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CL2016002073A1 - Proceso para producir una solución inyectable de noradrenalina de baja concentración estable - Google Patents

Proceso para producir una solución inyectable de noradrenalina de baja concentración estable

Info

Publication number
CL2016002073A1
CL2016002073A1 CL2016002073A CL2016002073A CL2016002073A1 CL 2016002073 A1 CL2016002073 A1 CL 2016002073A1 CL 2016002073 A CL2016002073 A CL 2016002073A CL 2016002073 A CL2016002073 A CL 2016002073A CL 2016002073 A1 CL2016002073 A1 CL 2016002073A1
Authority
CL
Chile
Prior art keywords
norepinephrine
solution
produce
low concentration
injectable solution
Prior art date
Application number
CL2016002073A
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=CL2016002073(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 CL2016002073A1 publication Critical patent/CL2016002073A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • A61L2103/05
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/02Drugs for disorders of the nervous system for peripheral neuropathies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs 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

<p>En un primer aspecto, la presente invención se refiere a un proceso para producir una solución inyectable, estable con bajo contenido de noradrenalina, que incluye disolver noradrenalina y opcionalmente un excipiente en agua desoxigenada o desgasificada, filtrar la solución de noradrenalina resultante en una corriente de nitrógeno, distribuir la solución en una corriente de nitrógeno, y esterilización, preferiblemente caliente. La invención proporciona además una solución inyectable, estable con bajo cont</p>
CL2016002073A 2014-02-27 2016-08-17 Proceso para producir una solución inyectable de noradrenalina de baja concentración estable CL2016002073A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ITMI20140306 2014-02-27

Publications (1)

Publication Number Publication Date
CL2016002073A1 true CL2016002073A1 (es) 2017-02-10

Family

ID=50693780

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2016002073A CL2016002073A1 (es) 2014-02-27 2016-08-17 Proceso para producir una solución inyectable de noradrenalina de baja concentración estable

Country Status (43)

Country Link
US (4) USRE49555E1 (es)
EP (1) EP3110399B1 (es)
JP (1) JP6635927B2 (es)
KR (1) KR102306706B1 (es)
CN (1) CN106061467B (es)
AP (1) AP2016009467A0 (es)
AR (1) AR101148A1 (es)
AU (1) AU2015222150B2 (es)
BR (1) BR112016019804B1 (es)
CA (1) CA2940347C (es)
CL (1) CL2016002073A1 (es)
CR (1) CR20160420A (es)
CY (1) CY1120125T1 (es)
DK (1) DK3110399T3 (es)
DO (1) DOP2016000210A (es)
EA (1) EA031444B1 (es)
EC (1) ECSP16065957A (es)
ES (1) ES2663817T3 (es)
GE (1) GEP20186829B (es)
HR (1) HRP20180541T1 (es)
HU (1) HUE038738T2 (es)
IL (1) IL247501B (es)
JO (1) JO3552B1 (es)
LT (1) LT3110399T (es)
MA (1) MA39200A1 (es)
MD (1) MD4628C1 (es)
ME (1) ME03004B (es)
MX (1) MX367148B (es)
MY (1) MY179942A (es)
NI (1) NI201600118A (es)
PE (1) PE20161375A1 (es)
PH (1) PH12016501703B1 (es)
PL (1) PL3110399T3 (es)
PT (1) PT3110399T (es)
RS (1) RS57044B1 (es)
SG (1) SG11201607094WA (es)
SI (1) SI3110399T1 (es)
SM (1) SMT201800239T1 (es)
SV (1) SV2016005265A (es)
TW (1) TWI673065B (es)
UA (1) UA118043C2 (es)
UY (1) UY35988A (es)
WO (1) WO2015128418A1 (es)

Families Citing this family (13)

* 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
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 (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
WO2021178946A1 (en) 2020-03-06 2021-09-10 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
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)

* Cited by examiner, † Cited by third party
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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 (en) 2002-06-20 2012-03-20 Novalar Pharmaceuticals, Inc. Stabilized formulations of alpha adrenergic receptor antagonists and uses thereof
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
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 (en) 2017-01-30 2018-08-02 Nevakar, Inc Norepinephrine compositions and methods therefor

Also Published As

Publication number Publication date
CY1120125T1 (el) 2018-12-12
EA201691734A1 (ru) 2016-12-30
DOP2016000210A (es) 2016-11-30
EP3110399B1 (en) 2018-01-10
CN106061467B (zh) 2021-02-05
MX2016011148A (es) 2016-12-09
ES2663817T3 (es) 2018-04-17
USRE49443E1 (en) 2023-03-07
KR102306706B1 (ko) 2021-09-30
CA2940347A1 (en) 2015-09-03
MY179942A (en) 2020-11-19
UY35988A (es) 2015-09-30
WO2015128418A1 (en) 2015-09-03
GEP20186829B (en) 2018-02-26
ECSP16065957A (es) 2017-01-31
BR112016019804B1 (pt) 2022-03-03
HRP20180541T1 (hr) 2018-05-04
JP6635927B2 (ja) 2020-01-29
MX367148B (es) 2019-08-07
USRE49422E1 (en) 2023-02-21
AU2015222150B2 (en) 2019-12-05
PT3110399T (pt) 2018-04-19
EA031444B1 (ru) 2019-01-31
ME03004B (me) 2018-10-20
CA2940347C (en) 2021-04-27
NI201600118A (es) 2016-10-03
KR20160122264A (ko) 2016-10-21
SMT201800239T1 (it) 2018-07-17
US20170049720A1 (en) 2017-02-23
US10251848B2 (en) 2019-04-09
SV2016005265A (es) 2017-01-18
HUE038738T2 (hu) 2018-11-28
IL247501A0 (en) 2016-11-30
PL3110399T3 (pl) 2018-07-31
EP3110399A1 (en) 2017-01-04
LT3110399T (lt) 2018-04-25
TWI673065B (zh) 2019-10-01
IL247501B (en) 2020-05-31
UA118043C2 (uk) 2018-11-12
SI3110399T1 (en) 2018-05-31
RS57044B1 (sr) 2018-05-31
SG11201607094WA (en) 2016-09-29
TW201620499A (zh) 2016-06-16
DK3110399T3 (en) 2018-04-09
PE20161375A1 (es) 2017-01-05
CR20160420A (es) 2016-12-14
AU2015222150A1 (en) 2016-10-13
MD4628C1 (ro) 2019-12-31
JP2017506632A (ja) 2017-03-09
PH12016501703A1 (en) 2016-12-19
JO3552B1 (ar) 2020-07-05
MD4628B1 (ro) 2019-05-31
USRE49555E1 (en) 2023-06-20
BR112016019804A2 (es) 2017-08-15
AR101148A1 (es) 2016-11-30
MA39200A1 (fr) 2017-06-30
AP2016009467A0 (en) 2016-09-30
CN106061467A (zh) 2016-10-26
PH12016501703B1 (en) 2019-08-23
MD20160103A2 (ro) 2017-01-31

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