JP2009536195A - 最終容器中で電離放射線により滅菌されるプロトンポンプ阻害剤を含む非経口製剤 - Google Patents

最終容器中で電離放射線により滅菌されるプロトンポンプ阻害剤を含む非経口製剤 Download PDF

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Publication number
JP2009536195A
JP2009536195A JP2009509484A JP2009509484A JP2009536195A JP 2009536195 A JP2009536195 A JP 2009536195A JP 2009509484 A JP2009509484 A JP 2009509484A JP 2009509484 A JP2009509484 A JP 2009509484A JP 2009536195 A JP2009536195 A JP 2009536195A
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JP
Japan
Prior art keywords
formulation
proton pump
ionizing radiation
container
sterilized
Prior art date
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Pending
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JP2009509484A
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English (en)
Japanese (ja)
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JP2009536195A5 (https=
Inventor
ミカエル・ブリュールス
ヨハンナ・カールソン
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AstraZeneca AB
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AstraZeneca AB
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Publication of JP2009536195A publication Critical patent/JP2009536195A/ja
Publication of JP2009536195A5 publication Critical patent/JP2009536195A5/ja
Pending legal-status Critical Current

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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
    • A61K9/0012—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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2103/00—Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05—Living organisms or biological materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2009509484A 2006-05-09 2007-05-07 最終容器中で電離放射線により滅菌されるプロトンポンプ阻害剤を含む非経口製剤 Pending JP2009536195A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US79905806P 2006-05-09 2006-05-09
PCT/SE2007/000440 WO2007129961A1 (en) 2006-05-09 2007-05-07 Parenteral formulation comprising proton pump inhibitor sterilized in its final container by ionizing radiation

Publications (2)

Publication Number Publication Date
JP2009536195A true JP2009536195A (ja) 2009-10-08
JP2009536195A5 JP2009536195A5 (https=) 2010-06-17

Family

ID=38667996

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2009509484A Pending JP2009536195A (ja) 2006-05-09 2007-05-07 最終容器中で電離放射線により滅菌されるプロトンポンプ阻害剤を含む非経口製剤

Country Status (13)

Country Link
US (1) US20090111856A1 (https=)
EP (1) EP2018151A4 (https=)
JP (1) JP2009536195A (https=)
KR (1) KR20090024674A (https=)
CN (1) CN101442985A (https=)
AU (1) AU2007248949B2 (https=)
BR (1) BRPI0711048A2 (https=)
CA (1) CA2649946A1 (https=)
MX (1) MX2008014283A (https=)
NO (1) NO20084914L (https=)
NZ (1) NZ572007A (https=)
WO (1) WO2007129961A1 (https=)
ZA (1) ZA200808824B (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10953115B2 (en) 2012-05-09 2021-03-23 Icrom S.R.L. Production of sterile active pharmaceutical ingredients
GB2513172A (en) * 2013-04-18 2014-10-22 Nupharm Lab Ltd Liquid dosage form and delivery system
CN103698430B (zh) * 2013-12-24 2015-01-21 江苏正大丰海制药有限公司 一种埃索美拉唑钠和注射用埃索美拉唑钠中杂质含量检测方法
CN105272965A (zh) * 2014-07-03 2016-01-27 上海汇伦生命科技有限公司 一种埃索美拉唑钠的纯化方法
GB201505347D0 (en) * 2015-03-27 2015-05-13 Salupont Consulting Ltd Sterilisation of s-nitrosothiols
US11793748B1 (en) * 2019-04-05 2023-10-24 Good Health, Llc Pharmaceutical compositions of aspirin for parenteral administration
US11666548B2 (en) * 2020-06-05 2023-06-06 Baxter International Inc. Parenteral nutrition formulation

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004525949A (ja) * 2001-04-03 2004-08-26 ファルマシア・コーポレーション Ｃｏｘ−２阻害剤を含む再構成可能な非経口組成物
JP2005200409A (ja) * 2003-12-17 2005-07-28 Takeda Chem Ind Ltd 注射剤
JP2006501936A (ja) * 2002-10-04 2006-01-19 エラン ファーマ インターナショナル，リミティド 固体ナノ粒子活性薬剤のガンマ線照射

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL75400A (en) * 1984-06-16 1988-10-31 Byk Gulden Lomberg Chem Fab Dialkoxypyridine methyl(sulfinyl or sulfonyl)benzimidazoles,processes for the preparation thereof and pharmaceutical compositions containing the same
US4678809A (en) * 1985-02-01 1987-07-07 Michael Phillips Injectable fomulations of disulfiram for the treatment of alcoholism
DE4438360C2 (de) * 1994-10-27 1999-05-20 Schott Glas Vorfüllbare partikelarme, sterile Einmalspritze für die Injektion von Präparaten und Verfahren zu ihrer Herstellung
IL133105A (en) * 1997-06-04 2004-09-27 Debio Rech Pharma Sa Implants for controlled release of pharmaceutically active principles and method for making same
SE9903831D0 (sv) * 1999-10-22 1999-10-22 Astra Ab Formulation of substituted benzimidazoles
WO2003077916A1 (en) * 2002-03-15 2003-09-25 Altana Pharma Ag Use of proton pump inhibitors for the treatment of noncardiac chest pain
DE60304726T2 (de) * 2002-07-19 2007-08-09 Winston Pharmaceuticals Llc, Newport Beach Benzimidazolderivative und ihre verwendung als prodrugs für protonenpumpenhemmer
CN1703198A (zh) * 2002-10-25 2005-11-30 辉瑞产品公司 呈混悬剂形式的芳基杂环活性物质的贮库制剂
ATE466579T1 (de) * 2003-11-05 2010-05-15 Lyka Labs Ltd Verfahren zur herstellung von benzimidazolen
TW200526268A (en) * 2003-12-17 2005-08-16 Takeda Pharmaceutical Injectable composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004525949A (ja) * 2001-04-03 2004-08-26 ファルマシア・コーポレーション Ｃｏｘ−２阻害剤を含む再構成可能な非経口組成物
JP2006501936A (ja) * 2002-10-04 2006-01-19 エラン ファーマ インターナショナル，リミティド 固体ナノ粒子活性薬剤のガンマ線照射
JP2005200409A (ja) * 2003-12-17 2005-07-28 Takeda Chem Ind Ltd 注射剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JPN6012034191; Ｒｅｉｄ　ＢＤ．: 'Ｇａｍｍａ　ｐｒｏｃｅｓｓｉｎｇ　ｔｅｃｈｎｏｌｏｇｙ：　ａｎ　ａｌｔｅｒｎａｔｉｖｅ　ｔｅｃｈｎｏｌｏｇｙ　ｆｏｒ　ｔｅｒｍｉｎａｌ　ｓｔｅｒｉｌｉｚａｔｉｏｎ　ｏｆ　ｐａｒｅｎｔｅｒａｌｓ．' ＰＤＡ　Ｊ　Ｐｈａｒｍ　Ｓｃｉ　Ｔｅｃｈｎｏｌ． Ｖｏｌ．４９　Ｎｏ．２, 199504, ｐｐ．８３-８９ *

Also Published As

Publication number Publication date
EP2018151A4 (en) 2012-07-18
US20090111856A1 (en) 2009-04-30
CN101442985A (zh) 2009-05-27
MX2008014283A (es) 2008-11-18
NZ572007A (en) 2010-12-24
KR20090024674A (ko) 2009-03-09
BRPI0711048A2 (pt) 2011-08-23
ZA200808824B (en) 2009-11-25
EP2018151A1 (en) 2009-01-28
NO20084914L (no) 2008-12-10
WO2007129961A1 (en) 2007-11-15
AU2007248949B2 (en) 2010-04-08
CA2649946A1 (en) 2007-11-15
AU2007248949A1 (en) 2007-11-15

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