NO323810B1 - Flytende preparat og fremgangsmate for fremstilling derav. - Google Patents
Flytende preparat og fremgangsmate for fremstilling derav. Download PDFInfo
- Publication number
- NO323810B1 NO323810B1 NO20025081A NO20025081A NO323810B1 NO 323810 B1 NO323810 B1 NO 323810B1 NO 20025081 A NO20025081 A NO 20025081A NO 20025081 A NO20025081 A NO 20025081A NO 323810 B1 NO323810 B1 NO 323810B1
- Authority
- NO
- Norway
- Prior art keywords
- liquid preparation
- sodium chloride
- sitafloxacin
- stated
- aqueous solution
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 71
- 239000007788 liquid Substances 0.000 title claims abstract description 56
- 238000000034 method Methods 0.000 title claims description 21
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 121
- MPORYQCGWFQFLA-ONPDANIMSA-N 7-[(7s)-7-amino-5-azaspiro[2.4]heptan-5-yl]-8-chloro-6-fluoro-1-[(1r,2s)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid;trihydrate Chemical compound O.O.O.C([C@H]1N)N(C=2C(=C3C(C(C(C(O)=O)=CN3[C@H]3[C@H](C3)F)=O)=CC=2F)Cl)CC11CC1.C([C@H]1N)N(C=2C(=C3C(C(C(C(O)=O)=CN3[C@H]3[C@H](C3)F)=O)=CC=2F)Cl)CC11CC1 MPORYQCGWFQFLA-ONPDANIMSA-N 0.000 claims abstract description 61
- 239000011780 sodium chloride Substances 0.000 claims abstract description 60
- 229960003177 sitafloxacin Drugs 0.000 claims abstract description 59
- 239000007864 aqueous solution Substances 0.000 claims abstract description 36
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 36
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 28
- 238000004519 manufacturing process Methods 0.000 claims description 15
- 230000002378 acidificating effect Effects 0.000 claims description 7
- LBLYYCQCTBFVLH-UHFFFAOYSA-M 2-methylbenzenesulfonate Chemical compound CC1=CC=CC=C1S([O-])(=O)=O LBLYYCQCTBFVLH-UHFFFAOYSA-M 0.000 claims description 3
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims description 3
- 229910002651 NO3 Inorganic materials 0.000 claims description 3
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 claims description 3
- SRSXLGNVWSONIS-UHFFFAOYSA-M benzenesulfonate Chemical compound [O-]S(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-M 0.000 claims description 3
- 229940077388 benzenesulfonate Drugs 0.000 claims description 3
- 239000000243 solution Substances 0.000 description 23
- 230000000694 effects Effects 0.000 description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- 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 description 10
- 229960003376 levofloxacin Drugs 0.000 description 10
- 239000000126 substance Substances 0.000 description 9
- 239000004480 active ingredient Substances 0.000 description 7
- 230000006641 stabilisation Effects 0.000 description 7
- 238000011105 stabilization Methods 0.000 description 7
- 239000012086 standard solution Substances 0.000 description 7
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
- 239000002253 acid Substances 0.000 description 6
- 150000003839 salts Chemical class 0.000 description 6
- 230000005540 biological transmission Effects 0.000 description 5
- 230000001954 sterilising effect Effects 0.000 description 5
- 238000004659 sterilization and disinfection Methods 0.000 description 5
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 4
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 230000014759 maintenance of location Effects 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 230000009467 reduction Effects 0.000 description 4
- 229960002920 sorbitol Drugs 0.000 description 4
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 230000000845 anti-microbial effect Effects 0.000 description 3
- 239000004599 antimicrobial Substances 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 239000012085 test solution Substances 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 2
- 238000004587 chromatography analysis Methods 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000002050 international nonproprietary name Substances 0.000 description 2
- 238000004811 liquid chromatography Methods 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000008363 phosphate buffer Substances 0.000 description 2
- 238000004445 quantitative analysis Methods 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 208000035473 Communicable disease Diseases 0.000 description 1
- PNUZDKCDAWUEGK-CYZMBNFOSA-N Sitafloxacin Chemical compound C([C@H]1N)N(C=2C(=C3C(C(C(C(O)=O)=CN3[C@H]3[C@H](C3)F)=O)=CC=2F)Cl)CC11CC1 PNUZDKCDAWUEGK-CYZMBNFOSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000003929 acidic solution Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000003139 buffering effect Effects 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- 229940043351 ethyl-p-hydroxybenzoate Drugs 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000007306 functionalization reaction Methods 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 150000004677 hydrates Chemical class 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- LISFMEBWQUVKPJ-UHFFFAOYSA-N quinolin-2-ol Chemical compound C1=CC=C2NC(=O)C=CC2=C1 LISFMEBWQUVKPJ-UHFFFAOYSA-N 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000007910 systemic administration Methods 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 238000011200 topical administration Methods 0.000 description 1
Classifications
-
- 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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61P31/04—Antibacterial agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000127622 | 2000-04-24 | ||
| JP2000149812 | 2000-05-17 | ||
| PCT/JP2001/003457 WO2001080858A1 (fr) | 2000-04-24 | 2001-04-23 | Preparation liquide stable |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO20025081D0 NO20025081D0 (no) | 2002-10-22 |
| NO20025081L NO20025081L (no) | 2002-12-23 |
| NO323810B1 true NO323810B1 (no) | 2007-07-09 |
Family
ID=26590975
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO20025081A NO323810B1 (no) | 2000-04-24 | 2002-10-22 | Flytende preparat og fremgangsmate for fremstilling derav. |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US7304075B2 (ja) |
| EP (1) | EP1277471B1 (ja) |
| JP (1) | JP5027975B2 (ja) |
| KR (1) | KR100858228B1 (ja) |
| CN (1) | CN1326524C (ja) |
| AR (1) | AR028028A1 (ja) |
| AT (1) | ATE396729T1 (ja) |
| AU (1) | AU2001248833A1 (ja) |
| BR (1) | BR0110290A (ja) |
| CA (1) | CA2406849C (ja) |
| DE (1) | DE60134221D1 (ja) |
| DK (1) | DK1277471T3 (ja) |
| ES (1) | ES2305065T3 (ja) |
| HK (1) | HK1050326A1 (ja) |
| MX (1) | MXPA02010497A (ja) |
| NO (1) | NO323810B1 (ja) |
| PT (1) | PT1277471E (ja) |
| RU (1) | RU2295342C2 (ja) |
| TW (1) | TWI280131B (ja) |
| WO (1) | WO2001080858A1 (ja) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004011001A1 (ja) | 2002-07-31 | 2004-02-05 | Senju Pharmaceutical Co., Ltd. | 水性液剤および光安定化された水性液剤 |
| US8877168B1 (en) | 2002-07-31 | 2014-11-04 | Senju Pharmaceuticals Co., Ltd. | Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
| JP2006151808A (ja) * | 2002-12-24 | 2006-06-15 | Dai Ichi Seiyaku Co Ltd | 抗菌性水性製剤 |
| EP2055304A1 (en) | 2006-08-25 | 2009-05-06 | Astellas Pharma Inc. | Stabilized pharmaceutical composition |
| JP5258331B2 (ja) * | 2008-03-03 | 2013-08-07 | ロート製薬株式会社 | 光安定性が改善されたニューキノロン系抗菌剤含有医薬組成物 |
| WO2010146478A1 (en) * | 2009-05-08 | 2010-12-23 | Ranbaxy Laboratories Limited | Parenteral composition comprising a fluoroquinolone compound and a nitroimidazole compound |
| CN101690712B (zh) * | 2009-08-25 | 2011-06-15 | 武汉武药科技有限公司 | 一种西他沙星滴眼剂及其制备方法 |
| CN103087042B (zh) * | 2012-03-09 | 2015-02-18 | 南京优科生物医药有限公司 | 西他沙星的盐及制药用途 |
| NZ703528A (en) * | 2012-06-27 | 2016-08-26 | Takeda Pharmaceutical | Liquid preparations of amines and organic acids stabilized by salts |
| US9320740B2 (en) | 2013-03-15 | 2016-04-26 | Merck Sharp & Dohme Corp. | Ceftolozane-tazobactam pharmaceutical compositions |
| US9872906B2 (en) | 2013-03-15 | 2018-01-23 | Merck Sharp & Dohme Corp. | Ceftolozane antibiotic compositions |
| MX2020004205A (es) | 2013-03-15 | 2021-11-16 | Merck Sharp & Dohme Llc | Composiciones antibioticas de ceftolozano. |
| AU2014233637A1 (en) | 2013-09-09 | 2015-03-26 | Merck Sharp & Dohme Corp. | Treating infections with ceftolozane/tazobactam in subjects having impaired renal function |
| US8906898B1 (en) | 2013-09-27 | 2014-12-09 | Calixa Therapeutics, Inc. | Solid forms of ceftolozane |
| CN103622973B (zh) * | 2013-12-02 | 2016-05-11 | 广东恒诚制药有限公司 | 一种复方醋酸曲安奈德溶液的制备方法 |
| AT524927A1 (de) * | 2021-04-07 | 2022-10-15 | Engel Austria Gmbh | Plastifiziereinheit für eine Formgebungsmaschine und Verfahren zum Betreiben einer solchen |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3537761A1 (de) | 1985-10-24 | 1987-04-30 | Bayer Ag | Infusionsloesungen der 1-cyclopropyl-6-fluor-1,4-dihydro-4-oxo-7- (1-piperazinyl)-chinolin-3-carbonsaeure |
| IL90062A (en) * | 1988-04-27 | 1994-10-07 | Daiichi Seiyaku Co | History of pyridonecarboxylic acid, their preparation and pharmaceutical preparations containing them |
| CA2053926A1 (en) | 1989-04-28 | 1990-10-29 | Genkichi Ohta | Anti-hiv agent |
| RU2044544C1 (ru) | 1989-04-28 | 1995-09-27 | Дайити Фармасьютикал Ко., Лтд | Композиция против вируса иммунодефицита человека |
-
2001
- 2001-04-23 CN CNB018116965A patent/CN1326524C/zh not_active Expired - Fee Related
- 2001-04-23 AU AU2001248833A patent/AU2001248833A1/en not_active Abandoned
- 2001-04-23 DE DE60134221T patent/DE60134221D1/de not_active Expired - Fee Related
- 2001-04-23 CA CA002406849A patent/CA2406849C/en not_active Expired - Fee Related
- 2001-04-23 KR KR1020027014222A patent/KR100858228B1/ko not_active IP Right Cessation
- 2001-04-23 RU RU2002128631/15A patent/RU2295342C2/ru active
- 2001-04-23 JP JP2001577957A patent/JP5027975B2/ja not_active Expired - Lifetime
- 2001-04-23 EP EP01922003A patent/EP1277471B1/en not_active Expired - Lifetime
- 2001-04-23 BR BR0110290-7A patent/BR0110290A/pt not_active Application Discontinuation
- 2001-04-23 MX MXPA02010497A patent/MXPA02010497A/es active IP Right Grant
- 2001-04-23 DK DK01922003T patent/DK1277471T3/da active
- 2001-04-23 US US10/258,447 patent/US7304075B2/en not_active Expired - Fee Related
- 2001-04-23 PT PT01922003T patent/PT1277471E/pt unknown
- 2001-04-23 AT AT01922003T patent/ATE396729T1/de not_active IP Right Cessation
- 2001-04-23 WO PCT/JP2001/003457 patent/WO2001080858A1/ja active IP Right Grant
- 2001-04-23 ES ES01922003T patent/ES2305065T3/es not_active Expired - Lifetime
- 2001-04-24 TW TW090109750A patent/TWI280131B/zh not_active IP Right Cessation
- 2001-04-24 AR ARP010101885A patent/AR028028A1/es unknown
-
2002
- 2002-10-22 NO NO20025081A patent/NO323810B1/no not_active IP Right Cessation
-
2003
- 2003-04-09 HK HK03102562A patent/HK1050326A1/xx not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| AR028028A1 (es) | 2003-04-23 |
| HK1050326A1 (en) | 2003-06-20 |
| BR0110290A (pt) | 2003-02-18 |
| DE60134221D1 (de) | 2008-07-10 |
| NO20025081L (no) | 2002-12-23 |
| CN1326524C (zh) | 2007-07-18 |
| KR100858228B1 (ko) | 2008-09-12 |
| KR20020089523A (ko) | 2002-11-29 |
| US7304075B2 (en) | 2007-12-04 |
| CA2406849A1 (en) | 2002-10-21 |
| CA2406849C (en) | 2007-10-23 |
| PT1277471E (pt) | 2008-08-26 |
| NO20025081D0 (no) | 2002-10-22 |
| CN1438888A (zh) | 2003-08-27 |
| WO2001080858A1 (fr) | 2001-11-01 |
| RU2002128631A (ru) | 2004-03-27 |
| US20030139436A1 (en) | 2003-07-24 |
| ES2305065T3 (es) | 2008-11-01 |
| ATE396729T1 (de) | 2008-06-15 |
| EP1277471A1 (en) | 2003-01-22 |
| TWI280131B (en) | 2007-05-01 |
| AU2001248833A1 (en) | 2001-11-07 |
| DK1277471T3 (da) | 2008-08-11 |
| RU2295342C2 (ru) | 2007-03-20 |
| EP1277471A4 (en) | 2006-04-12 |
| JP5027975B2 (ja) | 2012-09-19 |
| MXPA02010497A (es) | 2003-05-14 |
| EP1277471B1 (en) | 2008-05-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |