BR0213175A - Forma galênica oral macroparticular para a liberação retardada e controlada de princìpios ativos farmacêuticos - Google Patents

Forma galênica oral macroparticular para a liberação retardada e controlada de princìpios ativos farmacêuticos

Info

Publication number
BR0213175A
BR0213175A BR0213175-7A BR0213175A BR0213175A BR 0213175 A BR0213175 A BR 0213175A BR 0213175 A BR0213175 A BR 0213175A BR 0213175 A BR0213175 A BR 0213175A
Authority
BR
Brazil
Prior art keywords
release
delayed
controlled release
macroparticular
dosage form
Prior art date
Application number
BR0213175-7A
Other languages
English (en)
Other versions
BRPI0213175B8 (pt
BRPI0213175B1 (pt
Inventor
Valerie Legrand
Catherine Castan
Remi Meyrueix
Gerard Soula
Original Assignee
Flamel Tech Sa
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 Flamel Tech Sa filed Critical Flamel Tech Sa
Publication of BR0213175A publication Critical patent/BR0213175A/pt
Publication of BRPI0213175B1 publication Critical patent/BRPI0213175B1/pt
Publication of BRPI0213175B8 publication Critical patent/BRPI0213175B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18Feminine contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Virology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

"FORMA GALêNICA ORAL MACROPARTICULAR PARA A LIBERAçãO RETARDADA E CONTROLADA DE PRINCìPIOS ATIVOS FARMACêUTICOS". A invenção se refere a um sistema microparticular de liberação retardada controlada de princípios ativos (PA), cuja janela de absorção in vivo é essencialmente limitada nas partes altas do trato gastrointestinal , esse sistema sendo destinado a uma administração por via oral. A finalidade da invenção é de fornecer um sistema que a assegura a liberação do PA de forma contínua de forma certa, graças a um duplo mecanismo de "liberação tempo dependente" e "pH dependente". Para atingir essa finalidade, a invenção propós uma forma galênica oral multimicrocapsular concebida de tal modo que sua eficácia terapêutica seja garantida, e na qual a liberação do PA é regida por um duplo mecanismo de acionamento da liberação: "tempo acionador" e "pH acionador". Esse sistema é constituído de microcápsulas (200 a 600 <109>m) que compreendem um núcleo em PA recoberto de uma película de revestimento (máximo 40% em peso), compreendendo um polímero hidrófilo A (EUDRAGIT<32>L) e um composto B hidrófobo (cera vegetal temperatura de fusão = 40-90<198>C), com B/A compreendido entre 0,2 e 1,5. Essas microcápsulas têm um comportamento de dissolução in vitro tal que tem pH 1,4 constante, se observa uma fase de latência compreendida entre 1 e 5 horas seguida de uma liberação do PA e tal que a passagem de pH 1,4 para 6,8 acarreta uma liberação do PA sem tempo de latência in vitro.
BRPI0213175A 2001-10-09 2002-10-09 forma galênica oral macroparticulada para a liberação retardada e controlada de um princípios ativos farmacêuticos e uso de microcápsulas "reservatório" BRPI0213175B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0112999 2001-10-09
FR0112999A FR2830447B1 (fr) 2001-10-09 2001-10-09 Forme galenique orale microparticulaire pour la liberation retardee et controlee de principes actifs pharmaceutiques
PCT/FR2002/003443 WO2003030878A2 (fr) 2001-10-09 2002-10-09 Forme galenique orale microparticulaire

Publications (3)

Publication Number Publication Date
BR0213175A true BR0213175A (pt) 2004-09-14
BRPI0213175B1 BRPI0213175B1 (pt) 2017-06-20
BRPI0213175B8 BRPI0213175B8 (pt) 2021-05-25

Family

ID=8868097

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0213175A BRPI0213175B8 (pt) 2001-10-09 2002-10-09 forma galênica oral macroparticulada para a liberação retardada e controlada de um princípios ativos farmacêuticos e uso de microcápsulas "reservatório"

Country Status (15)

Country Link
US (1) US20050037077A1 (pt)
EP (1) EP1434572B1 (pt)
JP (1) JP4718116B2 (pt)
KR (2) KR20100063825A (pt)
CN (1) CN100341493C (pt)
AU (1) AU2002362712A1 (pt)
BR (1) BRPI0213175B8 (pt)
CA (1) CA2463134C (pt)
ES (1) ES2661723T3 (pt)
FR (1) FR2830447B1 (pt)
HK (1) HK1072898A1 (pt)
IL (2) IL160795A0 (pt)
MX (1) MXPA04003367A (pt)
WO (1) WO2003030878A2 (pt)
ZA (1) ZA200402460B (pt)

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FR2830447A1 (fr) 2003-04-11
FR2830447B1 (fr) 2004-04-16
ZA200402460B (en) 2005-08-31
CN1568181A (zh) 2005-01-19
KR101078636B1 (ko) 2011-11-01
JP2005506336A (ja) 2005-03-03
BRPI0213175B8 (pt) 2021-05-25
AU2002362712A1 (en) 2003-04-22
WO2003030878A2 (fr) 2003-04-17
EP1434572B1 (fr) 2017-12-13
US20050037077A1 (en) 2005-02-17
IL160795A0 (en) 2004-08-31
KR20040073433A (ko) 2004-08-19
KR20100063825A (ko) 2010-06-11
JP4718116B2 (ja) 2011-07-06
MXPA04003367A (es) 2005-01-25
ES2661723T3 (es) 2018-04-03
BRPI0213175B1 (pt) 2017-06-20
EP1434572A2 (fr) 2004-07-07
CN100341493C (zh) 2007-10-10
CA2463134C (fr) 2012-01-03
WO2003030878A3 (fr) 2003-12-04
HK1072898A1 (en) 2005-09-16
CA2463134A1 (fr) 2003-04-17

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