DK2277546T3 - Stabil, klar til brug, injicerbar paracetamol-formulering - Google Patents

Stabil, klar til brug, injicerbar paracetamol-formulering Download PDF

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Publication number
DK2277546T3
DK2277546T3 DK09009569.6T DK09009569T DK2277546T3 DK 2277546 T3 DK2277546 T3 DK 2277546T3 DK 09009569 T DK09009569 T DK 09009569T DK 2277546 T3 DK2277546 T3 DK 2277546T3
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DK
Denmark
Prior art keywords
solution
paracetamol
stable
edta
hydroxypropyl
Prior art date
Application number
DK09009569.6T
Other languages
English (en)
Inventor
Ioulia Tseti
Original Assignee
Uni Pharma Kleon Tsetis Pharmaceutical Lab S A
Ioulia Tseti
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 Uni Pharma Kleon Tsetis Pharmaceutical Lab S A, Ioulia Tseti filed Critical Uni Pharma Kleon Tsetis Pharmaceutical Lab S A
Application granted granted Critical
Publication of DK2277546T3 publication Critical patent/DK2277546T3/da

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
    • 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
    • A61K47/16—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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nanotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (1)

1. Stabil vandig paracetamoloplosning til anvendelse ved IV infusión omfattende 2-hydroxypropyl-beta-cyclodextrin som en stabiliserings-oplosende forbindelse hvor det molaere forhold af paracetamol til 2-hydroxypropyl-beta-cyclodextrin er 100:1 til 0,1:1, og den vandige oplosning omfatter 2 mg til 200 mg paracetamol pr. mi oplosning, yderligere omfattende EDTA og monothioglycerol som stabiliserende forbindelser, hvor koncentrationen af EDTA er 0,0015 mg til 1 mg pr. mi oplosning og koncentrationen af monothioglycerol er 0,015 mg til 1 mg pr. mi oplosning.
DK09009569.6T 2009-07-23 2009-07-23 Stabil, klar til brug, injicerbar paracetamol-formulering DK2277546T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP09009569.6A EP2277546B1 (en) 2009-07-23 2009-07-23 Stable ready to use injectable paracetamol formulation

Publications (1)

Publication Number Publication Date
DK2277546T3 true DK2277546T3 (da) 2015-08-17

Family

ID=41264251

Family Applications (1)

Application Number Title Priority Date Filing Date
DK09009569.6T DK2277546T3 (da) 2009-07-23 2009-07-23 Stabil, klar til brug, injicerbar paracetamol-formulering

Country Status (10)

Country Link
EP (1) EP2277546B1 (da)
CY (1) CY1116746T1 (da)
DK (1) DK2277546T3 (da)
ES (1) ES2545484T3 (da)
HR (1) HRP20150815T1 (da)
HU (1) HUE027032T2 (da)
PL (1) PL2277546T3 (da)
PT (1) PT2277546E (da)
SI (1) SI2277546T1 (da)
SM (1) SMT201500192B (da)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2414557B1 (es) 2012-01-16 2014-06-10 Novocat Farma, S.A. Composición acuosa de paracetamol para inyección
ZA201300398B (en) * 2012-11-27 2013-09-25 Genfarma Laboratories S L Injectable liquid formulation of the combination of tramadol and paracetamol
US12527755B2 (en) * 2016-09-16 2026-01-20 Cydex Pharmaceuticals, Inc. Formulations containing acetaminophen and sulfoalkyl ether cyclodextrin
GR1010637B (el) * 2023-01-13 2024-02-15 Ιουλια Κλεωνος Τσετη Σταθερο υδατικο διαλυμα παρακεταμολης για χρηση σε ενδοφλεβια εγχυση
IL324832A (en) 2023-06-02 2026-01-01 Ioulia Tseti Pharmaceutical composition comprising ibuprofen

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
FR2751875B1 (fr) * 1996-08-05 1998-12-24 Scr Newpharm Nouvelles formulations liquides stables a base de paracetamol et leur mode de preparation
EA006939B1 (ru) * 2001-12-18 2006-06-30 Юни-Фарма Клеон Цетис Фармасьютикал Лэборетериз С. А. Парентеральная композиция парацетамола
CN1232539C (zh) * 2002-05-10 2005-12-21 刘云清 有机药物与倍他环糊精衍生物的配合物及其制备方法
WO2008021896A2 (en) * 2006-08-08 2008-02-21 Board Of Supervisors Of Louisiana State University And Agricultural And Mechanical College Therapeutic methods for neuropathic pain
JP5909750B2 (ja) * 2007-11-13 2016-04-27 マリンクロット アイピー 低用量静脈内アセトアミノフェン

Also Published As

Publication number Publication date
SMT201500192B (it) 2015-09-07
HRP20150815T1 (hr) 2015-09-11
PT2277546E (pt) 2015-09-25
HK1153400A1 (en) 2012-03-30
ES2545484T3 (es) 2015-09-11
EP2277546B1 (en) 2015-07-15
SI2277546T1 (sl) 2015-09-30
CY1116746T1 (el) 2017-03-15
EP2277546A1 (en) 2011-01-26
PL2277546T3 (pl) 2015-10-30
HUE027032T2 (en) 2016-08-29

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