DK2594272T3 - Aerosoliserede fluorquinoloner og anvendelser deraf - Google Patents

Aerosoliserede fluorquinoloner og anvendelser deraf Download PDF

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Publication number
DK2594272T3
DK2594272T3 DK12007354.9T DK12007354T DK2594272T3 DK 2594272 T3 DK2594272 T3 DK 2594272T3 DK 12007354 T DK12007354 T DK 12007354T DK 2594272 T3 DK2594272 T3 DK 2594272T3
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levofloxacin
solution
aerosol
fluoroquinolone
mosmol
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DK12007354.9T
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English (en)
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Keith A Bostian
Michael N Dudley
Mark Surber
David C Griffith
Olga Lomovskaya
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Horizon Orphan Llc
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    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/538—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with carbocyclic ring systems
    • 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
    • A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
    • 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
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D498/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D498/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms in which the condensed system contains two hetero rings
    • C07D498/06—Peri-condensed systems
    • 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Dispersion Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)

Claims (16)

1. Fremgangsmåde til fremstilling afen aerosol afen opløsning omfattende levofloxacin eller ofloxacin og en divalent eller trivalent kation, hvor nævnte fremgangsmåde omfatter: opnåelse afen opløsning omfattende levofloxacin eller ofloxacin og en divalent eller trivalent kation; og aerosolisering af nævnte opløsning for at opnå en aerosol omfattende en aerodynamisk massemediandiameter på 5pm eller mindre, hvor nævnte aerosol er egnet til inhalering ind i en lunge.
2. Fremgangsmåden ifølge krav 1, hvor nævnte aerosolisering omfatter at forstøve nævnte opløsning med en forstøver, fortrinsvis en vibrerende netforstøver eller en kompressor-dreven forstøver.
3. Fremgangsmåden ifølge et hvilket som helst af kravene 1-2, hvor den divalente eller trivalente kation er valgt fra gruppen bestående af magnesium, calcium, aluminium, zink og jern.
4. Fremgangsmåden ifølge et hvilket som helst af kravene 1-3, hvor opløsningen har en permeabiliserende ionkoncentration fra omkring 25 mM til omkring 400 mM, fortrinsvis fra omkring 30 mM til omkring 300 mM, mere foretrukket fra omkring 40 mM til omkring 200 mM.
5. Fremgangsmåden ifølge krav 4, hvor den permeabiliserende ion er valgt fra chlorid og bromid.
6. Fremgangsmåden ifølge et hvilket som helst af kravene 1-5, hvor opløsningen har en koncentration af levofloxacin eller ofloxacin på omkring 1 mg/ml til omkring 700 mg/ml, fortrinsvis omkring 7 mg/ml til 700 mg/ml, fortrinsvis større end omkring 25 mg/ml, mere foretrukket større end omkring 35 mg/ml, endnu mere foretrukket større end omkring 40 mg/ml, yderst foretrukket større end omkring 50 mg/ml, og/eller eventuelt hvor opløsningen har en osmolalitet fra omkring 200 mOsmol/kg til omkring 1250 mOsmol/kg, fortrinsvis fra omkring 250 mOsmol/kg til omkring 1050 mOsmol/kg, mere foretrukket fra omkring 350 mOsmol/kg til omkring 750 mOsmol/kg; og/eller eventuelt hvor opløsningen har en pH fra omkring 4,5 til omkring 7,5, fortrinsvis fra omkring 5,5 til omkring 7,0, mere foretrukket fra omkring 5,5 til omkring 6,5.
7. Fremgangsmåden ifølge et hvilket som helst af kravene 1-6, hvor opløsningen omfatter magnesium og mere end omkring 50 mg/ml levofloxacin, og har en osmolalitet fra omkring 350 mOsmol/kg til omkring 750 mOsmol/kg, og en pH fra omkring 5,5 til omkring 6,5.
8. Fremgangsmåden ifølge et hvilket som helst af kravene 1-7, hvor aerosolen har en aerodynamisk massemediandiameter fra omkring 2 mikrometer til omkring 5 mikrometer med en geometrisk standardafvigelse mindre end eller lig med omkring 2,5 mikrometer, fortrinsvis fra omkring 2,5 mikrometer til omkring 4,5 mikrometer med en geometrisk standardafvigelse mindre end eller lig med omkring 1,8 mikrometer, mere foretrukket fra omkring 2,8 mikrometer til omkring 4,3 mikrometer med en geometrisk standardafvigelse mindre end eller lig med omkring 2 mikrometer.
9. Fremgangsmåden ifølge et hvilket som helst af kravene 1-8, hvor opløsningen yderligere omfatter en komponent valgt fra gruppen bestående af et sødemiddel, et andet antimikrobielt middel, dornasealpha, en hypertonisk formulering, mannitol og natriumchlorid.
10. Fremgangsmåden ifølge krav 9, hvor det andet antimikrobielle middel er valgt fra gruppen bestående af et aminoglycosid, polymyxin, monobactam, makrolid, ketolid, glycopeptid, og fluorquinolon.
11. Fremgangsmåden ifølge krav 9, hvor aminoglycosidet er tobramycin, polymyxinet er colistin, monobactammet er aztreonam, glycopeptidet er vancomycin eller fluorquinolonet er valgt fra gruppen bestående af lomefloxacin, pefloxacin, ciprofloxacin, gatifloxacin, gemifloxacin, moxifloxacin, tosufloxacin, pazufloxacin, rufloxacin, fleroxacin, balofloxacin, sparfloxacin, trovafloxacin, enoxacin, norfloxacin, clinafloxacin, grepafloxacin, sitafloxacin, temafloxacin, marbofloxacin, orbifloxacin, sarafloxacin, danofloxacin, difloxacin, enrofloxacin, garenoxacin, prulifloxacin, olamufloxacin, DX-619, TG-873870 og DW-286.
12. Farmaceutisk sammensætning, omfattende en vandig opløsning af levofloxacin eller ofloxacin og en divalent eller trivalent kation, hvor opløsningen er egnet til inhalering ind i en lunge.
13. Den farmaceutiske sammensætning ifølge krav 12, omfattende en vandig opløsning af levofloxacin og en divalent eller trivalent kation.
14. Den farmaceutiske sammensætning ifølge krav 13, hvor den divalente eller trivalente kation er valgt fra Mg2+, Ca2+, Zn2+, Fe2+ og Al3+.
15. Den farmaceutiske sammensætning ifølge krav 12 eller krav 13, hvor kationen er en divalent kation valgt fra magnesium eller calcium.
16. Den farmaceutiske sammensætning ifølge krav 13, hvor kationen er Mg2+.
DK12007354.9T 2005-05-18 2006-05-18 Aerosoliserede fluorquinoloner og anvendelser deraf DK2594272T3 (da)

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US68253005P 2005-05-18 2005-05-18
US69616005P 2005-07-01 2005-07-01
US77330006P 2006-02-13 2006-02-13
EP06760146.8A EP1901749B1 (en) 2005-05-18 2006-05-18 Aerosolized fluoroquinolones and uses thereof

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EP (2) EP2594272B1 (da)
JP (2) JP5279487B2 (da)
KR (3) KR101488402B1 (da)
CN (2) CN101222927B (da)
AU (1) AU2006247053B2 (da)
CA (2) CA2900093C (da)
CY (2) CY1118137T1 (da)
DK (2) DK1901749T3 (da)
ES (2) ES2599313T3 (da)
HR (1) HRP20161230T2 (da)
HU (3) HUE038814T2 (da)
IL (3) IL187346A (da)
LT (2) LT1901749T (da)
LU (1) LUC00004I2 (da)
ME (1) ME02562B (da)
MX (1) MX359219B (da)
NZ (3) NZ563417A (da)
PL (2) PL2594272T3 (da)
PT (2) PT2594272T (da)
RS (1) RS55114B1 (da)
RU (2) RU2603638C2 (da)
SI (1) SI2594272T1 (da)
WO (1) WO2006125132A2 (da)

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