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HK1022840A1 - Pellets having a core coated with an antifungal and a polymer - Google Patents

Pellets having a core coated with an antifungal and a polymer Download PDF

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Publication number
HK1022840A1
HK1022840A1 HK00101919A HK00101919A HK1022840A1 HK 1022840 A1 HK1022840 A1 HK 1022840A1 HK 00101919 A HK00101919 A HK 00101919A HK 00101919 A HK00101919 A HK 00101919A HK 1022840 A1 HK1022840 A1 HK 1022840A1
Authority
HK
Hong Kong
Prior art keywords
itraconazole
coating
pellets
percent
seal
Prior art date
Application number
HK00101919A
Other languages
German (de)
English (en)
Chinese (zh)
Other versions
HK1022840B (en
Inventor
Petrus Gerebern Vandecruys Roger
Florent Victor De Conde Valentin
Marie Victor Gilis Paul
Peeters Jozef
Original Assignee
Janssen Pharmaceutica N.V.
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 Janssen Pharmaceutica N.V. filed Critical Janssen Pharmaceutica N.V.
Publication of HK1022840A1 publication Critical patent/HK1022840A1/en
Publication of HK1022840B publication Critical patent/HK1022840B/en

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
    • A61K9/14—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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Claims (10)

  1. Comprimé comprenant
    a) un noyau central, rond ou sphérique ;
    b) une pellicule d'un polymère hydrosoluble et d'itraconazole, et
    c) une couche polymère de revêtement étanche,
    caractérisé en ce que le noyau a un diamètre de 250 à 355 µm (45-60 mesh).
  2. Comprimé selon la revendication 1, comprenant en poids basé sur le poids total du comprimé :
    a) de 10 à 25 pourcent de matériel de noyau ;
    b) de 39 à 60 pourcent de polymère hydrosoluble ;
    c) de 26 à 40 pourcent d'itraconazole ; et
    d) de 4 à 7 pourcent de polymère de revêtement étanche.
  3. Comprimé selon la revendication 2, caractérisé en ce que le matériel du noyau est une sphère de sucre de 250 - 355 µm (45-60 mesh) et le polymère hydrosoluble est l'hydroxypropylméthylcellulose.
  4. Comprimé selon la revendication 3, caractérisé en ce que le rapport poids sur poids d'itraconazole : polymère hydrosoluble est de 1:1 à 1:2.
  5. Comprimé selon la revendication 2, caractérisé en ce que le polymère de revêtement étanche est du polyéthylèneglycol.
  6. Comprimé selon la revendication 3, comprenant :
    a) de 16,5 à 19 pourcent de noyaux sucres ;
    b) de 43 à 48 pourcent d'hydroxypropylméthylcellulose 2910 5 mPa.s;
    c) de 29 à 33 pourcent d'itraconazole ; et
    d) de 5 à 6 pourcent de polyéthylèneglycol 20000.
  7. Forme pharmaceutique comprenant une quantité antifongique efficace de comprimés selon l'une quelconque des revendications 1 à 6.
  8. Forme pharmaceutique selon la revendication 7, caractérisée en ce que la forme pharmaceutique est une gélule dure.
  9. Procédé de préparation de comprimés selon l'une quelconque des revendications 1 à 6, caractérisé par
    a) l'enrobage de sphères de sucre de 250 - 355 µm (45-60 mesh) en pulvérisant sur elles une solution d'itraconazole et de polymère hydrosoluble dans un solvant organique constitué de chlorure de méthylène et d'éthanol dans un granulateur à lit fluidisé équipé d'une insertion Wurster (pulvérisation à partir du bas) ;
    b) le séchage des noyaux enrobés résultants ; et
    c) l'enrobage étanche des noyaux secs en pulvérisant sur eux une solution de polymère d'enrobage étanche dans un solvant organique constitué de chlorure de méthylène et d'éthanol dans un granulateur à lit fluidisé équipé d'une insertion Wurster (pulvérisation à partir du bas).
  10. Comprimés enrobés de médicaments, obtenus par un procédé selon la revendication 9.
HK00101919.6A 1997-03-26 1998-03-18 Pellets having a core coated with an antifungal and a polymer HK1022840B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP97200914 1997-03-26
EP97200914 1997-03-26
PCT/EP1998/001773 WO1998042318A1 (fr) 1997-03-26 1998-03-18 Comprimes a noyau enrobe d'un agent antifongique et d'un polymere

Publications (2)

Publication Number Publication Date
HK1022840A1 true HK1022840A1 (en) 2000-08-25
HK1022840B HK1022840B (en) 2003-09-05

Family

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Also Published As

Publication number Publication date
RU2218153C2 (ru) 2003-12-10
CA2269501A1 (fr) 1998-10-01
SI0969821T1 (en) 2003-10-31
IL129575A0 (en) 2000-02-29
TR199900990T2 (xx) 1999-10-21
ES2201485T3 (es) 2004-03-16
AU734248B2 (en) 2001-06-07
CN1206984C (zh) 2005-06-22
AP1227A (en) 2003-11-24
OA11162A (en) 2003-04-16
CA2269501C (fr) 2005-11-08
NO992114D0 (no) 1999-04-30
NO325102B1 (no) 2008-02-04
NO992114L (no) 1999-08-26
PL190566B1 (pl) 2005-12-30
KR20000052971A (ko) 2000-08-25
EP0969821A1 (fr) 2000-01-12
IL129575A (en) 2004-06-20
SK284813B6 (sk) 2005-12-01
HUP0002056A3 (en) 2001-01-29
EE9900453A (et) 2000-04-17
PL335542A1 (en) 2000-04-25
HU224217B1 (hu) 2005-06-28
ID21477A (id) 1999-06-17
JP2001520663A (ja) 2001-10-30
EP0969821B1 (fr) 2003-06-04
SK54499A3 (en) 2000-01-18
CY2384B1 (en) 2004-06-04
KR100520936B1 (ko) 2005-10-17
AP9901516A0 (en) 1999-06-30
WO1998042318A1 (fr) 1998-10-01
NZ335364A (en) 2000-08-25
PT969821E (pt) 2003-10-31
EE03904B1 (et) 2002-12-16
DE69815316T2 (de) 2004-04-29
DE69815316D1 (de) 2003-07-10
CZ295502B6 (cs) 2005-08-17
BG64434B1 (en) 2005-02-28
ATE241969T1 (de) 2003-06-15
CZ139899A3 (cs) 1999-10-13
BR9806174A (pt) 1999-10-19
JP3608800B2 (ja) 2005-01-12
CN1244796A (zh) 2000-02-16
AU7210798A (en) 1998-10-20
BG103356A (en) 2000-03-31
HUP0002056A2 (hu) 2000-12-28
DK0969821T3 (da) 2003-09-15
UA60318C2 (uk) 2003-10-15

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Legal Events

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PE Patent expired

Effective date: 20180317