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ES2190241T3 - Compuestos farmaceuticos de liberacion rapida de substancias medicamentosas. - Google Patents

Compuestos farmaceuticos de liberacion rapida de substancias medicamentosas.

Info

Publication number
ES2190241T3
ES2190241T3 ES99941418T ES99941418T ES2190241T3 ES 2190241 T3 ES2190241 T3 ES 2190241T3 ES 99941418 T ES99941418 T ES 99941418T ES 99941418 T ES99941418 T ES 99941418T ES 2190241 T3 ES2190241 T3 ES 2190241T3
Authority
ES
Spain
Prior art keywords
composition
powder
active substance
sieve
therapeutically
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
Application number
ES99941418T
Other languages
English (en)
Inventor
Poul Bertelsen
Nils Gjerl V Hansen
Hermann Ruckendorfer
Shigeru Itai
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharma AS
Original Assignee
Nycomed Danmark AS
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 Nycomed Danmark AS filed Critical Nycomed Danmark AS
Application granted granted Critical
Publication of ES2190241T3 publication Critical patent/ES2190241T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/46—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of glucocorticosteroids

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Compuesto farmacéutico de liberación rápida para administración oral, que comprende una substancia terapéutica y/o profilácticamente activa, cuya substancia activa queda definida por una de las características i) o ii): i) la substancia activa tiene una solubilidad máxima de 0, 1 % peso/volumen en ácido clorhídrico 0, 1 N a temperatura ambiente; ii) la substancia activa tiene un valor pKa máximo de 5, 5, y en el que el compuesto farmacéutico de liberación rápida tiene además una de las características iii) o iv): iv) el compuesto farmacéutico de liberación rápida se basa en un material en polvo que comprende la substancia terapéutica y/o profilácticamente activa y que tiene un tamaño de partículas que, cuando el material en polvo es sometido a análisis de cribado, como mínimo, 90 % peso/peso de las partículas atraviesan una criba de 180 µm, estableciendo contacto el material en polvo con un medio acuoso para formar un compuesto en partículas, que tiene un tamaño de partículas tal que, cuando el compuesto en partículas es sometido a análisis de cribado, entonces un mínimo de 50 % peso/peso de las partículas atraviesan una criba de 180 µm; iv) el compuesto farmacéutico de liberación rápida adopta la forma de compuesto en partículas o se basa en un compuesto en partículas, que es obtenido por contacto de un material en polvo que comprende la substancia terapéutica y/o profilácticamente activa con un medio acuoso de manera tal que el tamaño medio de partículas del compuesto es como máximo 100 % superior al tamaño medio de partículas del material en polvo antes de contacto con el medio acuoso, y en el que el compuesto farmacéutico de liberación rápida es tal que la substancia activa recibe el contacto de una substancia alcalina, y en el que el compuesto farmacéutico de liberación rápida, una vez comprobada de acuerdo con el método de disolución I que se ha definido utilizando ácido clorhídrico 0, 07 N como medio de disolución, libera un mínimo de 50 % peso/peso de la substancia activa dentro de los primeros 20 minutos de la prueba.
ES99941418T 1998-09-10 1999-09-10 Compuestos farmaceuticos de liberacion rapida de substancias medicamentosas. Expired - Lifetime ES2190241T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DKPA199801143 1998-09-10

Publications (1)

Publication Number Publication Date
ES2190241T3 true ES2190241T3 (es) 2003-07-16

Family

ID=8101500

Family Applications (1)

Application Number Title Priority Date Filing Date
ES99941418T Expired - Lifetime ES2190241T3 (es) 1998-09-10 1999-09-10 Compuestos farmaceuticos de liberacion rapida de substancias medicamentosas.

Country Status (13)

Country Link
US (1) US6713089B1 (es)
EP (1) EP1109534B1 (es)
JP (2) JP5026635B2 (es)
AT (1) ATE232382T1 (es)
AU (1) AU5504599A (es)
CA (1) CA2343148C (es)
DE (1) DE69905380T2 (es)
DK (1) DK1109534T3 (es)
EA (1) EA004032B1 (es)
ES (1) ES2190241T3 (es)
PT (1) PT1109534E (es)
TR (1) TR200100708T2 (es)
WO (1) WO2000015195A1 (es)

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Also Published As

Publication number Publication date
WO2000015195A1 (en) 2000-03-23
CA2343148C (en) 2005-11-15
US6713089B1 (en) 2004-03-30
EP1109534A1 (en) 2001-06-27
AU5504599A (en) 2000-04-03
JP2012082197A (ja) 2012-04-26
EA004032B1 (ru) 2003-12-25
EA200100331A1 (ru) 2001-08-27
JP2002524492A (ja) 2002-08-06
PT1109534E (pt) 2003-06-30
DE69905380D1 (de) 2003-03-20
DK1109534T3 (da) 2003-06-10
ATE232382T1 (de) 2003-02-15
JP5026635B2 (ja) 2012-09-12
DE69905380T2 (de) 2003-11-27
TR200100708T2 (tr) 2001-07-23
EP1109534B1 (en) 2003-02-12
CA2343148A1 (en) 2000-03-23
JP5622703B2 (ja) 2014-11-12

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