PL2990031T3 - Pozajelitowa postać norepinefryny - Google Patents

Pozajelitowa postać norepinefryny

Info

Publication number
PL2990031T3
PL2990031T3 PL15182596T PL15182596T PL2990031T3 PL 2990031 T3 PL2990031 T3 PL 2990031T3 PL 15182596 T PL15182596 T PL 15182596T PL 15182596 T PL15182596 T PL 15182596T PL 2990031 T3 PL2990031 T3 PL 2990031T3
Authority
PL
Poland
Prior art keywords
norepinephrine
dosage form
parenteral dosage
parenteral
dosage
Prior art date
Application number
PL15182596T
Other languages
English (en)
Inventor
Rakesh Thummar
Shantaram Pawar
Prashant Kane
Samarth Kumar
Milan Natvarbhai Thakkar
Kandarp Maheshkumar Dave
Subhas Balaram Bhowmick
Original Assignee
Sun Pharmaceutical Industries Ltd
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
Application filed by Sun Pharmaceutical Industries Ltd filed Critical Sun Pharmaceutical Industries Ltd
Publication of PL2990031T3 publication Critical patent/PL2990031T3/pl

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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • 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
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
PL15182596T 2014-08-28 2015-08-26 Pozajelitowa postać norepinefryny PL2990031T3 (pl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2759MU2014 2014-08-28
EP15182596.5A EP2990031B1 (en) 2014-08-28 2015-08-26 Parenteral dosage form of norepinephrine

Publications (1)

Publication Number Publication Date
PL2990031T3 true PL2990031T3 (pl) 2020-05-18

Family

ID=55401249

Family Applications (1)

Application Number Title Priority Date Filing Date
PL15182596T PL2990031T3 (pl) 2014-08-28 2015-08-26 Pozajelitowa postać norepinefryny

Country Status (5)

Country Link
US (2) US9877935B2 (pl)
EP (1) EP2990031B1 (pl)
JP (1) JP6812094B2 (pl)
ES (1) ES2770731T3 (pl)
PL (1) PL2990031T3 (pl)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190350881A1 (en) 2016-06-17 2019-11-21 Ys Pharmtech Stabilization of epinephrine formulations
US10835503B2 (en) * 2017-01-13 2020-11-17 Teva Pharmaceuticals Usa, Inc. Pre-filled syringe
US20250177328A1 (en) 2017-01-30 2025-06-05 Nevakar Injectables Inc. Norepinephrine compositions and methods therefor
CA3051467C (en) 2017-01-30 2022-11-29 Nevakar, Inc Norepinephrine compositions and methods therefor
US10653646B2 (en) 2018-03-23 2020-05-19 Nevakar Inc. Epinephrine compositions and containers
PT3659594T (pt) * 2018-11-30 2020-12-28 Stegemann Klaus Uma solução estéril com uma seringa de aplicação que contém um agente ativo médico e processo para a sua disponibilização
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
WO2020148609A1 (en) * 2019-01-10 2020-07-23 Sun Pharmaceutical Industries Limited A stable aqueous injectable solution of epinephrine
WO2020232424A1 (en) 2019-05-16 2020-11-19 Nexus Pharmaceuticals, Inc. Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
AU2020325831B2 (en) * 2019-08-08 2025-09-25 Sun Pharmaceutical Industries Limited Infusion dosage form of norepinephrine
US12097170B2 (en) * 2020-03-06 2024-09-24 Baxter International Inc. Packaged, sealed container system for stable storage of an oxygen sensitive pharmaceutical formulation
JP2022530581A (ja) * 2020-04-03 2022-06-30 ファルコ-ファルマ ゲーエムベーハー オキシブチニン含有組成物で満たされた注射器、その注射器の製造方法およびその注射器を含むキット
DE102020111080A1 (de) * 2020-04-03 2021-10-07 Farco-Pharma Gmbh Spritze und Kit für die intravesikale Anwendung
US20230257183A1 (en) * 2020-06-24 2023-08-17 Nevakar Injectables Inc. Methods For Reducing Catecholamine-Formaldehyde Adducts
US20220117843A1 (en) * 2020-10-21 2022-04-21 Sintetica S.A. Ready to use, noradrenaline drip bags, having low subvisible particle counts
EP4051251B1 (en) 2020-10-21 2023-08-23 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
US12564561B2 (en) 2021-02-15 2026-03-03 Sintetica S.A. Dilute ready to use large volume containers of phenylephrine
CN117357469B (zh) * 2022-06-29 2024-09-10 南京臣功制药股份有限公司 一种盐酸肾上腺素注射液及其制备方法
MA71606A (fr) * 2022-07-25 2025-05-30 Hikma Pharmaceuticals Usa Inc. Produit prêt à être administré comprenant une formulation de norépinéphrine

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3679804A (en) * 1969-05-01 1972-07-25 Geigy Chem Corp Method for treating glaucoma with alkyl gallates
FR2779061B1 (fr) 1998-04-14 2004-08-20 Pharmatop Nouveau procede de stabilisation de composes phenoliques et les compositions pharmaceutiques en resultant
US7243689B2 (en) 2000-02-11 2007-07-17 Medical Instill Technologies, Inc. Device with needle penetrable and laser resealable portion and related method
AU2001294808A1 (en) * 2000-09-29 2002-04-08 Board Of Trustees Operating Michigan State University Catecholamine pharmaceutical compositions and methods
FR2832063B1 (fr) 2001-11-15 2004-08-27 Aguettant Lab Procede de production de solutions stables de substances phenoliques et les solutions en resultant
RU2379217C2 (ru) 2002-09-03 2010-01-20 Медикал Инстилл Текнолоджис, Инк. Пузырек в сборе для хранения вещества (варианты), устройство в сборе, содержащее пузырек, и способ заполнения пузырька
CN1634123A (zh) * 2004-10-15 2005-07-06 凌沛学 含卵磷脂和玻璃酸钠的眼科给药系统及其制备方法
DE102004063764A1 (de) * 2004-12-29 2006-07-13 Hexal Ag Kunststoff-Flasche für Oxaliplatin
US8367734B1 (en) 2005-08-11 2013-02-05 Amphastar Pharmaceuticals Inc. Stable epinephrine suspension formulation with high inhalation delivery efficiency
ES2427836T3 (es) * 2008-08-11 2013-11-04 Xiaohui Li Polipéptidos inhibidores competitivos de proteína GQ, procedimientos de preparación y usos de los mismos
AU2015202494B2 (en) 2008-12-30 2015-12-10 Xvivo Perfusion Ab A composition comprising nor-adrenaline and a NET inhibitor for administering to a brain-dead, heart-beating potential organ donor
DK2437782T3 (da) * 2009-06-04 2013-10-28 Alk Ag Stabiliseret sammensætning omfattende mindst én adrenerg forbindelse
US8628805B2 (en) * 2009-06-04 2014-01-14 Alk Ag Stabilized composition comprising at least one adrenergic compound
WO2012166227A1 (en) * 2011-06-02 2012-12-06 Procertus Biopharm, Inc. Formulation of small adrenergic agonist salt forms in organic solvents
WO2013188703A1 (en) 2012-06-13 2013-12-19 Py Daniel C Device with penetrable septum and closure needle
UY35988A (es) 2014-02-27 2015-09-30 Sint Sa Proceso para la producción de una solución inyectable de noradrenalina de baja concentración

Also Published As

Publication number Publication date
EP2990031B1 (en) 2019-11-13
JP6812094B2 (ja) 2021-01-13
EP2990031A1 (en) 2016-03-02
ES2770731T3 (es) 2020-07-02
US20180140563A1 (en) 2018-05-24
US20160058715A1 (en) 2016-03-03
JP2016050205A (ja) 2016-04-11
US11166923B2 (en) 2021-11-09
US9877935B2 (en) 2018-01-30

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