BR112018009250A2 - formulações aperfeiçoadas de levosimendana para administração intravenosa por infusão ou injeção e de concentrados para infusão - Google Patents

formulações aperfeiçoadas de levosimendana para administração intravenosa por infusão ou injeção e de concentrados para infusão

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Publication number
BR112018009250A2
BR112018009250A2 BR112018009250-9A BR112018009250A BR112018009250A2 BR 112018009250 A2 BR112018009250 A2 BR 112018009250A2 BR 112018009250 A BR112018009250 A BR 112018009250A BR 112018009250 A2 BR112018009250 A2 BR 112018009250A2
Authority
BR
Brazil
Prior art keywords
infusion
levosimendan
present
concentrates
injection
Prior art date
Application number
BR112018009250-9A
Other languages
English (en)
Other versions
BR112018009250B1 (pt
Inventor
Weiland Andrea
Original Assignee
Carinopharm 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 Carinopharm Gmbh filed Critical Carinopharm Gmbh
Publication of BR112018009250A2 publication Critical patent/BR112018009250A2/pt
Publication of BR112018009250B1 publication Critical patent/BR112018009250B1/pt

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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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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

Landscapes

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

Abstract

a presente invenção refere-se a formulações aperfeiçoadas de levosimendana para uso farmacêutico e, em particular, para administração intravenosa na forma de infusão ou injeção e de concentrados para infusão. a presente invenção refere-se, portanto, a composições farmacêuticas que compreendem levosimendana, em que a levosimendana está presente em uma forma solubilizada. as formulações apresentam concentrações terapêuticas e comercialmente úteis de levosimendana. as soluções da presente invenção possuem aperfeiçoada aptidão em ph fisiológico (ph 7,4) e são particularmente úteis como soluções de infusão ou injeção ou concentrados para infusão. a composição de acordo com a presente invenção também pode ser seca por atomização ou liofilizada, para se obter um pó seco que é muito estável e que forma a solução original após reconstituição em água ou solvente aquoso. a levosimendana ou composto de (-)-[[4-(1,4,5,6-tetraidro-4-metil-6-oxo-3-piridazi-nil)fenil]hidrazono]propanodinitrila é de utilidade no tratamento de insuficiência cardíaca congestiva.
BR112018009250-9A 2015-11-06 2016-11-04 Formulações aperfeiçoadas de levosimendana para administração intravenosa por infusão ou injeção e de concentrados para infusão BR112018009250B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15193521.0 2015-11-06
EP15193521 2015-11-06
PCT/EP2016/076669 WO2017077032A1 (en) 2015-11-06 2016-11-04 Improved formulations of levosimendan for intravenous administration as infusion or injection and of infusion concentrate

Publications (2)

Publication Number Publication Date
BR112018009250A2 true BR112018009250A2 (pt) 2018-11-06
BR112018009250B1 BR112018009250B1 (pt) 2023-12-05

Family

ID=54476869

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018009250-9A BR112018009250B1 (pt) 2015-11-06 2016-11-04 Formulações aperfeiçoadas de levosimendana para administração intravenosa por infusão ou injeção e de concentrados para infusão

Country Status (22)

Country Link
US (1) US10507179B2 (pt)
EP (1) EP3370693B1 (pt)
JP (1) JP6770754B2 (pt)
KR (1) KR102656823B1 (pt)
CN (1) CN108289832B (pt)
AU (1) AU2016349408B2 (pt)
BR (1) BR112018009250B1 (pt)
CA (1) CA3004362C (pt)
CY (1) CY1122997T1 (pt)
DK (1) DK3370693T3 (pt)
EA (1) EA034565B1 (pt)
ES (1) ES2782106T3 (pt)
HK (1) HK1256027A1 (pt)
HR (1) HRP20200329T1 (pt)
HU (1) HUE048197T2 (pt)
LT (1) LT3370693T (pt)
ME (1) ME03761B (pt)
PL (1) PL3370693T3 (pt)
PT (1) PT3370693T (pt)
RS (1) RS60119B1 (pt)
SI (1) SI3370693T1 (pt)
WO (1) WO2017077032A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2678686C1 (ru) * 2017-09-18 2019-01-30 федеральное государственное бюджетное учреждение "Национальный медицинский исследовательский центр имени В.А. Алмазова" Министерства здравоохранения Российской Федерации Способ подготовки малого круга кровообращения реципиентов перед выполнением трансплантации сердца
WO2020041180A1 (en) * 2018-08-21 2020-02-27 Tenax Therapeutics, Inc. Pharmaceutical compositions for subcutaneous administration of levosimendan
US20220202799A1 (en) * 2019-04-16 2022-06-30 Kantum Pharma, Inc. Pharmaceutical formulations containing p2y14 antagonists
CN110742863B (zh) * 2019-11-22 2022-04-12 青海民族大学 一种槲皮素衍生物纳米胶束及其制备方法
CA3161960A1 (en) 2019-12-16 2021-06-24 Tenax Therapeutics, Inc. Levosimendan for treating pulmonary hypertension with heart failure with preserved ejection fraction (ph-hfpef)
US20220016070A1 (en) * 2020-07-17 2022-01-20 Good Health, Llc Premixed, ready to use pharmaceutical compositions of amiodarone

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DE4207922A1 (de) * 1992-03-13 1993-09-23 Pharmatech Gmbh Wasserloesliche einschlussverbindungen und verfahren zu deren herstellung
JPH0848638A (ja) * 1994-08-05 1996-02-20 Makoto Otsuka 難溶性化合物の分子化合物および難溶性化合物の溶解性改善方法
FI980902A (fi) * 1998-04-23 1999-10-24 Orion Yhtymae Oyj Levosimendaanin stabiileja koostumuksia
FI109659B (fi) * 1999-09-10 2002-09-30 Orion Yhtymae Oyj Levosimendaanin farmaseuttisia liuoksia
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Also Published As

Publication number Publication date
US20180318210A1 (en) 2018-11-08
RS60119B1 (sr) 2020-05-29
CA3004362A1 (en) 2017-05-11
AU2016349408A1 (en) 2018-04-12
HUE048197T2 (hu) 2020-07-28
HK1256027A1 (zh) 2019-09-13
CY1122997T1 (el) 2021-10-29
KR20180070667A (ko) 2018-06-26
CA3004362C (en) 2022-10-04
PL3370693T3 (pl) 2020-07-13
EA034565B1 (ru) 2020-02-20
EP3370693B1 (en) 2020-01-08
JP6770754B2 (ja) 2020-10-21
PT3370693T (pt) 2020-04-08
LT3370693T (lt) 2020-04-10
HRP20200329T1 (hr) 2020-07-24
US10507179B2 (en) 2019-12-17
SI3370693T1 (sl) 2020-07-31
WO2017077032A1 (en) 2017-05-11
JP2018535943A (ja) 2018-12-06
AU2016349408B2 (en) 2021-06-03
EA201890982A1 (ru) 2018-11-30
CN108289832B (zh) 2021-08-31
CN108289832A (zh) 2018-07-17
ME03761B (me) 2021-01-20
EP3370693A1 (en) 2018-09-12
BR112018009250B1 (pt) 2023-12-05
ES2782106T3 (es) 2020-09-10
DK3370693T3 (da) 2020-03-23
KR102656823B1 (ko) 2024-04-16

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Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

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Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/11/2016, OBSERVADAS AS CONDICOES LEGAIS