JP3381722B2 - 安定化された凍結乾燥型医薬組成物 - Google Patents
安定化された凍結乾燥型医薬組成物Info
- Publication number
- JP3381722B2 JP3381722B2 JP2001507492A JP2001507492A JP3381722B2 JP 3381722 B2 JP3381722 B2 JP 3381722B2 JP 2001507492 A JP2001507492 A JP 2001507492A JP 2001507492 A JP2001507492 A JP 2001507492A JP 3381722 B2 JP3381722 B2 JP 3381722B2
- Authority
- JP
- Japan
- Prior art keywords
- compound
- lactose
- cyclic polypeptide
- pharmaceutically acceptable
- polypeptide compound
- 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.)
- Expired - Lifetime
Links
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- 239000000203 mixture Substances 0.000 claims description 46
- 150000003839 salts Chemical class 0.000 claims description 33
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- 239000008101 lactose Substances 0.000 claims description 31
- 125000004122 cyclic group Chemical group 0.000 claims description 29
- 229920001184 polypeptide Polymers 0.000 claims description 29
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 29
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 29
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 7
- 239000008213 purified water Substances 0.000 claims description 5
- 208000035473 Communicable disease Diseases 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 3
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- 238000002360 preparation method Methods 0.000 claims description 3
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- 238000012360 testing method Methods 0.000 description 15
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 10
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- BSKHPKMHTQYZBB-UHFFFAOYSA-N 2-methylpyridine Chemical class CC1=CC=CC=N1 BSKHPKMHTQYZBB-UHFFFAOYSA-N 0.000 description 1
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- 241000235389 Absidia Species 0.000 description 1
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- 239000004475 Arginine Substances 0.000 description 1
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- XBPCUCUWBYBCDP-UHFFFAOYSA-N Dicyclohexylamine Chemical class C1CCCCC1NC1CCCCC1 XBPCUCUWBYBCDP-UHFFFAOYSA-N 0.000 description 1
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- 241000308443 Exophiala spinifera Species 0.000 description 1
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- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 1
- 241000228402 Histoplasma Species 0.000 description 1
- 201000002563 Histoplasmosis Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 description 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 1
- 241000555676 Malassezia Species 0.000 description 1
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 description 1
- 241001460074 Microsporum distortum Species 0.000 description 1
- 241000041810 Mycetoma Species 0.000 description 1
- 241000186362 Mycobacterium leprae Species 0.000 description 1
- JGFZNNIVVJXRND-UHFFFAOYSA-N N,N-Diisopropylethylamine (DIPEA) Chemical class CCN(C(C)C)C(C)C JGFZNNIVVJXRND-UHFFFAOYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
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- 206010035664 Pneumonia Diseases 0.000 description 1
- 241000235070 Saccharomyces Species 0.000 description 1
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- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 description 1
- 208000007712 Tinea Versicolor Diseases 0.000 description 1
- 206010056131 Tinea versicolour Diseases 0.000 description 1
- 241000223229 Trichophyton rubrum Species 0.000 description 1
- 241000893966 Trichophyton verrucosum Species 0.000 description 1
- 241000223230 Trichosporon Species 0.000 description 1
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical class OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 1
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical class CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 1
- DTQVDTLACAAQTR-UHFFFAOYSA-M Trifluoroacetate Chemical compound [O-]C(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-M 0.000 description 1
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- 230000002378 acidificating effect Effects 0.000 description 1
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- 229910052783 alkali metal Inorganic materials 0.000 description 1
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- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
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- 239000007864 aqueous solution Substances 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 235000009697 arginine Nutrition 0.000 description 1
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- JUHORIMYRDESRB-UHFFFAOYSA-N benzathine Chemical class C=1C=CC=CC=1CNCCNCC1=CC=CC=C1 JUHORIMYRDESRB-UHFFFAOYSA-N 0.000 description 1
- SRSXLGNVWSONIS-UHFFFAOYSA-M benzenesulfonate Chemical compound [O-]S(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-M 0.000 description 1
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- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
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- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A—HUMAN NECESSITIES
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- A61P33/00—Antiparasitic agents
- A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
- A61P33/08—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis for Pneumocystis carinii
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
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- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Communicable Diseases (AREA)
- Gastroenterology & Hepatology (AREA)
- Oncology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Pulmonology (AREA)
- Tropical Medicine & Parasitology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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| JP11-187713 | 1999-07-01 | ||
| JP18771399 | 1999-07-01 | ||
| PCT/JP2000/004381 WO2001002002A1 (en) | 1999-07-01 | 2000-06-29 | Stabilized pharmaceutical composition in lyophilized form |
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| JP2001312701A Division JP4691866B2 (ja) | 1999-07-01 | 2001-10-10 | 安定化された凍結乾燥型医薬組成物 |
Publications (2)
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|---|---|
| JP2003503462A JP2003503462A (ja) | 2003-01-28 |
| JP3381722B2 true JP3381722B2 (ja) | 2003-03-04 |
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| JP2001312701A Expired - Lifetime JP4691866B2 (ja) | 1999-07-01 | 2001-10-10 | 安定化された凍結乾燥型医薬組成物 |
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| JP2001312701A Expired - Lifetime JP4691866B2 (ja) | 1999-07-01 | 2001-10-10 | 安定化された凍結乾燥型医薬組成物 |
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| JP (2) | JP3381722B2 (enExample) |
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| ID (1) | ID29468A (enExample) |
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| NO (1) | NO330353B1 (enExample) |
| NZ (1) | NZ510290A (enExample) |
| OA (1) | OA11601A (enExample) |
| PL (1) | PL200141B1 (enExample) |
| PT (1) | PT1107777E (enExample) |
| RU (1) | RU2251411C2 (enExample) |
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| TW (1) | TWI233805B (enExample) |
| WO (1) | WO2001002002A1 (enExample) |
| ZA (1) | ZA200101589B (enExample) |
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| TWI233805B (en) * | 1999-07-01 | 2005-06-11 | Fujisawa Pharmaceutical Co | Stabilized pharmaceutical composition in lyophilized form as antifungal agent |
| ITMI20021040A1 (it) * | 2002-05-16 | 2003-11-17 | Novuspharma Spa | Composizioni farmaceutiche iniettabili di un derivato antracenedionico ad attivita' antitumorale |
| EP1525884B1 (en) | 2002-07-31 | 2011-10-12 | Senju Pharmaceutical Co., Ltd. | Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
| US8877168B1 (en) | 2002-07-31 | 2014-11-04 | Senju Pharmaceuticals Co., Ltd. | Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
| US7119061B2 (en) * | 2002-11-18 | 2006-10-10 | Vicuron Pharmaceuticals, Inc. | Dalbavancin compositions for treatment of bacterial infections |
| AU2003298662A1 (en) * | 2002-11-18 | 2004-06-15 | Vicuron Pharmaceuticals Inc. | Dalbavancin compositions for treatment of bacterial infections |
| US20060074014A1 (en) * | 2002-11-18 | 2006-04-06 | Vicuron Pharmaceuticals Inc. | Dalbavancin compositions for treatment of bacterial infections |
| CA2558191C (en) * | 2004-03-04 | 2011-01-04 | Eisai R&D Management Co., Ltd. | Composition containing benzamidine derivative and method for stabilizing benzamidine derivative |
| US7514450B2 (en) * | 2004-05-19 | 2009-04-07 | Neurosearch A/S | Azabicyclic aryl derivatives |
| EP2417986A1 (en) * | 2004-11-22 | 2012-02-15 | Anadis Ltd. | Bioactive compositions |
| KR101307999B1 (ko) | 2004-12-01 | 2013-09-12 | 니폰 조키 세야쿠 가부시키가이샤 | 건조물 및 그 제조방법 |
| KR20080028942A (ko) * | 2005-07-20 | 2008-04-02 | 교와 메덱스 가부시키가이샤 | 생체 시료 중의 펩티드의 안정화 방법 |
| CN1962852B (zh) * | 2006-11-27 | 2011-11-09 | 西北农林科技大学 | 红景天多糖在制备抗冻剂中的新用途及其产品和制备方法 |
| CN102614491B (zh) * | 2011-01-31 | 2014-04-16 | 上海天伟生物制药有限公司 | 一种含有棘白菌素类抗真菌剂米卡芬净的药用组合物及其制备方法和用途 |
| CN102614492B (zh) * | 2011-01-31 | 2013-12-11 | 上海天伟生物制药有限公司 | 一种含有棘白菌素类抗真菌剂米卡芬净的液体药用组合物 |
| CN104968348B (zh) * | 2012-05-22 | 2018-04-17 | Paion英国有限公司 | 包含短效苯二氮杂*类化合物的组合物 |
| US20140274994A1 (en) | 2013-03-15 | 2014-09-18 | Cubist Pharmaceuticals, Inc. | Stabilizing ceftolozane |
| US20140274993A1 (en) | 2013-03-15 | 2014-09-18 | Cubist Pharmaceuticals, Inc. | Ceftolozane-tazobactam pharmaceutical compositions |
| US9872906B2 (en) | 2013-03-15 | 2018-01-23 | Merck Sharp & Dohme Corp. | Ceftolozane antibiotic compositions |
| CN103330933B (zh) * | 2013-04-26 | 2015-08-05 | 江苏豪森药业股份有限公司 | 含有米卡芬净或其盐的药物组合物 |
| CN103330932B (zh) * | 2013-04-26 | 2015-12-23 | 江苏豪森药业股份有限公司 | 一种米卡芬净或其盐的药物组合物 |
| ES2978920T3 (es) * | 2013-06-05 | 2024-09-23 | Univ British Columbia | Compuestos antifibrogénicos, métodos y usos de los mismos |
| US10376496B2 (en) | 2013-09-09 | 2019-08-13 | 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 |
| KR101611349B1 (ko) | 2014-04-14 | 2016-04-12 | 신우철 | 안정성이 개선된 밀크씨슬 엑스의 제형 |
| JP7109189B2 (ja) * | 2014-05-29 | 2022-07-29 | シャンハイ テックウェル バイオファーマシューティカル カンパニー リミテッド | シクロペプチド系化合物の組成物およびその製造方法と使用 |
| RU2732129C2 (ru) * | 2014-12-05 | 2020-09-11 | Мейдзи Сейка Фарма Ко., Лтд. | Способ производства кристаллов производного диазабициклооктана и стабильного лиофилизированного препарата |
| DK3240529T3 (da) * | 2014-12-31 | 2022-02-28 | Galenicum Health S L U | Stabile farmaceutiske sammensætninger omfattende micafungin |
| PL3058958T3 (pl) | 2015-02-23 | 2019-02-28 | Selectchemie Ag | Kompozycja anidulafunginy |
| AU2017376960B2 (en) | 2016-12-16 | 2023-12-14 | Baxter Healthcare Sa | Micafungin compositions |
| US11185527B2 (en) | 2017-06-26 | 2021-11-30 | Wayne State University | Methods and compositions relating to steroid hormone receptor-dependent cancers |
| RU2666148C1 (ru) * | 2017-10-05 | 2018-09-06 | Общество с ограниченной ответственностью "Новые Антибиотики" | Способ получения водорастворимой лиофилизированной формы соли бис(2-тио-4,6-диоксо-1,2,3,4,5,6-гексагидропиримидин-5-ил)-(4-нитрофенил)метана |
| EP3485873A1 (en) | 2017-11-17 | 2019-05-22 | Cadila Healthcare Limited | Stable pharmaceutical injectable compositions of micafungin |
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| WO1997039763A1 (en) | 1996-04-19 | 1997-10-30 | Merck & Co., Inc. | Compositions comprising antifungal agent and acetate buffer |
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2000
- 2000-06-28 TW TW089112754A patent/TWI233805B/zh not_active IP Right Cessation
- 2000-06-29 PL PL346297A patent/PL200141B1/pl unknown
- 2000-06-29 WO PCT/JP2000/004381 patent/WO2001002002A1/en not_active Ceased
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- 2000-06-29 JP JP2001507492A patent/JP3381722B2/ja not_active Expired - Lifetime
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- 2000-06-29 NZ NZ510290A patent/NZ510290A/en not_active IP Right Cessation
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- 2000-06-29 AU AU55722/00A patent/AU752265B2/en not_active Expired
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- 2001-02-22 NO NO20010893A patent/NO330353B1/no not_active IP Right Cessation
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO1997039763A1 (en) | 1996-04-19 | 1997-10-30 | Merck & Co., Inc. | Compositions comprising antifungal agent and acetate buffer |
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