JP5522877B2 - モキシフロキサシン/塩化ナトリウム製剤 - Google Patents
モキシフロキサシン/塩化ナトリウム製剤 Download PDFInfo
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- JP5522877B2 JP5522877B2 JP2001514981A JP2001514981A JP5522877B2 JP 5522877 B2 JP5522877 B2 JP 5522877B2 JP 2001514981 A JP2001514981 A JP 2001514981A JP 2001514981 A JP2001514981 A JP 2001514981A JP 5522877 B2 JP5522877 B2 JP 5522877B2
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- Prior art keywords
- moxifloxacin
- sodium chloride
- formulation
- solution
- aqueous
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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
- A61K9/08—Solutions
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
- C07D471/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
- C07D471/04—Ortho-condensed 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Saccharide Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
3.0]ノン−8−イル)−6−フルオロ−1,4−ジヒドロ−8−メト
キシ−4−オキソ−3−キノロンカルボン酸
本物質は、非常に有効な抗感染薬であり、EP−A−0350733に初めて記述された。しかし、EP−0350733は、非経口投与に適した医薬製剤については記述していなかった。だが、経口的に投与できない集中治療室で患者を治療するには、非経口的に投与できる上記の注入(infusion)用溶液が必要とされる。
比較例1:5%グルコースで等張化した等張モキシフロキサシン製剤、0.2%(w/v)(400mg/200ml)
モキシフロキサシンHCl 0.2%(w/v)*
グルコースモノハイドレート 5.0%(w/v)
注射用水 94.8%(w/v)
*ベタイン型のモキシフロキサシンに換算した量
初めに製剤品位(pharmaceutical quality)のステンレススチール製反応容器に水を仕込み、そこに、塩酸モキシフロキサシンを攪拌しながら溶解する。その有効物質溶液にグルコース(市販品、Fe約380ppm)を添加し、そこで溶解する。その混合液を0.2μm滅菌フィルターで濾過し、200mlづつを点滴ビンに充填し、これを密閉し、オートクレーブ中、121℃で20分間滅菌する。完成溶液は約25ppbの鉄を含有する。
比較例2:
モキシフロキサシン製剤0.4%(w/v)(400mg/100ml)、張性を3%塩化ナトリウムを使って調整
モキシフロキサシンHCl 0.4%(w/v)*
塩化ナトリウム 0.3%(w/v)
注射用水 99.3%(w/v)
*ベタイン型のモキシフロキサシンに換算した量
初めにステンレススチール製反応容器に水を仕込み、そこに、塩酸モキシフロキサシンを攪拌しながら溶解する。その有効物質溶液に塩化ナトリウムを添加し、そこで溶解する。その混合液を0.2μm滅菌フィルターで濾過し、100mlづつを点滴ビンに充填し、これを密閉し、オートクレーブ中、121℃で20分間滅菌する。
実施例1:モキシフロキサシン製剤0.16%(w/v)(400mg/250ml)
モキシフロキサシンHCl 0.16%(w/v)*
塩化ナトリウム 0.8%(w/v)
注射用水 99.04%(w/v)
*ベタイン型のモキシフロキサシンに換算した量
初めにガラス製反応容器に水を仕込み、そこに、塩酸モキシフロキサシンを攪拌しながら溶解する。その有効物質溶液に塩化ナトリウムを添加し、そこで溶解する。塩化第二鉄溶液を混合液に添加する。その混合液を0.2μm滅菌フィルターで濾過し、250mlづつを点滴ビンに充填し、これを密閉し、オートクレーブ中、121℃で20分間滅菌する。
実施例2:モキシフロキサシン製剤0.1%(w/v)(100mg/100ml)
モキシフロキサシンHCl 0.1%(w/v)*
塩化ナトリウム 0.9%(w/v)
注射用水 99.0%(w/v)
浸透圧:313mOsmol/kg
*ベタイン型のモキシフロキサシンに換算した量
初めに製剤用ステンレススチール製反応容器に水を仕込み、そこに、塩酸モキシフロキサシンを攪拌しながら溶解する。その有効物質溶液に塩化ナトリウムを添加し、そこで溶解する。その混合液を0.2μm滅菌フィルターで濾過し、100mlづつを点滴ビンに充填し、これを密閉し、オートクレーブ中、121℃で20分間滅菌する。
実施例3:モキシフロキサシン製剤0.04%(w/v)(40mg/100ml)
モキシフロキサシンHCl 0.04%(w/v)*
塩化ナトリウム 0.9%(w/v)
注射用水 全量を100mlとする
浸透圧:310mOsmol/kg
*ベタイン型のモキシフロキサシンに換算した量
実施例4:モキシフロキサシン製剤0.08%(w/v)(80mg/100ml)
モキシフロキサシンHCl 0.08%(w/v)*
塩化ナトリウム 0.9%(w/v)
注射用水 全量を100mlとする
浸透圧:312mOsmol/kg
*ベタイン型のモキシフロキサシンに換算した量
実施例5:モキシフロキサシン製剤0.2%(w/v)(200mg/100ml)
モキシフロキサシンHCl 0.2%(w/v)*
塩化ナトリウム 0.8%(w/v)
注射用水 全量を100mlとする
浸透圧:283mOsmol/kg
*べタイン型のモキシフロキサシンに換算した量
実施例6:モキシフロキサシン製剤0.3%(w/v)(300mg/100ml)
モキシフロキサシンHCl 0.3%(w/v)*
塩化ナトリウム 0.5%(w/v)
注射用水 全量を100mlとする
浸透圧:186mOsmol/kg
*ベタイン型のモキシフロキサシンに換算した量
実施例7:モキシフロキサシン製剤0.4%(w/v)(400mg/100ml)
モキシフロキサシンHCl 0.4%(w/v)*
塩化ナトリウム 0.4%(w/v)
注射用水 全量を100mlとする
浸透圧:155mOsmol/kg
*ベタイン型のモキシフロキサシンに換算した量
実施例8:点滴用濃縮液2%(w/v)(400mg/20ml)
塩酸モキシフロキサシン 400mg(ベタインとして計算)
注射用水 全量を20mlとする
初めに水を製剤用ステンレススチール製容器に仕込み、塩酸モキシフロキサシンを攪拌しながらそこで溶解する。溶液を0.2μmフィルターで濾過し、20mlづつをガラス製注射ビンに充填し、密閉し、滅菌する。
Claims (5)
- 塩酸モキシフロキサシン0.08%〜0.32%(w/v)(モキシフロキサシン量に換算)と塩化ナトリウム0.4%〜0.9%(w/v)を含んでなる水性製剤。
- 初めに塩酸モキシフロキサシン水溶液を調製し、次いで塩化ナトリウムを添加し、そして溶解することを特徴とする請求項1に記載の水性製剤の調製方法。
- 0.4%(w/v)より多く2.4%(w/v)までの塩酸モキシフロキサシン濃度(モキシフロキサシン量に換算)を有する塩酸モキシフロキサシンの水溶液を塩化ナトリウムを含む水溶液と混合することを特徴とする請求項1に記載の塩酸モキシフロキサシンの水性製剤の調製方法。
- 0.4%(w/v)より多く2.4%(w/v)までの塩酸モキシフロキサシン濃度(モキシフロキサシン量に換算)を有する塩酸モキシフロキサシンの水溶液と塩化ナトリウムを含む水溶液を相互に別々に含んでなる請求項3に記載の方法に使用するための組み合わせ(combination)調製物。
- 請求項1に記載の水性製剤を含んでなる、人または動物における細菌感染症の予防または処置のための薬剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19937116.4 | 1999-08-06 | ||
DE19937116A DE19937116A1 (de) | 1999-08-06 | 1999-08-06 | Moxifloxacin Kochsalzformulierung |
PCT/EP2000/007098 WO2001010465A1 (de) | 1999-08-06 | 2000-07-25 | Moxifloxacin kochsalzformulierung |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2003506416A JP2003506416A (ja) | 2003-02-18 |
JP2003506416A5 JP2003506416A5 (ja) | 2007-09-06 |
JP5522877B2 true JP5522877B2 (ja) | 2014-06-18 |
Family
ID=7917417
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001514981A Expired - Lifetime JP5522877B2 (ja) | 1999-08-06 | 2000-07-25 | モキシフロキサシン/塩化ナトリウム製剤 |
Country Status (40)
Country | Link |
---|---|
US (1) | US6548079B1 (ja) |
EP (1) | EP1206281B1 (ja) |
JP (1) | JP5522877B2 (ja) |
KR (1) | KR100735788B1 (ja) |
CN (1) | CN1246039C (ja) |
AR (1) | AR025001A1 (ja) |
AT (1) | ATE270104T1 (ja) |
AU (1) | AU771058B2 (ja) |
BG (1) | BG65304B1 (ja) |
BR (1) | BRPI0013010B8 (ja) |
CA (1) | CA2378424C (ja) |
CO (1) | CO5190677A1 (ja) |
CU (1) | CU23367A3 (ja) |
CZ (1) | CZ298768B6 (ja) |
DE (2) | DE19937116A1 (ja) |
DK (1) | DK1206281T3 (ja) |
EE (1) | EE04771B1 (ja) |
ES (1) | ES2223549T3 (ja) |
GT (1) | GT200000123A (ja) |
HK (1) | HK1049615B (ja) |
HN (1) | HN2000000115A (ja) |
HR (1) | HRP20020198B1 (ja) |
HU (1) | HU229571B1 (ja) |
IL (2) | IL147553A0 (ja) |
MA (1) | MA25427A1 (ja) |
MX (1) | MXPA02001254A (ja) |
MY (1) | MY125356A (ja) |
NO (1) | NO320743B1 (ja) |
NZ (1) | NZ516969A (ja) |
PE (1) | PE20010400A1 (ja) |
PL (1) | PL198132B1 (ja) |
PT (1) | PT1206281E (ja) |
RU (1) | RU2260429C9 (ja) |
SI (1) | SI1206281T1 (ja) |
SK (1) | SK285650B6 (ja) |
TW (1) | TWI238719B (ja) |
UA (1) | UA72268C2 (ja) |
UY (1) | UY26269A1 (ja) |
WO (1) | WO2001010465A1 (ja) |
ZA (1) | ZA200200215B (ja) |
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DE19937116A1 (de) | 1999-08-06 | 2001-02-08 | Bayer Ag | Moxifloxacin Kochsalzformulierung |
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CN101787022B (zh) * | 2009-10-09 | 2012-08-22 | 浙江医药股份有限公司新昌制药厂 | 一种喹啉羧酸盐酸盐一水合物晶型及其制备方法 |
WO2011086577A2 (en) * | 2010-01-12 | 2011-07-21 | Msn Laboratories Limited | Pharmaceutical composition of moxifloxacin and its pharmaceutically acceptable salts |
CN101836950A (zh) * | 2010-03-12 | 2010-09-22 | 陕西合成药业有限公司 | 一种盐酸莫西沙星葡萄糖注射液及其制备方法和用途 |
CN103919779B (zh) * | 2010-09-10 | 2016-02-10 | 杭州民生药业有限公司 | 一种含有莫西沙星的药物组合物 |
CN102100666B (zh) * | 2011-01-17 | 2012-07-18 | 南京新港医药有限公司 | 一种新的盐酸莫西沙星注射剂 |
CN102093349B (zh) * | 2011-01-17 | 2012-03-07 | 南京新港医药有限公司 | 一种工业化生产盐酸莫西沙星的方法 |
CN102688183B (zh) * | 2011-03-21 | 2016-04-06 | 重庆医药工业研究院有限责任公司 | 一种稳定的盐酸莫西沙星注射剂 |
KR101435244B1 (ko) * | 2011-04-12 | 2014-08-29 | 씨제이헬스케어 주식회사 | 목시플록사신 수성 제형 및 이의 제조방법 |
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CN102600093B (zh) * | 2012-04-11 | 2013-06-05 | 南京优科生物医药有限公司 | 一种莫西沙星片剂及其制备方法 |
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CN103191056B (zh) * | 2013-04-28 | 2014-10-22 | 南京海融医药科技有限公司 | 莫西沙星的口服液体制剂及其制备方法和应用 |
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KR960000223A (ko) | 1994-06-08 | 1996-01-25 | 김정순 | 신규한 피리돈 카르복실산 화합물을 함유한 수용액 및 이의 제조방법 |
PL186795B1 (pl) | 1995-12-21 | 2004-02-27 | Pfizer | Preparat farmaceutyczny zawierający danofloksacynę |
JPH1192375A (ja) * | 1997-09-25 | 1999-04-06 | Morinaga Milk Ind Co Ltd | ニューキノロン系抗菌剤の抗菌性を増強させる抗菌剤 |
AR020661A1 (es) * | 1998-09-30 | 2002-05-22 | Alcon Lab Inc | Una composicion farmaceutica topica oftalmica, otica o nasal y el uso de la misma para la manufactura de un medicamento |
SI1128831T1 (en) * | 1998-11-10 | 2005-04-30 | Bayer Healthcare Ag | Pharmaceutical moxifloxacin preparation |
DE19937115A1 (de) * | 1999-08-06 | 2001-02-08 | Bayer Ag | Wäßrige Arzneimittelformulierung von Moxifloxacin oder Salzen davon |
DE19937116A1 (de) | 1999-08-06 | 2001-02-08 | Bayer Ag | Moxifloxacin Kochsalzformulierung |
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1999
- 1999-08-06 DE DE19937116A patent/DE19937116A1/de not_active Withdrawn
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2000
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