CN101091792A - 多剂量红细胞生成素制剂 - Google Patents
多剂量红细胞生成素制剂 Download PDFInfo
- Publication number
- CN101091792A CN101091792A CNA2006100710932A CN200610071093A CN101091792A CN 101091792 A CN101091792 A CN 101091792A CN A2006100710932 A CNA2006100710932 A CN A2006100710932A CN 200610071093 A CN200610071093 A CN 200610071093A CN 101091792 A CN101091792 A CN 101091792A
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- CN
- China
- Prior art keywords
- benzethonium chloride
- phenoxyethanol
- concentration
- bottle
- compositions
- 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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- OXCMYAYHXIHQOA-UHFFFAOYSA-N potassium;[2-butyl-5-chloro-3-[[4-[2-(1,2,4-triaza-3-azanidacyclopenta-1,4-dien-5-yl)phenyl]phenyl]methyl]imidazol-4-yl]methanol Chemical compound [K+].CCCCC1=NC(Cl)=C(CO)N1CC1=CC=C(C=2C(=CC=CC=2)C2=N[N-]N=N2)C=C1 OXCMYAYHXIHQOA-UHFFFAOYSA-N 0.000 title claims abstract description 67
- 239000000203 mixture Substances 0.000 title claims abstract description 58
- 102000003951 Erythropoietin Human genes 0.000 title claims abstract description 12
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- 238000009472 formulation Methods 0.000 title abstract description 14
- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 claims abstract description 95
- 229960001950 benzethonium chloride Drugs 0.000 claims abstract description 95
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 claims abstract description 67
- 229960005323 phenoxyethanol Drugs 0.000 claims abstract description 67
- WRMNZCZEMHIOCP-UHFFFAOYSA-N 2-phenylethanol Chemical compound OCCC1=CC=CC=C1 WRMNZCZEMHIOCP-UHFFFAOYSA-N 0.000 claims abstract description 37
- 238000000034 method Methods 0.000 claims description 39
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 27
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- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical group [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 6
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- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 12
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- 229960004926 chlorobutanol Drugs 0.000 description 6
- SIYLLGKDQZGJHK-UHFFFAOYSA-N dimethyl-(phenylmethyl)-[2-[2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy]ethyl]ammonium Chemical compound C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 SIYLLGKDQZGJHK-UHFFFAOYSA-N 0.000 description 6
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- LDHBWEYLDHLIBQ-UHFFFAOYSA-M iron(3+);oxygen(2-);hydroxide;hydrate Chemical compound O.[OH-].[O-2].[Fe+3] LDHBWEYLDHLIBQ-UHFFFAOYSA-M 0.000 description 1
- JJWLVOIRVHMVIS-UHFFFAOYSA-N isopropylamine Chemical compound CC(C)N JJWLVOIRVHMVIS-UHFFFAOYSA-N 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 201000006370 kidney failure Diseases 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
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- 229940067606 lecithin Drugs 0.000 description 1
- 239000003589 local anesthetic agent Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 description 1
- 229960002510 mandelic acid Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
- POULHZVOKOAJMA-UHFFFAOYSA-N methyl undecanoic acid Natural products CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 description 1
- 238000012009 microbiological test Methods 0.000 description 1
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- 150000007522 mineralic acids Chemical class 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 229910000403 monosodium phosphate Inorganic materials 0.000 description 1
- 235000019799 monosodium phosphate Nutrition 0.000 description 1
- 231100000252 nontoxic Toxicity 0.000 description 1
- 230000003000 nontoxic effect Effects 0.000 description 1
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- 229940107304 oxidized cellulose Drugs 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
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- 229920001155 polypropylene Polymers 0.000 description 1
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- 239000000843 powder Substances 0.000 description 1
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- 229960004919 procaine Drugs 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000001294 propane Substances 0.000 description 1
- 235000013849 propane Nutrition 0.000 description 1
- 230000004845 protein aggregation Effects 0.000 description 1
- 235000004252 protein component Nutrition 0.000 description 1
- 238000001742 protein purification Methods 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
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- 239000012064 sodium phosphate buffer Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
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- 239000003826 tablet Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
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- 229940095064 tartrate Drugs 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/06—Antianaemics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US19821699P | 1999-07-22 | 1999-07-22 | |
| US60/198,216 | 1999-07-22 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN00812138A Division CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101091792A true CN101091792A (zh) | 2007-12-26 |
Family
ID=22732468
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN00812138A Pending CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
| CNA2006100710932A Pending CN101091792A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN00812138A Pending CN1371284A (zh) | 1999-07-22 | 2000-07-21 | 多剂量红细胞生成素制剂 |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US7432360B2 (enExample) |
| EP (1) | EP1200115B9 (enExample) |
| JP (1) | JP2003517462A (enExample) |
| KR (1) | KR100693263B1 (enExample) |
| CN (2) | CN1371284A (enExample) |
| AT (1) | ATE304863T1 (enExample) |
| AU (1) | AU777397B2 (enExample) |
| BR (1) | BR0012667A (enExample) |
| CA (1) | CA2378945C (enExample) |
| CZ (1) | CZ302750B6 (enExample) |
| DE (1) | DE60022759T2 (enExample) |
| DK (1) | DK1200115T3 (enExample) |
| EA (1) | EA006220B1 (enExample) |
| EE (1) | EE200200037A (enExample) |
| ES (1) | ES2248110T3 (enExample) |
| HK (1) | HK1050318A1 (enExample) |
| HR (1) | HRP20020159B1 (enExample) |
| HU (1) | HUP0202246A3 (enExample) |
| IL (2) | IL147755A0 (enExample) |
| NO (1) | NO20020303L (enExample) |
| NZ (1) | NZ516735A (enExample) |
| PL (1) | PL202945B1 (enExample) |
| RS (1) | RS50355B (enExample) |
| WO (1) | WO2001007075A2 (enExample) |
| ZA (1) | ZA200200742B (enExample) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| YU4602A (sh) | 1999-07-22 | 2005-06-10 | Aventis Pharmaceuticals Inc. | Farmaceutske formulacije zaštićene od dejstva mikroorganizama |
| EP1525889A1 (en) | 2000-05-15 | 2005-04-27 | F. Hoffmann-La Roche Ag | Liquid pharmaceutical composition containing an erythropoietin derivative |
| US7148211B2 (en) | 2002-09-18 | 2006-12-12 | Genzyme Corporation | Formulation for lipophilic agents |
| CA2561222A1 (en) * | 2004-03-26 | 2005-10-20 | Janssen Pharmaceutica, N.V. | Combination dosing regimen for erythropoietin |
| US7772182B2 (en) | 2004-08-05 | 2010-08-10 | Alza Corporation | Stable suspension formulations of erythropoietin receptor agonists |
| BRPI0606784B1 (pt) * | 2005-02-03 | 2018-07-31 | Clariant Produkte (Deutschland) Gmbh | Conservantes |
| JP2011116752A (ja) * | 2009-10-29 | 2011-06-16 | Jcr Pharmaceuticals Co Ltd | エリスロポエチン含有水性液剤 |
| KR101805087B1 (ko) * | 2010-09-16 | 2017-12-05 | 주식회사 엘지화학 | 높은 방부력을 제공하는 오일 주사 제형 |
| AU2016341241B9 (en) * | 2015-10-22 | 2021-11-18 | Iltoo Pharma | Pharmaceutical compositions of IL-2 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3489837A (en) * | 1968-07-11 | 1970-01-13 | Leroy J Hyman | Synergistic antiseptic composition consisting of 9-aminoacridine hydrochloride and benzethonium chloride |
| JPS6045849B2 (ja) | 1980-08-25 | 1985-10-12 | 林原 健 | ヒトエリトロポエチンの製造方法 |
| US4703008A (en) | 1983-12-13 | 1987-10-27 | Kiren-Amgen, Inc. | DNA sequences encoding erythropoietin |
| JPS6191131A (ja) * | 1984-10-09 | 1986-05-09 | Chugai Pharmaceut Co Ltd | 医薬品の吸着防止方法および組成物 |
| JPS6197229A (ja) | 1984-10-18 | 1986-05-15 | Chugai Pharmaceut Co Ltd | 安定なエリトロポエチン製剤 |
| JPH0651637B2 (ja) * | 1985-03-28 | 1994-07-06 | エーザイ株式会社 | ペプタイドの吸着防止組成物 |
| US5045529A (en) * | 1989-03-27 | 1991-09-03 | Bionostics, Inc. | Tonometric fluid for blood gas and co-oximetry instruments |
| JP3249147B2 (ja) * | 1990-06-01 | 2002-01-21 | キリン−アムジエン・インコーポレーテツド | 生理活性蛋白含有経口製剤 |
| CA2050425A1 (en) * | 1990-09-03 | 1992-03-04 | Yoshiaki Uda | Pharmaceutical composition and its mucous use |
| DE4126983A1 (de) * | 1991-08-15 | 1993-02-18 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke |
| US5661125A (en) | 1992-08-06 | 1997-08-26 | Amgen, Inc. | Stable and preserved erythropoietin compositions |
| JP2532025B2 (ja) * | 1993-07-23 | 1996-09-11 | 株式会社林原生物化学研究所 | 新リンホカインｉｉｉを有効成分とする抗腫瘍作用を有するリンホカインの活性増強剤 |
| US5968899A (en) * | 1994-06-03 | 1999-10-19 | Tsumura & Co. | Medicinal compositions of peptides with EACA or tranexamic acid for enhanced mucosal absorption |
| WO1997026004A1 (en) * | 1996-01-19 | 1997-07-24 | Eli Lilly And Company | Obesity protein formulations |
| WO1998010785A1 (en) * | 1996-09-13 | 1998-03-19 | Advanced Medicine Research Institute | Ophthalmic compositions of neurotrophic factors, remedies for optic nerve function disorders and method for treating optic nerve function disorders |
| JPH1112193A (ja) * | 1997-06-19 | 1999-01-19 | Sankyo Co Ltd | ヒトカルシトニン含有水溶液製剤 |
| GB9726555D0 (en) * | 1997-12-16 | 1998-02-11 | Smithkline Beecham Plc | Vaccine |
-
2000
- 2000-07-21 ES ES00960177T patent/ES2248110T3/es not_active Expired - Lifetime
- 2000-07-21 AU AU71374/00A patent/AU777397B2/en not_active Ceased
- 2000-07-21 EE EEP200200037A patent/EE200200037A/xx unknown
- 2000-07-21 RS YUP-47/02A patent/RS50355B/sr unknown
- 2000-07-21 HK HK03102133.1A patent/HK1050318A1/zh unknown
- 2000-07-21 CN CN00812138A patent/CN1371284A/zh active Pending
- 2000-07-21 KR KR1020027000944A patent/KR100693263B1/ko not_active Expired - Fee Related
- 2000-07-21 CA CA2378945A patent/CA2378945C/en not_active Expired - Fee Related
- 2000-07-21 CN CNA2006100710932A patent/CN101091792A/zh active Pending
- 2000-07-21 HU HU0202246A patent/HUP0202246A3/hu unknown
- 2000-07-21 DE DE60022759T patent/DE60022759T2/de not_active Expired - Lifetime
- 2000-07-21 EP EP00960177A patent/EP1200115B9/en not_active Expired - Lifetime
- 2000-07-21 JP JP2001511958A patent/JP2003517462A/ja active Pending
- 2000-07-21 WO PCT/US2000/040446 patent/WO2001007075A2/en not_active Ceased
- 2000-07-21 NZ NZ516735A patent/NZ516735A/en not_active IP Right Cessation
- 2000-07-21 HR HR20020159A patent/HRP20020159B1/xx not_active IP Right Cessation
- 2000-07-21 EA EA200200073A patent/EA006220B1/ru not_active IP Right Cessation
- 2000-07-21 CZ CZ20020264A patent/CZ302750B6/cs not_active IP Right Cessation
- 2000-07-21 AT AT00960177T patent/ATE304863T1/de active
- 2000-07-21 BR BR0012667-5A patent/BR0012667A/pt not_active IP Right Cessation
- 2000-07-21 DK DK00960177T patent/DK1200115T3/da active
- 2000-07-21 PL PL353569A patent/PL202945B1/pl not_active IP Right Cessation
- 2000-07-21 IL IL14775500A patent/IL147755A0/xx unknown
-
2002
- 2002-01-21 IL IL147755A patent/IL147755A/en not_active IP Right Cessation
- 2002-01-21 NO NO20020303A patent/NO20020303L/no not_active Application Discontinuation
- 2002-01-28 ZA ZA200200742A patent/ZA200200742B/xx unknown
-
2005
- 2005-06-27 US US11/167,818 patent/US7432360B2/en not_active Expired - Fee Related
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