RU2015130524A - Применение левофлоксацина в форме аэрозоля для лечения муковисцидоза - Google Patents
Применение левофлоксацина в форме аэрозоля для лечения муковисцидоза Download PDFInfo
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- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 title claims 22
- 229960003376 levofloxacin Drugs 0.000 title claims 22
- 239000000443 aerosol Substances 0.000 title claims 14
- 201000003883 Cystic fibrosis Diseases 0.000 title claims 12
- 238000000034 method Methods 0.000 claims 25
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 claims 21
- 229960001699 ofloxacin Drugs 0.000 claims 21
- 150000001768 cations Chemical class 0.000 claims 18
- 208000015181 infectious disease Diseases 0.000 claims 7
- 230000002685 pulmonary effect Effects 0.000 claims 7
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 4
- 206010036790 Productive cough Diseases 0.000 claims 4
- 210000003802 sputum Anatomy 0.000 claims 4
- 208000024794 sputum Diseases 0.000 claims 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 239000008101 lactose Substances 0.000 claims 2
- 210000004072 lung Anatomy 0.000 claims 2
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 241000588624 Acinetobacter calcoaceticus Species 0.000 claims 1
- 241001148231 Acinetobacter haemolyticus Species 0.000 claims 1
- 241000607528 Aeromonas hydrophila Species 0.000 claims 1
- 241000894006 Bacteria Species 0.000 claims 1
- 241000588779 Bordetella bronchiseptica Species 0.000 claims 1
- 241000588780 Bordetella parapertussis Species 0.000 claims 1
- 241000588832 Bordetella pertussis Species 0.000 claims 1
- 241000589969 Borreliella burgdorferi Species 0.000 claims 1
- 241000589513 Burkholderia cepacia Species 0.000 claims 1
- 241000589877 Campylobacter coli Species 0.000 claims 1
- 241000589874 Campylobacter fetus Species 0.000 claims 1
- 241000589875 Campylobacter jejuni Species 0.000 claims 1
- 241000588919 Citrobacter freundii Species 0.000 claims 1
- 241001600125 Delftia acidovorans Species 0.000 claims 1
- XRHVZWWRFMCBAZ-UHFFFAOYSA-L Endothal-disodium Chemical compound [Na+].[Na+].C1CC2C(C([O-])=O)C(C(=O)[O-])C1O2 XRHVZWWRFMCBAZ-UHFFFAOYSA-L 0.000 claims 1
- 241000588697 Enterobacter cloacae Species 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- 241000589602 Francisella tularensis Species 0.000 claims 1
- 241000606788 Haemophilus haemolyticus Species 0.000 claims 1
- 241000606768 Haemophilus influenzae Species 0.000 claims 1
- 241000606822 Haemophilus parahaemolyticus Species 0.000 claims 1
- 241000606766 Haemophilus parainfluenzae Species 0.000 claims 1
- 241000590002 Helicobacter pylori Species 0.000 claims 1
- 241001454354 Kingella Species 0.000 claims 1
- 241000588748 Klebsiella Species 0.000 claims 1
- 241000588915 Klebsiella aerogenes Species 0.000 claims 1
- 241000588747 Klebsiella pneumoniae Species 0.000 claims 1
- 241000589242 Legionella pneumophila Species 0.000 claims 1
- 241000186779 Listeria monocytogenes Species 0.000 claims 1
- 241001293418 Mannheimia haemolytica Species 0.000 claims 1
- 241000588621 Moraxella Species 0.000 claims 1
- 241000588652 Neisseria gonorrhoeae Species 0.000 claims 1
- 108010067035 Pancrelipase Proteins 0.000 claims 1
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- 241000589776 Pseudomonas putida Species 0.000 claims 1
- 241001354013 Salmonella enterica subsp. enterica serovar Enteritidis Species 0.000 claims 1
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- 241000293871 Salmonella enterica subsp. enterica serovar Typhi Species 0.000 claims 1
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- 241000607479 Yersinia pestis Species 0.000 claims 1
- 241000607477 Yersinia pseudotuberculosis Species 0.000 claims 1
- YYAZJTUGSQOFHG-IAVNQIGZSA-N [(6s,8s,10s,11s,13s,14s,16r,17r)-6,9-difluoro-17-(fluoromethylsulfanylcarbonyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate;2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]eth Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)C1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O YYAZJTUGSQOFHG-IAVNQIGZSA-N 0.000 claims 1
- 241000606834 [Haemophilus] ducreyi Species 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims 1
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- 229940065524 anticholinergics inhalants for obstructive airway diseases Drugs 0.000 claims 1
- 239000004599 antimicrobial Substances 0.000 claims 1
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 claims 1
- 229960004099 azithromycin Drugs 0.000 claims 1
- 229940124630 bronchodilator Drugs 0.000 claims 1
- 239000000168 bronchodilator agent Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 239000000812 cholinergic antagonist Substances 0.000 claims 1
- 108010067396 dornase alfa Proteins 0.000 claims 1
- 150000002066 eicosanoids Chemical class 0.000 claims 1
- 229940092559 enterobacter aerogenes Drugs 0.000 claims 1
- 229940118764 francisella tularensis Drugs 0.000 claims 1
- 239000003862 glucocorticoid Substances 0.000 claims 1
- 229940047650 haemophilus influenzae Drugs 0.000 claims 1
- 229940037467 helicobacter pylori Drugs 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 229940115932 legionella pneumophila Drugs 0.000 claims 1
- 239000012528 membrane Substances 0.000 claims 1
- 239000006199 nebulizer Substances 0.000 claims 1
- 229940045258 pancrelipase Drugs 0.000 claims 1
- 229940051027 pasteurella multocida Drugs 0.000 claims 1
- 230000000241 respiratory effect Effects 0.000 claims 1
- 210000002345 respiratory system Anatomy 0.000 claims 1
- 229960002052 salbutamol Drugs 0.000 claims 1
- 229940007046 shigella dysenteriae Drugs 0.000 claims 1
- 229940115939 shigella sonnei Drugs 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 229960002668 sodium chloride Drugs 0.000 claims 1
- 229940037128 systemic glucocorticoids Drugs 0.000 claims 1
- 235000019155 vitamin A Nutrition 0.000 claims 1
- 239000011719 vitamin A Substances 0.000 claims 1
- 229940098232 yersinia enterocolitica Drugs 0.000 claims 1
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- 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
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Claims (28)
1. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением снижения плотности P. aeruginosa в мокроте указанного человека по меньшей мере на 0,25 log10 КОЕ/г мокроты.
2. Способ по п. 1, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
3. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения FEV1 (объем форсированного выдоха за 1 секунду) по меньшей мере на 2% и увеличения FEF 25-75 (средняя объемная скорость форсированного выдоха в интервале 25-75% жизненной емкости легких) по меньшей мере на 5%, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
4. Способ по п. 3, включающий достижение увеличения FEV1 по меньшей мере на 0,05 л и увеличения FEF 25-75 по меньшей мере на 0,05 л.
5. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением относительного риска менее 1,0, где относительный риск является показателем снижения потребности в других антипсевдомонадных противомикробных средствах, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
6. Способ лечения муковисцидоза у человека, которому посредством ингаляции вводят агент, выбранный из группы, состоящей из
одного или более из следующих: дорназа альфа, азитромицин, сальбутамол, панкрелипаза, хлорид натрия, серетид и ADEK (витамины A, D, E, K), включающий введение указанному человеку аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
7. Способ по п. 6, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa.
8. Способ по п. 7, включающий достижение снижения плотности Р. aeruginosa в мокроте указанного человека по меньшей мере на 0,25 log10 КОЕ/г мокроты.
9. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa, включающий повторяющееся введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, где указанное повторяющееся введение не приводит у указанного человека к более чем 16-кратному увеличению минимальной ингибирующей концентрации (MIC) в отношении штамма P. aeruginosa, который характеризуется наивысшей MIC относительно других штаммов P. aeruginosa, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
10. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa, включающий определение дозы аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, для достижения увеличения в респираторной части CFQ-R (вопросник для пациентов с муковисцидозом, пересмотренный вариант) более чем на 1 и повторяющееся введение этой дозы указанному человеку, нуждающемуся в этом, для лечения муковисцидоза, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до
примерно 200 мг/мл.
11. Способ снижения сопротивления малых дыхательных путей у человека с муковисцидозом, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения FEF 25-75 по меньшей мере на 5%, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
12. Способ по п. 11, включающий достижение увеличения FEF 25-75 по меньшей мере на 0,05 л.
13. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa, и указанный человек имеет площадь поверхности тела менее 1,5 м2, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением приведенной к дозе сывороточной AUC (площадь под кривой) по меньшей мере 20 (нг.ч/л)/мг дозы, где указанный аэрозоль содержит по меньшей мере 80 мг левофлоксацина или офлоксацина, и где указанное введение повторяют один раз в сутки в течение по меньшей мере 14 суток.
14 Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую P. aeruginosa, и указанный человек имеет площадь поверхности тела менее 1,5 м2, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением приведенной к дозе сывороточной Cmax (максимальная концентрация) более чем 2 мкг/л/мг введенной дозы, где указанный раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
15. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где раствор состоит по существу из левофлоксацина или офлоксацина и двухвалентного или трехвалентного катиона.
16. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где раствор не содержит лактозу.
17. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где раствор имеет осмоляльность от примерно 300 мосмоль/кг до примерно 500 мосмоль/кг и pH от примерно 5 до примерно 8.
18. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где раствор содержит хлорид магния.
19. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где раствор имеет концентрацию левофлоксацина или офлоксацина от примерно 90 мг/мл до примерно 110 мг/мл, концентрацию хлорида магния от примерно 175 мМ до примерно 225 мМ, pH от примерно 5 до примерно 7, осмоляльность от примерно 300 мосмоль/кг до примерно 500 мосмоль/кг и не содержит лактозу.
20. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где аэрозоль имеет масс-медианный аэродинамический диаметр от примерно 2 микрон до примерно 5 микрон с геометрическим стандартным отклонением, которое меньше или равно примерно 2,5 микрон.
21. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, включающий получение аэрозоля с использованием небулайзера с вибрирующей сеткой-мембраной.
22. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где по меньшей мере примерно 20 мг левофлоксацина или офлоксацина вводят в легкое.
23. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, дополнительно включающий совместное введение дополнительного активного агента, выбранного из группы, состоящей из антибиотиков, бронхорасширяющих средств, антихолинергических агентов, глюкокортикоидов, ингибиторов эйкозаноидов и их комбинаций.
24. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, включающий введение аэрозоля один раз в сутки.
25. Способ по любому из пп. 1, 3, 5, 6, 9, 10, 11, 13 и 14, где легочная инфекция дополнительно включает одну или более бактерий, выбранных из группы, состоящей из Pseudomonas fluorescens, Pseudomonas acidovorans, Pseudomonas alcaligenes и Pseudomonas putida, Stenotrophomonas maltophilia, Aeromonas hydrophilia, Escherichia coli, Citrobacter freundii, Salmonella
typhimurium, Salmonella typhi, Salmonella paratyphi, Salmonella enteritidis, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Providencia stuartii, Acinetobacter calcoaceticus, Acinetobacter haemolyticus, Yersinia enterocolitica, Yersinia pestis, Yersinia pseudotuberculosis, Yersinia intermedia, Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus haemolyticus, Haemophilus parahaemolyticus, Haemophilus ducreyi, Pasteurella multocida, Pasteurella haemolytica, Helicobacter pylori, Campylobacter fetus, Campylobacter jejuni, Campylobacter coli, Borrelia burgdorferi, Vibrio cholera, Vibrio parahaemolyticus, Legionella pneumophila, Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Burkholderia cepacia, Francisella tularensis, Kingella и Moraxella.
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