
MD (1) MD4628C1 (fr)
ME (1) ME03004B (fr)
MX (1) MX367148B (fr)
MY (1) MY179942A (fr)
NI (1) NI201600118A (fr)
PE (1) PE20161375A1 (fr)
PH (1) PH12016501703B1 (fr)
PL (1) PL3110399T3 (fr)
PT (1) PT3110399T (fr)
RS (1) RS57044B1 (fr)
SG (1) SG11201607094WA (fr)
SI (1) SI3110399T1 (fr)
SM (1) SMT201800239T1 (fr)
SV (1) SV2016005265A (fr)
TW (1) TWI673065B (fr)
UA (1) UA118043C2 (fr)
UY (1) UY35988A (fr)
WO (1) WO2015128418A1 (fr)

Families Citing this family (12)

* 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
EP2990031B1 (fr) 2014-08-28 2019-11-13 Sun Pharmaceutical Industries Ltd Forme de dosage parentéral de la norépinéphrine
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
EP4114336A1 (fr) 2020-03-06 2023-01-11 Baxter International Inc. Système de récipient scellé conditionné de stockage stable de formulation pharmaceutique sensible à l'oxygène
CA3198908A1 (fr) 2020-10-21 2022-04-28 Sintetica S.A. Solutions de noradrenaline injectables stables exemptes d'antioxydants
EP4231996B1 (fr) 2020-10-21 2024-09-18 Sintetica S.A. Poches de perfusion prêtes à l'emploi, à faible nombre de particules subvisibles
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
US12564561B2 (en) 2021-02-15 2026-03-03 Sintetica S.A. Dilute ready to use large volume containers of phenylephrine

Family Cites Families (17)

* Cited by examiner, † Cited by third party
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
MXPA04012507A (es) 2002-06-20 2005-06-08 Novalar Pharmaceuticals Inc Formulaciones estabilizadas para antoagonistas del receptor alfa-adrenergico y usos de las mismas.
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
US8628805B2 (en) 2009-06-04 2014-01-14 Alk Ag Stabilized composition comprising at least one adrenergic compound
ES2432164T3 (es) * 2009-06-04 2013-12-02 Alk Ag Composición estabilizada que comprende al menos un compuesto adrenérgico
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

Also Published As

Publication number Publication date
BR112016019804A2 (fr) 2017-08-15
ES2663817T3 (es) 2018-04-17
DOP2016000210A (es) 2016-11-30
MD20160103A2 (ro) 2017-01-31
ECSP16065957A (es) 2017-01-31
IL247501A0 (en) 2016-11-30
JP6635927B2 (ja) 2020-01-29
UY35988A (es) 2015-09-30
BR112016019804B1 (pt) 2022-03-03
PT3110399T (pt) 2018-04-19
CN106061467B (zh) 2021-02-05
MD4628C1 (ro) 2019-12-31
USRE49443E1 (en) 2023-03-07
MX367148B (es) 2019-08-07
KR20160122264A (ko) 2016-10-21
PE20161375A1 (es) 2017-01-05
CR20160420A (es) 2016-12-14
LT3110399T (lt) 2018-04-25
USRE49422E1 (en) 2023-02-21
RS57044B1 (sr) 2018-05-31
US10251848B2 (en) 2019-04-09
WO2015128418A1 (fr) 2015-09-03
NI201600118A (es) 2016-10-03
AU2015222150B2 (en) 2019-12-05
AR101148A1 (es) 2016-11-30
SMT201800239T1 (it) 2018-07-17
US20170049720A1 (en) 2017-02-23
JP2017506632A (ja) 2017-03-09
AP2016009467A0 (en) 2016-09-30
TW201620499A (zh) 2016-06-16
MX2016011148A (es) 2016-12-09
ME03004B (fr) 2018-10-20
AU2015222150A1 (en) 2016-10-13
GEP20186829B (en) 2018-02-26
CY1120125T1 (el) 2018-12-12
CA2940347C (fr) 2021-04-27
CA2940347A1 (fr) 2015-09-03
MD4628B1 (ro) 2019-05-31
TWI673065B (zh) 2019-10-01
SI3110399T1 (en) 2018-05-31
JO3552B1 (ar) 2020-07-05
CL2016002073A1 (es) 2017-02-10
SV2016005265A (es) 2017-01-18
USRE49555E1 (en) 2023-06-20
CN106061467A (zh) 2016-10-26
HUE038738T2 (hu) 2018-11-28
EP3110399B1 (fr) 2018-01-10
KR102306706B1 (ko) 2021-09-30
EA031444B1 (ru) 2019-01-31
IL247501B (en) 2020-05-31
SG11201607094WA (en) 2016-09-29
PL3110399T3 (pl) 2018-07-31
MY179942A (en) 2020-11-19
DK3110399T3 (en) 2018-04-09
PH12016501703B1 (en) 2019-08-23
EP3110399A1 (fr) 2017-01-04
HRP20180541T1 (hr) 2018-05-04
PH12016501703A1 (en) 2016-12-19
UA118043C2 (uk) 2018-11-12
EA201691734A1 (ru) 2016-12-30

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