KR20090024674A - 이온화 방사선에 의해 멸균된 양성자 펌프 억제제를 최종 용기내에 포함하는 비경구 제제 - Google Patents

이온화 방사선에 의해 멸균된 양성자 펌프 억제제를 최종 용기내에 포함하는 비경구 제제 Download PDF

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Publication number
KR20090024674A
KR20090024674A KR1020087027385A KR20087027385A KR20090024674A KR 20090024674 A KR20090024674 A KR 20090024674A KR 1020087027385 A KR1020087027385 A KR 1020087027385A KR 20087027385 A KR20087027385 A KR 20087027385A KR 20090024674 A KR20090024674 A KR 20090024674A
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KR
South Korea
Prior art keywords
formulation
stable
proton pump
ionizing radiation
container
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.)
Withdrawn
Application number
KR1020087027385A
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English (en)
Korean (ko)
Inventor
미카엘 브륄스
조안나 칼슨
Original Assignee
아스트라제네카 아베
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Application filed by 아스트라제네카 아베 filed Critical 아스트라제네카 아베
Publication of KR20090024674A publication Critical patent/KR20090024674A/ko
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08Radiation
    • A61L2/081Gamma radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2103/00Materials or objects being the target of disinfection or sterilisation
    • A61L2103/05Living 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)
KR1020087027385A 2006-05-09 2007-05-07 이온화 방사선에 의해 멸균된 양성자 펌프 억제제를 최종 용기내에 포함하는 비경구 제제 Withdrawn KR20090024674A (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US79905806P 2006-05-09 2006-05-09
US60/799,058 2006-05-09

Publications (1)

Publication Number Publication Date
KR20090024674A true KR20090024674A (ko) 2009-03-09

Family

ID=38667996

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020087027385A Withdrawn KR20090024674A (ko) 2006-05-09 2007-05-07 이온화 방사선에 의해 멸균된 양성자 펌프 억제제를 최종 용기내에 포함하는 비경구 제제

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

Family Cites Families (13)

* 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
PE20021017A1 (es) * 2001-04-03 2002-11-24 Pharmacia Corp Composicion parenteral reconstituible
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
EP1556091A1 (en) * 2002-10-04 2005-07-27 Elan Pharma International Limited Gamma irradiation of solid nanoparticulate active agents
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
JP2005200409A (ja) * 2003-12-17 2005-07-28 Takeda Chem Ind Ltd 注射剤
TW200526268A (en) * 2003-12-17 2005-08-16 Takeda Pharmaceutical Injectable composition

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
JP2009536195A (ja) 2009-10-08
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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PA0105 International application

Patent event date: 20081107

Patent event code: PA01051R01D

Comment text: International Patent Application

PG1501 Laying open of application
PC1203 Withdrawal of no request for examination
WITN Application deemed withdrawn, e.g. because no request for examination was filed or no examination fee was paid