DK2942051T3 - Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor - Google Patents

Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor Download PDF

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Publication number
DK2942051T3
DK2942051T3 DK15169378.5T DK15169378T DK2942051T3 DK 2942051 T3 DK2942051 T3 DK 2942051T3 DK 15169378 T DK15169378 T DK 15169378T DK 2942051 T3 DK2942051 T3 DK 2942051T3
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Prior art keywords
dosage form
weight
pharmaceutical dosage
solid
amino
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DK15169378.5T
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English (en)
Inventor
Jörg Rosenberg
Ulrich Reinhold
Bernd Liepold
Gunther Berndl
Jörg Breitenbach
Laman Alani
Soumojeet Ghosh
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Abbvie Inc
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Publication of DK2942051T3 publication Critical patent/DK2942051T3/da

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    • 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
    • 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
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • 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

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

Claims (10)

1. Fast farmaceutisk doseringsform til anvendelse ved behandling af HIV, hvilken doseringsform omfatter en fast dispersion, som omfatter mindst en HIV-protease-inhibitor i mindst en farmaceutisk acceptabel vandopløselig polymer og mindst et farmaceutisk acceptabelt ikke-ionisk overfladeaktivt middel, hvor den nævnte HIV-protease-inhibitor omfatter lopinavir, og hvor det farmaceutisk acceptable ikke-ioniske overfladeaktive middel omfatter et overfladeaktivt middel, der har en HLB-værdi på fra 4 til 10.
2. Fast farmaceutisk doseringsform til anvendelsen ifølge krav 1, hvor den faste dispersion er en glasagtig opløsning eller fast opløsning af den mindst ene HIV-protease-inhibitor.
3. Fast farmaceutisk doseringsform til anvendelse ifølge krav 1 eller krav 2, hvor det overfladeaktive middel, der har en HLB-værdi på fra 4 til 10, har en HLB-værdi på fra 7 til 9.
4. Fast farmaceutisk doseringsform til anvendelse ifølge krav 1 eller krav 2, hvor det overfladeaktive middel, der har en HLB-værdi på fra 4 til 10, er en sorbitanfedtsyremonoester.
5. Fast farmaceutisk doseringsform til anvendelsen ifølge krav 4, hvor sorbitanfedtsyremonoesteren er valgt blandt sorbitanmonolaurat, sorbitanmonooleat, sorbitanmonopalmitat og sorbitanstearat.
6. Fast farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den farmaceutisk acceptable vandopløselige polymer har en Tg på mindst 50 °C.
7. Fast farmaceutisk doseringsform til anvendelsen ifølge krav 6, hvor den farmaceutisk acceptable vandopløselige polymer har en Tg på fra 80 til 180 °C.
8. Fast farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvor den farmaceutisk acceptable vandopløselige polymer omfatter en homopolymer eller copolymer af N-vinylpyrrolidon.
9. Fast farmaceutisk doseringsform til anvendelse ifølge krav 8, hvor den farmaceutisk acceptable vandopløselige polymer omfatter en copolymer af N-vinylpyrrolidon og vinylacetat.
10. Fast farmaceutisk doseringsform til anvendelse ifølge et hvilket som helst af de foregående krav, hvilken doseringsform indeholder mindst ét additiv der er udvalgt blandt strømningsregulatorer, smøremidler, fyldmidler og sprængmidler.
DK15169378.5T 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor DK2942051T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/650,178 US20050048112A1 (en) 2003-08-28 2003-08-28 Solid pharmaceutical dosage form
EP10181264.2A EP2258345B1 (en) 2003-08-28 2004-08-23 Solid pharmaceutical dosage form comprising an HIV protease inhibitor solid dispersion

Publications (1)

Publication Number Publication Date
DK2942051T3 true DK2942051T3 (da) 2018-05-07

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ID=34217089

Family Applications (5)

Application Number Title Priority Date Filing Date
DK10181264.2T DK2258345T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af en HIV-proteaseinhibitor
DK10181250.1T DK2258344T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af ritonavir og lopinavir
DK04816820.7T DK1663183T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende ritonavir
DK10181268.3T DK2258346T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af en hiv-proteaseinhibitor
DK15169378.5T DK2942051T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform der omfatter en fast dispersion af hiv-protease-inhibitor

Family Applications Before (4)

Application Number Title Priority Date Filing Date
DK10181264.2T DK2258345T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af en HIV-proteaseinhibitor
DK10181250.1T DK2258344T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af ritonavir og lopinavir
DK04816820.7T DK1663183T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende ritonavir
DK10181268.3T DK2258346T3 (da) 2003-08-28 2004-08-23 Fast farmaceutisk doseringsform omfattende en fast dispersion af en hiv-proteaseinhibitor

Country Status (31)

Country Link
US (1) US20050048112A1 (da)
EP (6) EP2258345B1 (da)
JP (6) JP4815348B2 (da)
KR (5) KR20150044031A (da)
CN (5) CN105106104A (da)
AT (1) ATE516017T1 (da)
AU (3) AU2004283087C1 (da)
CA (2) CA2689639C (da)
CR (3) CR8256A (da)
CY (5) CY1111981T1 (da)
DK (5) DK2258345T3 (da)
EA (4) EA033224B1 (da)
EC (1) ECSP066397A (da)
ES (5) ES2608720T3 (da)
HK (4) HK1094766A1 (da)
HR (1) HRP20110555T1 (da)
HU (3) HUE031153T2 (da)
IL (3) IL173939A (da)
ME (2) MEP17608A (da)
MX (2) MXPA06002346A (da)
NO (3) NO330282B1 (da)
NZ (2) NZ545499A (da)
PL (5) PL2258344T3 (da)
PT (5) PT2258346T (da)
RS (2) RS57663B1 (da)
SG (3) SG179401A1 (da)
SI (5) SI1663183T1 (da)
TW (1) TWI342221B (da)
UA (1) UA85564C2 (da)
WO (1) WO2005039551A2 (da)
ZA (3) ZA200801362B (da)

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