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ES2165869T3 - Sistema de liberacion de farmaco en forma de particulas pulsatiles. - Google Patents

Sistema de liberacion de farmaco en forma de particulas pulsatiles.

Info

Publication number
ES2165869T3
ES2165869T3 ES94900544T ES94900544T ES2165869T3 ES 2165869 T3 ES2165869 T3 ES 2165869T3 ES 94900544 T ES94900544 T ES 94900544T ES 94900544 T ES94900544 T ES 94900544T ES 2165869 T3 ES2165869 T3 ES 2165869T3
Authority
ES
Spain
Prior art keywords
water
coating
pellets
pct
core
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
ES94900544T
Other languages
English (en)
Inventor
Chih-Ming Chen
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.)
Andrx Pharmaceuticals LLC
Original Assignee
Andrx Pharmaceuticals LLC
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 Andrx Pharmaceuticals LLC filed Critical Andrx Pharmaceuticals LLC
Application granted granted Critical
Publication of ES2165869T3 publication Critical patent/ES2165869T3/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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

FORMA DE DOSIS DE UNIDAD PARA DISTRIBUIR FARMACOS EN EL CUERPO EN UNA SERIE SECUENCIAL. FENOMENOS DE LIBERACION PULSATILES EMPLEAN EQUIPO FARMACEUTICO CONVENCIONAL Y PROCESOS PARA ECONOMIA, LIBERACION Y BIODISPONIBILIDAD OPTIMOS. EL SISTEMA PUEDE USARSE CON FARMACOS QUE NO PUEDEN SER LIBERADOS A TRAVES DE UN REVESTIMIENTO POROSO, COMO POR EJEMPLO FARMACOS INSOLUBLES EN AGUA. SE PROPORCIONA UNA PLURALIDAD DE POBLACIONES DE COMPRIMIDOS DENTRO DE UNA FORMA DE DOSIS DE UNIDAD COMO POR EJEMPLO UNA CAPSULA (8) O PASTILLA. LOS COMPRIMIDOS ESTAN COMPUESTOS DE UN NUCLEO QUE CONTIENE EL FARMACO (3) Y UN AGENTE DE HINCHAMIENTO (4) QUE SE EXPANDE EN VOLUMEN CUANDO SE EXPONE AL AGUA. EL NUCLEO ESTA ENCERRADO DENTRO DE UNA MEMBRANA O REVESTIMIENTO QUE ES PERMEABLE AL AGUA. LA MEMBRANA ESTA COMPUESTA DE UNA PELICULA INSOLUBLE AL AGUA Y PERMEABLE QUE FORMA UN POLIMERO (11) Y UN AGENTE REDUCTOR DE LA PERMEABILIDAD (14). CUANDO LA DOSIS DE UNIDAD LIBERA LOS COMPRIMIDOS DENTRO DEL TRACTO DIGESTIVO, EL AGUA SEDISPERSA A TRAVES DEL REVESTIMIENTO Y DENTRO DEL NUCLEO. YA QUE EL AGUA ES TOMADA POR EL AGENTE DE HINCHAMIENTO, EL NUCLEO SE EXPANDE, EJERCIENDO UNA FUERZA SOBRE EL REVESTIMIENTO HASTA QUE ESTE ESTALLA, LIBERANDO EL FARMACO. EL AGENTE REDUCTOR DE PERMEABILIDAD REDUCE EL RITMO AL QUE EL AGUA ALCANZA EL AGENTE DE HINCHAMIENTO, RETARDANDO DE ESTE MODO EL TIEMPO DE LIBERACION. EL POLIMERO SOLUBLE EN AGUA SE DISUELVE, DEBILITANDO AL REVESTIMIENTO DE MODO QUE ESTE ESTALLA PRONTO. A TRAVES DE LA VARIACION DE LAS PROPORCIONES DE LOS TRES INGREDIENTES DE REVESTIMIENTO Y/O EL ESPESOR DEL REVESTIMIENTO DE UNA POBLACION DE COMPRIMIDOS A OTRA, EL TIEMPO DE LIBERACION DE LOS COMPRIMIDOS PUEDE SER CONTROLADO DE FORMA MUY EFECTIVA.
ES94900544T 1992-11-27 1993-11-02 Sistema de liberacion de farmaco en forma de particulas pulsatiles. Expired - Lifetime ES2165869T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/982,761 US5260069A (en) 1992-11-27 1992-11-27 Pulsatile particles drug delivery system
PCT/US1993/010643 WO1994012160A1 (en) 1992-11-27 1993-11-02 Pulsatile particles drug delivery system

Publications (1)

Publication Number Publication Date
ES2165869T3 true ES2165869T3 (es) 2002-04-01

Family

ID=25529482

Family Applications (1)

Application Number Title Priority Date Filing Date
ES94900544T Expired - Lifetime ES2165869T3 (es) 1992-11-27 1993-11-02 Sistema de liberacion de farmaco en forma de particulas pulsatiles.

Country Status (10)

Country Link
US (2) US5260069A (es)
EP (1) EP0670718B1 (es)
JP (1) JPH08506802A (es)
AT (1) ATE206613T1 (es)
AU (1) AU680642B2 (es)
CA (1) CA2149152C (es)
DE (1) DE69330910T2 (es)
ES (1) ES2165869T3 (es)
NZ (1) NZ258012A (es)
WO (1) WO1994012160A1 (es)

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EP0670718B1 (en) 2001-10-10
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