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DK2299984T3 - Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf - Google Patents

Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf Download PDF

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Publication number
DK2299984T3
DK2299984T3 DK09746975.3T DK09746975T DK2299984T3 DK 2299984 T3 DK2299984 T3 DK 2299984T3 DK 09746975 T DK09746975 T DK 09746975T DK 2299984 T3 DK2299984 T3 DK 2299984T3
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Denmark
Prior art keywords
formulation
oral
drug core
certain embodiments
azacytidine
Prior art date
Application number
DK09746975.3T
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English (en)
Inventor
Jeffrey B Etter
Mei Lai
Jay Thomas Backstrom
Original Assignee
Celgene Corp
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Application filed by Celgene Corp filed Critical Celgene Corp
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Publication of DK2299984T3 publication Critical patent/DK2299984T3/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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (10)

1. Farmaceutisk sammensætning til anvendelse i en fremgangsmåde til behandling af et individ med cancer omfattende oral administration til individet af den farmaceutiske sammensætning omfattende en terapeutisk effektiv mængde 5-azacytidine, hvor sammensætningen er en sammensætning med øjeblikkelig afgivelse og hvor canceren er akut myelogenøs leukæmi.
2. Farmaceutisk sammensætning til anvendelse ifølge krav 1, der yderligere omfatter et yderligere terapeutisk middel.
3. Farmaceutisk sammensætning til anvendelse ifølge krav 1 eller 2, hvor sammensætningen er ikke-enterisk coatet.
4. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 3, hvor sammensætningen er i en enkeltenhedsdoseringsform.
5. Farmaceutisk sammensætning til anvendelse ifølge krav 4, hvor enkeltenhedsdoseringsformen er en tablet eller en kapsel.
6. Farmaceutisk sammensætning til anvendelse ifølge krav 5, hvor sammensætningen yderligere omfatter en excipiens valgt fra mannitol, mikrokrystallinsk cellulose, crospovidon, og magnesiumstearat, eller hvor sammensætningen yderligere omfatter en gennemtrængelighedsforstærker.
7. Farmaceutisk sammensætning til anvendelse ifølge krav 6, hvor gennemtrængelighedsforstærkeren er d-alfa-tocopherylpolyethylenglycol 1000 succinat, eventuelt hvor d-alfatocopherylpolyethylenglycol 1000 succinaten er til stede i formuleringen ved ca. 2 vægtprocent i forhold til formuleringens totalvægt.
8. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 7, der i det væsentlige er fri for en cytidin-deaminaseinhibitor, eller som i det væsentlige er fri for tetrahydrouridin.
9. Farmaceutisk sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 to 8, hvor sammensætningen opnår en område-under-kurven-værdi på mindst ca. 200 ng-hr/ml eller mindst ca. 400 ng-hr/ml efter oral administration, eller hvor sammensætningen opnåren maksimum plasmakoncentration på mindst ca. 100 ng/ml eller mindst ca. 200 ng/ml efter oral administration, eller hvor sammensætningen opnår en tid til maksimum plasmakoncentration på mindre end ca. 60 minutter, mindre end ca. 90 minutter, eller mindre end ca. 180 minutter efteroral administration til individet.
10. Sammensætningen ifølge et hvilket som helst af kravene 1 til 9, hvor individet er et menneske.
DK09746975.3T 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf DK2299984T3 (da)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US5360908P 2008-05-15 2008-05-15
US20114508P 2008-12-05 2008-12-05
US15787509P 2009-03-05 2009-03-05
PCT/US2009/002999 WO2009139888A1 (en) 2008-05-15 2009-05-14 Oral formulations of cytidine analogs and methods of use thereof

Publications (1)

Publication Number Publication Date
DK2299984T3 true DK2299984T3 (da) 2019-03-04

Family

ID=40941609

Family Applications (5)

Application Number Title Priority Date Filing Date
DK09746975.3T DK2299984T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK20201143.3T DK3782612T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK19213148.0T DK3692983T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK13182721.4T DK2695609T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK20201105.2T DK3782611T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf

Family Applications After (4)

Application Number Title Priority Date Filing Date
DK20201143.3T DK3782612T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK19213148.0T DK3692983T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK13182721.4T DK2695609T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf
DK20201105.2T DK3782611T3 (da) 2008-05-15 2009-05-14 Orale formuleringer af cytidinanaloger og fremgangsmåder til anvendelse deraf

Country Status (34)

Country Link
US (12) US8846628B2 (da)
EP (6) EP2695609B1 (da)
JP (3) JP2011520880A (da)
KR (1) KR101633134B1 (da)
CN (3) CN105535008A (da)
AR (1) AR071808A1 (da)
AU (3) AU2009246926B2 (da)
BR (1) BRPI0912717A2 (da)
CA (3) CA3094580C (da)
CL (2) CL2009001170A1 (da)
CO (1) CO6300930A2 (da)
CR (1) CR11789A (da)
CY (3) CY1121350T1 (da)
DK (5) DK2299984T3 (da)
EC (1) ECSP10010665A (da)
ES (5) ES2927556T3 (da)
FI (1) FI3782612T3 (da)
HR (5) HRP20221064T1 (da)
HU (5) HUE064677T2 (da)
IL (2) IL238087B (da)
LT (5) LT2695609T (da)
MX (2) MX363023B (da)
MY (1) MY161593A (da)
NI (1) NI201000193A (da)
NZ (3) NZ602833A (da)
PE (2) PE20091971A1 (da)
PL (5) PL3782611T3 (da)
PT (5) PT3782612T (da)
RU (3) RU2476207C2 (da)
SG (1) SG193206A1 (da)
SI (5) SI3692983T1 (da)
TW (3) TW201513869A (da)
WO (1) WO2009139888A1 (da)
ZA (1) ZA201008229B (da)

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