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WO2002072080A3 - Paracetamol solutions which are stable in storage and ready for infusion - Google Patents

Paracetamol solutions which are stable in storage and ready for infusion Download PDF

Info

Publication number
WO2002072080A3
WO2002072080A3 PCT/EP2002/002696 EP0202696W WO02072080A3 WO 2002072080 A3 WO2002072080 A3 WO 2002072080A3 EP 0202696 W EP0202696 W EP 0202696W WO 02072080 A3 WO02072080 A3 WO 02072080A3
Authority
WO
WIPO (PCT)
Prior art keywords
solutions
stable
per litre
storage
paracetamol
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2002/002696
Other languages
German (de)
French (fr)
Other versions
WO2002072080A2 (en
Inventor
Bernd Eschenbach
Hans-Joerg Mueller
Klaus Sommermeyer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland 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
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP02724223A priority Critical patent/EP1372628A2/en
Priority to AU2002254942A priority patent/AU2002254942A1/en
Publication of WO2002072080A2 publication Critical patent/WO2002072080A2/en
Publication of WO2002072080A3 publication Critical patent/WO2002072080A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K9/08—Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to parenterally administrable, especially infusible, aqueous paracetamol solutions which are stable in storage and free of particles and discoloration. Said solutions contain a mixture of: a) between 1 and 17 grams of paracetamol per litre, and b) between 0.01 and 0.17 grams of at least one physiologically compatible antioxidant per litre, selected from the group comprising ascorbic acid, N-acetyl-L-cysteine and stabiliser compounds containing SH groups which are different from N-acetyl-L-cysteine. The aqueous solution is free of organic solvents and has a pH value of between 5.5 and 6.5 and an oxygen content of less than 0.5 milligrams per litre. The invention also relates to a method for producing such solutions, and glass or plastic containers containing said solutions.
PCT/EP2002/002696 2001-03-13 2002-03-12 Paracetamol solutions which are stable in storage and ready for infusion Ceased WO2002072080A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP02724223A EP1372628A2 (en) 2001-03-13 2002-03-12 Paracetamol solutions which are stable in storage and ready for infusion
AU2002254942A AU2002254942A1 (en) 2001-03-13 2002-03-12 Paracetamol solutions which are stable in storage and ready for infusion

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10112325.6 2001-03-13
DE10112325A DE10112325A1 (en) 2001-03-13 2001-03-13 Storage stable ready-to-use infusion solutions of paracetamol

Publications (2)

Publication Number Publication Date
WO2002072080A2 WO2002072080A2 (en) 2002-09-19
WO2002072080A3 true WO2002072080A3 (en) 2002-11-28

Family

ID=7677473

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2002/002696 Ceased WO2002072080A2 (en) 2001-03-13 2002-03-12 Paracetamol solutions which are stable in storage and ready for infusion

Country Status (4)

Country Link
EP (1) EP1372628A2 (en)
AU (1) AU2002254942A1 (en)
DE (1) DE10112325A1 (en)
WO (1) WO2002072080A2 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6566401B2 (en) 2001-03-30 2003-05-20 The Board Of Trustees Of The Leland Stanford Junior University N-acetylcysteine compositions and methods for the treatment and prevention of drug toxicity
ITMI20012135A1 (en) 2001-10-16 2003-04-16 Bioren S A INJECTABLE SOLUTIONS READY TO USE PARACETAMOL
FR2851164B1 (en) * 2003-02-14 2005-04-22 Xuan Tho Nguyen INFLATABLE LIQUID FORMULATION OF PARACETAMOL
DE102005037653A1 (en) 2005-08-05 2007-02-15 Theraselect Gmbh Stable, liquid formulation of paracetamol
AU2006346318B2 (en) * 2006-07-18 2011-02-10 Genfarma Laboratorio S.L. Injectable liquid paracetamol formulation
EP1992334A1 (en) * 2007-05-08 2008-11-19 Docpharma NV/SA Storage-stable formulation of oxidation-sensitive phenolic drug, especially paracetamol, comprises aqueous drug solution deoxygenated by a temperature-controlled manufacturing process of the formulation
WO2009098716A2 (en) * 2008-01-17 2009-08-13 Aptuit Laurus Private Limited Stable pharmaceutical aqueous compositions
EP2243477A1 (en) 2009-04-22 2010-10-27 Fresenius Kabi Deutschland GmbH Paracetamol for parenteral application
EP2464332B2 (en) 2009-08-13 2025-10-15 Neogen N.V. Method for producing a storage-stable formulation of paracetamol in aqueous solution
US8404748B2 (en) 2009-08-13 2013-03-26 Neogen N.V. Storage-stable formulation of paracetamol in aqueous solution
CN102711726A (en) * 2009-12-10 2012-10-03 特克尼梅德医疗技术股份公司 Methods and compositions for the preparation of stable liquid formulations of paracetamol
EP2377516B1 (en) * 2010-04-14 2012-06-20 B. Braun Melsungen AG Acetaminophen composition
CN103476395A (en) 2011-02-10 2013-12-25 尼奥根公司 Storage-stable formulation of paracetamol in aqueous solution
KR102051800B1 (en) 2011-03-04 2019-12-04 그뤼넨탈 게엠베하 Aqueous pharmaceutical formulation of tapentadol for oral administration
ES2414557B1 (en) 2012-01-16 2014-06-10 Novocat Farma, S.A. Aqueous composition of paracetamol for injection
ITMI20121154A1 (en) * 2012-06-29 2013-12-30 Sint Sa INJECTABLE ACETAMINOFENE SOLUTION FOR SPINAL ADMINISTRATION
EA028075B1 (en) * 2014-04-29 2017-10-31 Мыкола Ивановыч ГУМЕНЮК Pharmaceutical composition
PT3273953T (en) 2015-03-27 2019-04-01 Gruenenthal Gmbh Stable formulation for parenteral administration of tapentadol
BR112019005439A2 (en) 2016-09-23 2019-06-18 Gruenenthal Gmbh stable formulation for parenteral administration of tapentadol
CN112782332A (en) * 2021-02-04 2021-05-11 深圳市药品检验研究院（深圳市医疗器械检测中心） HPLC (high performance liquid chromatography) detection method for p-aminophenol impurities in acetaminophen medicine

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0916347A1 (en) * 1997-11-18 1999-05-19 Uni-Pharma Kleon Tsetis A.B.E.E., Farmakeftika Ergastiria Pharmaceutical injectable solutions containing paracetamol and combinations of paracetamol with other active substances
US6028222A (en) * 1996-08-05 2000-02-22 Scr Pharmatop Stable liquid paracetamol compositions, and method for preparing same

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6028222A (en) * 1996-08-05 2000-02-22 Scr Pharmatop Stable liquid paracetamol compositions, and method for preparing same
EP0916347A1 (en) * 1997-11-18 1999-05-19 Uni-Pharma Kleon Tsetis A.B.E.E., Farmakeftika Ergastiria Pharmaceutical injectable solutions containing paracetamol and combinations of paracetamol with other active substances

Also Published As

Publication number Publication date
AU2002254942A1 (en) 2002-09-24
WO2002072080A2 (en) 2002-09-19
DE10112325A1 (en) 2002-10-02
EP1372628A2 (en) 2004-01-02

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