WO2003055483A1 - Solution d'injection de famotidine - Google Patents

Solution d'injection de famotidine Download PDF

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Publication number
WO2003055483A1
WO2003055483A1 PCT/JP2002/013530 JP0213530W WO03055483A1 WO 2003055483 A1 WO2003055483 A1 WO 2003055483A1 JP 0213530 W JP0213530 W JP 0213530W WO 03055483 A1 WO03055483 A1 WO 03055483A1
Authority
WO
WIPO (PCT)
Prior art keywords
famotidine
injection
solution
filled
hydrochloric acid
Prior art date
Application number
PCT/JP2002/013530
Other languages
English (en)
Japanese (ja)
Inventor
Tomoyuki Hojo
Satoko Tabata
Shigeru Suzuki
Original Assignee
Terumo Kabushiki Kaisha
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Terumo Kabushiki Kaisha filed Critical Terumo Kabushiki Kaisha
Priority to JP2003556061A priority Critical patent/JP4374250B2/ja
Priority to AU2002360025A priority patent/AU2002360025A1/en
Publication of WO2003055483A1 publication Critical patent/WO2003055483A1/fr

Links

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
    • A61K47/06—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
    • 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
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • 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
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention does not use a solubilizing agent such as a non-aqueous solvent in consideration of clinical safety, Investigations have been conducted on injections that stably maintain the insoluble, readily soluble famotidine without precipitating them, and based on the finding that the above objective can be achieved by heating the aqueous solution of famotidine at a temperature of 60 ° C or higher. Thus, the present invention has been completed. Further, in the present invention, it has been found that by using hydrochloric acid as an additive for solubilizing famotidine, famotidine in a solution can be stabilized.
  • a solubilizing agent such as a non-aqueous solvent

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)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une solution d'injection de famotidine qui comprend une solution de famotidine aqueuse possédant une histoire thermique comprenant un chauffage à des températures comprises entre 60 °C et 164 °C. Même lorsque cette solution d'injection possède une concentration de famotidine si élevée qu'elle peut être administrée par voie intramusculaire, elle peut être stockée de façon stable à température ambiante pour une longue durée sans nécessiter l'addition d'un agent de solubilisation tel qu'un solvant non aqueux.
PCT/JP2002/013530 2001-12-27 2002-12-25 Solution d'injection de famotidine WO2003055483A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2003556061A JP4374250B2 (ja) 2001-12-27 2002-12-25 ファモチジン注射液
AU2002360025A AU2002360025A1 (en) 2001-12-27 2002-12-25 Famotidine injection

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2001396030 2001-12-27
JP2001/396030 2001-12-27

Publications (1)

Publication Number Publication Date
WO2003055483A1 true WO2003055483A1 (fr) 2003-07-10

Family

ID=19189046

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2002/013530 WO2003055483A1 (fr) 2001-12-27 2002-12-25 Solution d'injection de famotidine

Country Status (3)

Country Link
JP (1) JP4374250B2 (fr)
AU (1) AU2002360025A1 (fr)
WO (1) WO2003055483A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006104069A (ja) * 2004-09-30 2006-04-20 Terumo Corp ヘモグロビン含有リポソームの製造方法および包装体
JP2006136490A (ja) * 2004-11-11 2006-06-01 Terumo Corp 塩酸リトドリン注射液製剤
JP2006271748A (ja) * 2005-03-30 2006-10-12 Taiyo Yakuhin Kogyo Kk 変質しない注射剤包装

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58103312A (ja) * 1981-12-15 1983-06-20 Yamanouchi Pharmaceut Co Ltd 難溶性医薬品の注射剤用水溶液
US4585790A (en) * 1983-05-13 1986-04-29 Glaxo Group Limited Pharmaceutical compositions
JPH0564653A (ja) * 1991-06-26 1993-03-19 Terumo Corp 輸液剤の包装体
WO1993009775A1 (fr) * 1991-11-15 1993-05-27 Baxter International Inc. Formulation de ranitidine premelangee non tamponnee
US5650421A (en) * 1995-03-31 1997-07-22 Baxter International Inc. Premixed famotidine formulation
JPH10314294A (ja) * 1997-05-14 1998-12-02 Toyobo Co Ltd 生体用止血乃至組織接着剤

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS58103312A (ja) * 1981-12-15 1983-06-20 Yamanouchi Pharmaceut Co Ltd 難溶性医薬品の注射剤用水溶液
US4585790A (en) * 1983-05-13 1986-04-29 Glaxo Group Limited Pharmaceutical compositions
JPH0564653A (ja) * 1991-06-26 1993-03-19 Terumo Corp 輸液剤の包装体
WO1993009775A1 (fr) * 1991-11-15 1993-05-27 Baxter International Inc. Formulation de ranitidine premelangee non tamponnee
US5650421A (en) * 1995-03-31 1997-07-22 Baxter International Inc. Premixed famotidine formulation
JPH10314294A (ja) * 1997-05-14 1998-12-02 Toyobo Co Ltd 生体用止血乃至組織接着剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
KIRILMAZ LEVENT ET AL.: "The effect of sterilization conditions on the stability of famotidine hydrochloride as injectable solutions", HACETTEPE UNIVERSITESI ECZACILIK FAKULTESI DERGISI, vol. 14, no. 1, 1994, pages 13 - 21, XP002967021 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006104069A (ja) * 2004-09-30 2006-04-20 Terumo Corp ヘモグロビン含有リポソームの製造方法および包装体
JP2006136490A (ja) * 2004-11-11 2006-06-01 Terumo Corp 塩酸リトドリン注射液製剤
JP4598484B2 (ja) * 2004-11-11 2010-12-15 テルモ株式会社 塩酸リトドリン注射液製剤
JP2006271748A (ja) * 2005-03-30 2006-10-12 Taiyo Yakuhin Kogyo Kk 変質しない注射剤包装

Also Published As

Publication number Publication date
JP4374250B2 (ja) 2009-12-02
JPWO2003055483A1 (ja) 2005-04-28
AU2002360025A1 (en) 2003-07-15

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