JP6779213B2 - 尿路感染症の治療におけるフィナフロキサシンの使用 - Google Patents
尿路感染症の治療におけるフィナフロキサシンの使用 Download PDFInfo
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- JP6779213B2 JP6779213B2 JP2017535642A JP2017535642A JP6779213B2 JP 6779213 B2 JP6779213 B2 JP 6779213B2 JP 2017535642 A JP2017535642 A JP 2017535642A JP 2017535642 A JP2017535642 A JP 2017535642A JP 6779213 B2 JP6779213 B2 JP 6779213B2
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- JP
- Japan
- Prior art keywords
- finafloxacin
- treatment
- pyelonephritis
- days
- urinary tract
- 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.)
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- FYMHQCNFKNMJAV-HOTGVXAUSA-N finafloxacin Chemical compound C12=C(C#N)C(N3C[C@@H]4OCCN[C@H]4C3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 FYMHQCNFKNMJAV-HOTGVXAUSA-N 0.000 title claims description 73
- 229960002839 finafloxacin Drugs 0.000 title claims description 73
- 238000011282 treatment Methods 0.000 title claims description 68
- 208000019206 urinary tract infection Diseases 0.000 title claims description 60
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 claims description 54
- 239000000203 mixture Substances 0.000 claims description 42
- 206010037596 Pyelonephritis Diseases 0.000 claims description 28
- 229960003405 ciprofloxacin Drugs 0.000 claims description 27
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 20
- 239000007983 Tris buffer Substances 0.000 claims description 16
- 238000009472 formulation Methods 0.000 claims description 15
- 210000002700 urine Anatomy 0.000 claims description 14
- 238000007911 parenteral administration Methods 0.000 claims description 10
- 239000011780 sodium chloride Substances 0.000 claims description 10
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 8
- 239000002552 dosage form Substances 0.000 claims description 3
- 239000013022 formulation composition Substances 0.000 claims 8
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 239000003814 drug Substances 0.000 description 40
- 229940079593 drug Drugs 0.000 description 40
- 230000001225 therapeutic effect Effects 0.000 description 23
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 18
- 244000052769 pathogen Species 0.000 description 17
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 9
- 229940124307 fluoroquinolone Drugs 0.000 description 9
- 238000001990 intravenous administration Methods 0.000 description 9
- 238000002560 therapeutic procedure Methods 0.000 description 9
- 239000003242 anti bacterial agent Substances 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 230000000844 anti-bacterial effect Effects 0.000 description 6
- 230000008901 benefit Effects 0.000 description 6
- 230000003115 biocidal effect Effects 0.000 description 6
- 208000015181 infectious disease Diseases 0.000 description 6
- 238000001802 infusion Methods 0.000 description 6
- 230000002906 microbiologic effect Effects 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 229940088710 antibiotic agent Drugs 0.000 description 5
- 208000024891 symptom Diseases 0.000 description 5
- 230000002485 urinary effect Effects 0.000 description 5
- 206010011409 Cross infection Diseases 0.000 description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 4
- 230000002378 acidificating effect Effects 0.000 description 4
- 230000001580 bacterial effect Effects 0.000 description 4
- 238000011161 development Methods 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 230000037406 food intake Effects 0.000 description 4
- 230000004044 response Effects 0.000 description 4
- 150000003839 salts Chemical class 0.000 description 4
- 230000009471 action Effects 0.000 description 3
- 238000012258 culturing Methods 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 230000001717 pathogenic effect Effects 0.000 description 3
- -1 quinolone carboxylic acids Chemical class 0.000 description 3
- 230000009467 reduction Effects 0.000 description 3
- 238000011160 research Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 229940126585 therapeutic drug Drugs 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 239000003518 caustics Substances 0.000 description 2
- 239000000645 desinfectant Substances 0.000 description 2
- 238000009509 drug development Methods 0.000 description 2
- 230000008029 eradication Effects 0.000 description 2
- 239000002050 international nonproprietary name Substances 0.000 description 2
- 238000011866 long-term treatment Methods 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000003798 microbiological reaction Methods 0.000 description 2
- 230000035772 mutation Effects 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 230000029219 regulation of pH Effects 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010019375 Helicobacter infections Diseases 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-O Htris Chemical compound OCC([NH3+])(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-O 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 208000036209 Intraabdominal Infections Diseases 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 241000122973 Stenotrophomonas maltophilia Species 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000001332 colony forming effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 150000004677 hydrates Chemical class 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000002054 inoculum Substances 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 150000007660 quinolones Chemical class 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 206010040872 skin infection Diseases 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
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
- A61K31/535—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
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
- Engineering & Computer Science (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Dermatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Description
異なるpH値に調節された異なる病原菌の、ブロス1ml当たりのコロニー形成単位が106である一晩接種物を、フィナフロキサシンに暴露した。細菌の増殖は、培養(低温放置)前および培養後1時間で判定した。
非複雑性UTIの患者を経口投与量300mgのフィナフロキサシンまたは250mgのシプロフロキサシンで治療し、尿中のフルオロキノロン感受性病原菌の濃度を、薬剤摂取前、および摂取後2時間、4時間および8時間において求めた(−は103未満の細菌力価)。
複雑性UTIまたは腎盂腎炎を患っている患者について、フィナフロキサシン組成物の薬効をシプロフロキサシン組成物に対して、二重盲検ランダム化臨床試験で比較した。
複雑性UTIまたは腎盂腎炎を患っている患者について、フィナフロキサシン組成物での治療による患者の治療効率を、異なる治療期間について、二重盲検ランダム化臨床試験で評価した。
複雑性UTIまたは腎盂腎炎の患者の尿のpHをモニターし、尿のpHが7未満の患者群の治療開始から3日後の微生物学的治癒率を、フィナフロキサシン組成物およびシプロフロキサシン組成物について比較した。尿のpHは、一般的なpH試験紙を用いて簡単に求めることができる。
Claims (9)
- 1、2、または3日間の治療期間に一日当たりフィナフロキサシン300mgから800mgの投与処方における複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 投与処方が、3日間の治療期間を含む、請求項1に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 経口投与の剤形中に存在する、請求項1または2に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 非経口投与の剤形中に存在する、請求項1または2に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 投与処方が一日当たり800mgのフィナフロキサシンを含む、請求項1から4のいずれか一項に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 尿のpHが7未満の患者に投与される、請求項1から5のいずれか一項に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 製剤組成物が、さらにトリスを溶解度向上剤として0.001Mから0.1Mの濃度で含む、請求項1、2及び4から6のいずれか一項に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 製剤組成物が、1から6g/Lのフィナフロキサシン、7.8g/Lの塩化ナトリウム、及び1.21g/Lのトリスを含む、請求項1、2及び4から7のいずれか一項に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
- 製剤組成物が、3.2g/Lのフィナフロキサシン、7.8g/Lの塩化ナトリウム、及び1.21g/Lのトリスを含む、請求項1、2及び4から8のいずれか一項に記載の複雑性尿路感染症または腎盂腎炎を治療するための、フィナフロキサシンを含む製剤組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102015100068.7 | 2015-01-06 | ||
DE102015100068.7A DE102015100068A1 (de) | 2015-01-06 | 2015-01-06 | Finafloxacin zur verwendung bei der behandlung von harnwegsinfektionen |
PCT/IB2015/058660 WO2016110754A1 (en) | 2015-01-06 | 2015-11-10 | Finafloxacin for use in the treatment of urinary tract infections |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2018500381A JP2018500381A (ja) | 2018-01-11 |
JP6779213B2 true JP6779213B2 (ja) | 2020-11-04 |
Family
ID=54601860
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017535642A Active JP6779213B2 (ja) | 2015-01-06 | 2015-11-10 | 尿路感染症の治療におけるフィナフロキサシンの使用 |
Country Status (6)
Country | Link |
---|---|
US (1) | US10485805B2 (ja) |
EP (1) | EP3242667B1 (ja) |
JP (1) | JP6779213B2 (ja) |
CN (1) | CN107106567A (ja) |
DE (1) | DE102015100068A1 (ja) |
WO (1) | WO2016110754A1 (ja) |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19652239A1 (de) | 1996-12-16 | 1998-06-18 | Bayer Ag | Verwendung von 7-(2-Oxa-5,8-diazabicyclo[4.3.0]non-8-yl)-chinolon- und -naphthyridoncarbonsäure-Derivaten zur Therapie von Helicobacter-pylori-Infektionen und den damit assoziierten gastroduodenalen Erkrankungen |
JP5784012B2 (ja) | 2009-07-02 | 2015-09-24 | アルコン リサーチ, リミテッド | 眼、耳または鼻の感染症を処置するためのフィナフロキサシンを含む組成物および方法 |
US9504691B2 (en) * | 2012-12-06 | 2016-11-29 | Alcon Research, Ltd. | Finafloxacin suspension compositions |
DE102014115951A1 (de) * | 2014-11-03 | 2016-05-04 | Merlion Pharmaceuticals Pte Ltd. | Zusammensetzungen, die Finafloxacin und Tris enthalten |
-
2015
- 2015-01-06 DE DE102015100068.7A patent/DE102015100068A1/de not_active Withdrawn
- 2015-11-10 US US15/541,543 patent/US10485805B2/en active Active
- 2015-11-10 CN CN201580071881.9A patent/CN107106567A/zh active Pending
- 2015-11-10 EP EP15797454.4A patent/EP3242667B1/en active Active
- 2015-11-10 JP JP2017535642A patent/JP6779213B2/ja active Active
- 2015-11-10 WO PCT/IB2015/058660 patent/WO2016110754A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
EP3242667A1 (en) | 2017-11-15 |
US10485805B2 (en) | 2019-11-26 |
EP3242667B1 (en) | 2024-06-05 |
US20170354661A1 (en) | 2017-12-14 |
WO2016110754A1 (en) | 2016-07-14 |
DE102015100068A1 (de) | 2016-07-07 |
CN107106567A (zh) | 2017-08-29 |
JP2018500381A (ja) | 2018-01-11 |
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