DK2626068T3 - Paracetamol til parenteral administration - Google Patents

Paracetamol til parenteral administration Download PDF

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Publication number
DK2626068T3
DK2626068T3 DK13160470.4T DK13160470T DK2626068T3 DK 2626068 T3 DK2626068 T3 DK 2626068T3 DK 13160470 T DK13160470 T DK 13160470T DK 2626068 T3 DK2626068 T3 DK 2626068T3
Authority
DK
Denmark
Prior art keywords
composition according
paracetamol
composition
mmol
infusion
Prior art date
Application number
DK13160470.4T
Other languages
English (en)
Inventor
Achleitner Georg
David Dasberg
Christiane Aichholzer
Original Assignee
Fresenius Kabi De Gmbh
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=41066778&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2626068(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Kabi De Gmbh filed Critical Fresenius Kabi De Gmbh
Application granted granted Critical
Publication of DK2626068T3 publication Critical patent/DK2626068T3/da

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Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (15)

1. Vandig farmaceutisk sammensætning i form af en infusionsopløsning, som indeholder paracetamol og har en elektrisk ledningsevne på højest 100 pS cm'1, hvorved sammensætningen ikke indeholder organiske opløsningsmidler.
2. Sammensætning ifølge krav 1, kendetegnet ved at den har en elektrisk ledningsevne på højest 50 pS cm"1.
3. Sammensætning ifølge krav 1 eller 2, kendetegnet ved at den har en bufferkapacitet β på højest 5,0 mmol Γ1 pH"1.
4. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den har en pH-værdi i området fra 5,0 til 7,0.
5. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den indeholder et ikke-ionisk isotoniseringsmiddel.
6. Sammensætning ifølge krav 5, kendetegnet ved at det ikke-ioniske isotoniseringsmiddel er en sukkeralkohol.
7. Sammensætning ifølge krav 5 eller 6, kendetegnet ved at det ikke-ioniske isotoniseringsmiddels vægtandel er større end paracetamolens vægtandel.
8. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den har en osmolaritet på mindst 0,25 osmol I"1.
9. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den praktisk talt ikke indeholder salt.
10. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at paracetamolen er tilstede i en koncentration på 10,0 ± 5,0 g I"1.
11. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at indholdet af paracetamol efter opbevaring ved 60 'C i 4 uger udgør mindst 99,0 % af det oprindelige indhold af paracetamol i sammensætningen.
12. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den er brugsklar.
13. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at den har en osmolaritet på højst 0,36 osmol Γ1.
14. Sammensætning ifølge ethvert af de foregående krav, kendetegnet ved at infusionsopløsningen er indrettet til den intravenøse infusion over et tidsrum på 2 minutter til 24 timer.
15. Sammensætning ifølge ethvert af kravene 1 til 14 til behandlingen af smerte, fortrinsvis af postoperativ smerte.
DK13160470.4T 2009-04-22 2010-04-19 Paracetamol til parenteral administration DK2626068T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP20090005630 EP2243477A1 (de) 2009-04-22 2009-04-22 Paracetamol zur parenteralen Verabreichung
EP10714862A EP2421522B1 (de) 2009-04-22 2010-04-19 Paracetamol zur parenteralen verabreichung

Publications (1)

Publication Number Publication Date
DK2626068T3 true DK2626068T3 (da) 2016-02-29

Family

ID=41066778

Family Applications (2)

Application Number Title Priority Date Filing Date
DK10714862T DK2421522T3 (da) 2009-04-22 2010-04-19 Paracetamol til parenteral administration
DK13160470.4T DK2626068T3 (da) 2009-04-22 2010-04-19 Paracetamol til parenteral administration

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK10714862T DK2421522T3 (da) 2009-04-22 2010-04-19 Paracetamol til parenteral administration

Country Status (13)

Country Link
US (2) US8741959B2 (da)
EP (3) EP2243477A1 (da)
JP (1) JP2012524738A (da)
CN (1) CN102421426A (da)
AU (1) AU2010238854B2 (da)
BR (1) BRPI1011630B8 (da)
DK (2) DK2421522T3 (da)
ES (2) ES2415354T3 (da)
HK (1) HK1166957A1 (da)
HU (1) HUE026823T2 (da)
PL (2) PL2421522T3 (da)
PT (1) PT2421522E (da)
WO (1) WO2010121762A1 (da)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20121154A1 (it) 2012-06-29 2013-12-30 Sint Sa Soluzione iniettabile di acetaminofene per la somministrazione spinale
EA028075B1 (ru) * 2014-04-29 2017-10-31 Мыкола Ивановыч ГУМЕНЮК Фармацевтическая композиция
WO2016008546A1 (en) * 2014-07-18 2016-01-21 Everbright Pharmaceuticals S.A.R.L. Aqueous formulation comprising paracetamol and ibuprofen
WO2016013049A1 (en) * 2014-07-25 2016-01-28 Terumo Kabushiki Kaisha Packaged acetaminophen injection solution preparation
EP3120837A1 (de) 2015-07-22 2017-01-25 Stada Arzneimittel Ag Verfahren zur herstellung einer bortezomibester-lösung
WO2018192664A1 (en) 2017-04-20 2018-10-25 Hyloris Developments Sa METHOD FOR PREPARING A COMPOSITION WITH A LOW DISSOLVED OXYGEN CONTENT, COMPRISING ACETAMINOPHEN, AND OPTIONALLY ONE OR MORE NSAIDs, AND A COMPOSITION OBTAINED THEREOF

Family Cites Families (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DD279405A1 (de) 1989-01-10 1990-06-06 Berlin Chemie Veb Verfahren zur herstellung eines parenteral applizierbaren analgetikums/antipyretikums
KR930011994B1 (ko) * 1991-08-16 1993-12-23 대광제약 주식회사 파라세타몰의 생체이용율을 높이는 방법 및 이 생체이용율이 높아진 파라세타몰을 함유한 제제
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JPH09286724A (ja) * 1996-04-19 1997-11-04 Takeda Chem Ind Ltd 経口用安定液剤
FR2751875B1 (fr) 1996-08-05 1998-12-24 Scr Newpharm Nouvelles formulations liquides stables a base de paracetamol et leur mode de preparation
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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
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Also Published As

Publication number Publication date
HK1166957A1 (en) 2012-11-16
JP2012524738A (ja) 2012-10-18
US20150105471A1 (en) 2015-04-16
PL2626068T3 (pl) 2016-09-30
DK2421522T3 (da) 2013-07-08
HUE026823T2 (en) 2016-07-28
EP2243477A1 (de) 2010-10-27
AU2010238854A1 (en) 2011-11-17
EP2421522B1 (de) 2013-04-03
US20120035267A1 (en) 2012-02-09
AU2010238854B2 (en) 2015-04-30
EP2626068A1 (de) 2013-08-14
WO2010121762A1 (de) 2010-10-28
PT2421522E (pt) 2013-07-08
CN102421426A (zh) 2012-04-18
BRPI1011630B1 (pt) 2020-06-23
ES2564547T3 (es) 2016-03-23
BRPI1011630B8 (pt) 2021-05-25
US8741959B2 (en) 2014-06-03
EP2421522A1 (de) 2012-02-29
PL2421522T3 (pl) 2013-08-30
ES2415354T3 (es) 2013-07-25
EP2626068B1 (de) 2015-12-09
BRPI1011630A2 (pt) 2016-03-22

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