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WO2008082871A1 - Formulations de levosimendan pour administration parentale - Google Patents

Formulations de levosimendan pour administration parentale Download PDF

Info

Publication number
WO2008082871A1
WO2008082871A1 PCT/US2007/087099 US2007087099W WO2008082871A1 WO 2008082871 A1 WO2008082871 A1 WO 2008082871A1 US 2007087099 W US2007087099 W US 2007087099W WO 2008082871 A1 WO2008082871 A1 WO 2008082871A1
Authority
WO
WIPO (PCT)
Prior art keywords
levosimendan
pharmaceutically acceptable
pharmaceutical composition
acid
composition
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/US2007/087099
Other languages
English (en)
Inventor
Jitendra Patel
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.)
Orion Oyj
Abbott Laboratories
Original Assignee
Orion Oyj
Abbott Laboratories
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 Orion Oyj, Abbott Laboratories filed Critical Orion Oyj
Priority to JP2009544153A priority Critical patent/JP2010514778A/ja
Publication of WO2008082871A1 publication Critical patent/WO2008082871A1/fr
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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/50—Pyridazines; Hydrogenated pyridazines
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure

Definitions

  • an organic acid may be combined with the organic solvent (prior to combining with the drug) or after the drug is combined with the organic solvent (i.e.
  • the organic solvent may be packaged as one component and the levosimendan packaged as a separate component.
  • the packaged pharmaceutical product or kit may further comprise instructions for combining the materials of the product or kit. It may optionally comprise a diluent for diluting the composition to a concentration that can be administered to a patient or the diluent may be supplied as a separate component. Any suitable combinations of packaging the pharmaceutical product are envisioned. Most preferably, the diluent is maintained as a separate component (as part of the packaged pharmaceutical kit or otherwise) and is used immediately prior to administration.
  • Levosimendan can be administered intravenously at an infusion rate in the range of about 0.005-100 micrograms/kilogram/minute (mcg/kg/min), typically 0.01 to 10 mcg/kg/min, more typically about 0.02 to 1 mcg/kg/min.
  • an infusion rate in the range of about 0.005-100 micrograms/kilogram/minute (mcg/kg/min), typically 0.01 to 10 mcg/kg/min, more typically about 0.02 to 1 mcg/kg/min.
  • the suitable rate is 0.05-0.4 mcg/kg/min of levosimendan.
  • a preferred formulation of levosimendan (2.5 mg/mL) in dehydrated ethyl alcohol was evaluated in several preliminary compatibility studies by diluting the formulation to a concentration of 0.05 mg/mL.
  • the primary purpose was to demonstrate suitability of use over a 24-48 hour period post-dilution in Neut® buffered saline (5 mL per 500 mL diluent) solutions in different types of IV containers.
  • SIMD AX® was included in the studies as a reference formulation.
  • the studies evaluated visual clarity, pH and sub- visual particulate by light obscuration (HIAC) techniques.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cardiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques de levosimendan, en particulier pour administration intraveineuse, et des procédés de préparation de ces compositions. Selon l'invention, ces compositions offrent une solubilité et une stabilité accrues sans l'utilisation d'agents facilitant la solubilité.
PCT/US2007/087099 2006-12-28 2007-12-12 Formulations de levosimendan pour administration parentale Ceased WO2008082871A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2009544153A JP2010514778A (ja) 2006-12-28 2007-12-12 非経口投与のためのレボシメンダン製剤

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US88231106P 2006-12-28 2006-12-28
US60/882,311 2006-12-28

Publications (1)

Publication Number Publication Date
WO2008082871A1 true WO2008082871A1 (fr) 2008-07-10

Family

ID=39588963

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/087099 Ceased WO2008082871A1 (fr) 2006-12-28 2007-12-12 Formulations de levosimendan pour administration parentale

Country Status (2)

Country Link
JP (1) JP2010514778A (fr)
WO (1) WO2008082871A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012093404A3 (fr) * 2011-01-03 2012-11-08 Gufic Biosciences Limited Formulations parentérales de lévosimendane
CN105106113A (zh) * 2015-09-30 2015-12-02 济南康和医药科技有限公司 一种左西孟旦注射液及其制备方法
US9808529B2 (en) 2012-05-18 2017-11-07 Luoda Pharma Pty Ltd Liquid formulation
US11607412B2 (en) 2019-12-16 2023-03-21 Tenax Therapeutics Inc. Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)
WO2024183828A1 (fr) * 2023-05-17 2024-09-12 山东泰合医药科技有限公司 Lévosimendan pour injection et son procédé de préparation

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118717662B (zh) * 2024-06-24 2025-05-16 郑州市中心医院 一种左西孟旦注射剂及其制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040106617A1 (en) * 1999-09-10 2004-06-03 Orion Corporation Pharmaceutical solutions of levosimendan
US20050255096A1 (en) * 2002-02-01 2005-11-17 Pentti Poder Combination treatment for acute myocardial infarction

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI20040674A0 (fi) * 2004-05-12 2004-05-12 Orion Corp Menetelmä tromboembolisten sairauksien estoon
CN101031302A (zh) * 2004-05-28 2007-09-05 艾博特公司 用于治疗心脏停搏前、期间和之后的哺乳动物的方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040106617A1 (en) * 1999-09-10 2004-06-03 Orion Corporation Pharmaceutical solutions of levosimendan
US20050255096A1 (en) * 2002-02-01 2005-11-17 Pentti Poder Combination treatment for acute myocardial infarction

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012093404A3 (fr) * 2011-01-03 2012-11-08 Gufic Biosciences Limited Formulations parentérales de lévosimendane
US9808529B2 (en) 2012-05-18 2017-11-07 Luoda Pharma Pty Ltd Liquid formulation
US10413610B2 (en) 2012-05-18 2019-09-17 Luoda Pharma Limited Liquid formulation
US11357855B2 (en) 2012-05-18 2022-06-14 Luoda Pharma Limited Liquid formulation
CN105106113A (zh) * 2015-09-30 2015-12-02 济南康和医药科技有限公司 一种左西孟旦注射液及其制备方法
US11607412B2 (en) 2019-12-16 2023-03-21 Tenax Therapeutics Inc. Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)
US11701355B2 (en) 2019-12-16 2023-07-18 Tenax Therapeutics, Inc. Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)
US11969424B2 (en) 2019-12-16 2024-04-30 Tenax Therapeutics, Inc. Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF)
WO2024183828A1 (fr) * 2023-05-17 2024-09-12 山东泰合医药科技有限公司 Lévosimendan pour injection et son procédé de préparation

Also Published As

Publication number Publication date
JP2010514778A (ja) 2010-05-06

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