RU2011118619A - Аэрозольные фторхинолоны и их применения - Google Patents

Аэрозольные фторхинолоны и их применения Download PDF

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RU2011118619A
RU2011118619A RU2011118619/15A RU2011118619A RU2011118619A RU 2011118619 A RU2011118619 A RU 2011118619A RU 2011118619/15 A RU2011118619/15 A RU 2011118619/15A RU 2011118619 A RU2011118619 A RU 2011118619A RU 2011118619 A RU2011118619 A RU 2011118619A
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levofloxacin
ofloxacin
infection
patient
concentration
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RU2603638C2 (ru
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Марк У. СЕРБЬЕР (US)
Марк У. СЕРБЬЕР
Кит А. БОСТИАН (US)
Кит А. БОСТИАН
Ольга ЛОМОВСКАЯ (US)
Ольга ЛОМОВСКАЯ
Дэвид К. ГРИФФИТ (US)
Дэвид К. ГРИФФИТ
Майкл Н. ДАДЛИ (US)
Майкл Н. ДАДЛИ
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Эмпекс Фармасьютикалз, Инк. (Us)
Эмпекс Фармасьютикалз, Инк.
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61P31/04—Antibacterial agents
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    • 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
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    • 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

Abstract

1. Соль, выбранная из группы, состоящей из левофлоксацина ксинафоата, левофлоксацина олеата, левофлоксацина пальмитата, левофлоксацина памоата, левофлоксацина эстолата. ! 2. Сухой порошок, содержащий частицы, имеющие средний размер частиц с объемным средним диаметром от примерно 2 мкм до примерно 5 мкм и геометрическим стандартным отклонением размера частиц меньшим или равным примерно 2 мкм, где частицы содержат соль по п.1. ! 3. Фармацевтическая композиция содержащая суспензию частиц содержащую соль по п.1. ! 4. Способ лечения легочной инфекции, хронического обструктивного заболевания легких, кистозного фиброза или синусита, включающий введение аэрозоля фторхинолона в комбинации с ксинафоатом, олеатом, памоатом или эстолатом пациенту нуждающемуся в этом. ! 5. Способ по п.4, в котором фторхинолоном является левофлоксацин или офлоксацин. ! 6. Способ по п.4, в котором фторхинолон выбирают из группы, состоящей из ципрофлоксацина, гатифлоксацина, гемифлоксацина, норфлоксацина, моксифлоксацина, марбофлоксацина, орбифлоксацина, спарфлоксацина, тосуфлоксацина, тровафлоксацина, пефлоксацина, ломефлоксацина, клинафлоксацина, прулифлоксацина, сарафлоксацина, ситафлоксацина и пазуфлоксацина. ! 7. Способ лечения или профилактики микробной инфекции у пациента, включающий местное введение левофлоксацина или офлоксацина пациенту для достижения начальной концентрации в очаге инфекции приблизительно 32 мкг/мл левофлоксацина или офлоксацина. ! 8. Способ по п.7, в котором достигается начальная концентрация по меньшей мере 128 мкг/мл левофлоксацина или офлоксацина. ! 9. Способ по п.7, в котором достигается начальная концентрация по м

Claims (19)

1. Соль, выбранная из группы, состоящей из левофлоксацина ксинафоата, левофлоксацина олеата, левофлоксацина пальмитата, левофлоксацина памоата, левофлоксацина эстолата.
2. Сухой порошок, содержащий частицы, имеющие средний размер частиц с объемным средним диаметром от примерно 2 мкм до примерно 5 мкм и геометрическим стандартным отклонением размера частиц меньшим или равным примерно 2 мкм, где частицы содержат соль по п.1.
3. Фармацевтическая композиция содержащая суспензию частиц содержащую соль по п.1.
4. Способ лечения легочной инфекции, хронического обструктивного заболевания легких, кистозного фиброза или синусита, включающий введение аэрозоля фторхинолона в комбинации с ксинафоатом, олеатом, памоатом или эстолатом пациенту нуждающемуся в этом.
5. Способ по п.4, в котором фторхинолоном является левофлоксацин или офлоксацин.
6. Способ по п.4, в котором фторхинолон выбирают из группы, состоящей из ципрофлоксацина, гатифлоксацина, гемифлоксацина, норфлоксацина, моксифлоксацина, марбофлоксацина, орбифлоксацина, спарфлоксацина, тосуфлоксацина, тровафлоксацина, пефлоксацина, ломефлоксацина, клинафлоксацина, прулифлоксацина, сарафлоксацина, ситафлоксацина и пазуфлоксацина.
7. Способ лечения или профилактики микробной инфекции у пациента, включающий местное введение левофлоксацина или офлоксацина пациенту для достижения начальной концентрации в очаге инфекции приблизительно 32 мкг/мл левофлоксацина или офлоксацина.
8. Способ по п.7, в котором достигается начальная концентрация по меньшей мере 128 мкг/мл левофлоксацина или офлоксацина.
9. Способ по п.7, в котором достигается начальная концентрация по меньшей мере 512 мкг/мл левофлоксацина или офлоксацина.
10. Способ по п.7, в котором достигается начальная концентрация от 800 мкг/мл до 1600 мкг/мл левофлоксацина или офлоксацина.
11. Способ по п.7, в котором концентрация в очаге инфекции по меньшей мере 32 мкг/мл левофлоксацина или офлоксацина сохраняется в течение не более 10 минут.
12. Способ по п.7, в котором концентрация в очаге инфекции по меньшей мере 32 мкг/мл левофлоксацина или офлоксацина сохраняется в течение не более 40 минут.
13. Способ по п.7, в котором концентрация в очаге инфекции по меньшей мере 600 мкг/мл левофлоксацина или офлоксацина сохраняется в течение не более 1 часа.
14. Способ по п.7, в котором левофлоксацин или офлоксацин вводится в виде аэрозоля.
15. Способ по п.7, в котором очагом инфекции является легкое.
16. Способ лечения или профилактики микробной инфекции у пациента, включающий местное введение левофлоксацина или офлоксацина пациенту для достижения концентрации в очаге инфекции приблизительно 32 мкг/мл левофлоксацина или офлоксацина в течение не более 10 минут.
17. Способ по п.16, в котором концентрация в очаге инфекции по меньшей мере 32 мкг/мл левофлоксацина или офлоксацина сохраняется в течение не более 40 минут.
18. Способ по п.16, в котором концентрация в очаге инфекции по меньшей мере 600 мкг/мл левофлоксацина или офлоксацина сохраняется в течение не более 1 часа.
19. Способ по п.16, в котором очагом инфекции является легкое.
RU2011118619/04A 2005-05-18 2011-05-10 Аэрозольные фторхинолоны и их применения RU2603638C2 (ru)

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US60/682,530 2005-05-18
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US77330006P 2006-02-13 2006-02-13
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