RU2010119926A - Твердый фармацевтический препарат матричного типа - Google Patents

Твердый фармацевтический препарат матричного типа Download PDF

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Publication number
RU2010119926A
RU2010119926A RU2010119926/15A RU2010119926A RU2010119926A RU 2010119926 A RU2010119926 A RU 2010119926A RU 2010119926/15 A RU2010119926/15 A RU 2010119926/15A RU 2010119926 A RU2010119926 A RU 2010119926A RU 2010119926 A RU2010119926 A RU 2010119926A
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solid preparation
sugar
preparation according
pharmaceutical solid
sugar alcohol
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RU2010119926/15A
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English (en)
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RU2465916C2 (ru
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Каи СУЗУКИ (JP)
Каи СУЗУКИ
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Оцука Фармасьютикал Ко., Лтд. (Jp)
Оцука Фармасьютикал Ко., Лтд.
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Application filed by Оцука Фармасьютикал Ко., Лтд. (Jp), Оцука Фармасьютикал Ко., Лтд. filed Critical Оцука Фармасьютикал Ко., Лтд. (Jp)
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    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Abstract

1. Фармацевтический твердый препарат матричного типа, включающий: ! (a) энтеросолюбильный полимер на основе метакриловой кислоты и ! (b) сахар и/или сахароспирт, в котором 1 г сахара и/или сахароспирта (b) может быть растворен в не больше чем 4 г воды в некоторой точке диапазона температуры воды от 20 до 25°C. ! 2. Фармацевтический твердый препарат по п.1, в котором количество сахара и/или сахароспирта составляет от 0,1 до 10 весовых частей в расчете на 1 весовую часть энтеросолюбильного полимера на основе метакриловой кислоты. ! 3. Фармацевтический твердый препарат по п.1 или 2, в котором сахар и/или сахароспирт имеет точку плавления 140°C или ниже. ! 4. Фармацевтический твердый препарат по п.1 или 2, не содержащий мягчителя. ! 5. Фармацевтический твердый препарат по п.3, не содержащий мягчителя. ! 6. Фармацевтический твердый препарат по п.1 или 2, полученный способом получения, включающим процесс экструзии. ! 7. Фармацевтический твердый препарат по п.3, полученный способом получения, включающим процесс экструзии.

Claims (7)

1. Фармацевтический твердый препарат матричного типа, включающий:
(a) энтеросолюбильный полимер на основе метакриловой кислоты и
(b) сахар и/или сахароспирт, в котором 1 г сахара и/или сахароспирта (b) может быть растворен в не больше чем 4 г воды в некоторой точке диапазона температуры воды от 20 до 25°C.
2. Фармацевтический твердый препарат по п.1, в котором количество сахара и/или сахароспирта составляет от 0,1 до 10 весовых частей в расчете на 1 весовую часть энтеросолюбильного полимера на основе метакриловой кислоты.
3. Фармацевтический твердый препарат по п.1 или 2, в котором сахар и/или сахароспирт имеет точку плавления 140°C или ниже.
4. Фармацевтический твердый препарат по п.1 или 2, не содержащий мягчителя.
5. Фармацевтический твердый препарат по п.3, не содержащий мягчителя.
6. Фармацевтический твердый препарат по п.1 или 2, полученный способом получения, включающим процесс экструзии.
7. Фармацевтический твердый препарат по п.3, полученный способом получения, включающим процесс экструзии.
RU2010119926/15A 2007-10-19 2008-09-26 Твердый фармацевтический препарат матричного типа RU2465916C2 (ru)

Applications Claiming Priority (2)

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JP2007-272700 2007-10-19
JP2007272700 2007-10-19

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RU2010119926A true RU2010119926A (ru) 2011-11-27
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RU2012132627/15A RU2600797C2 (ru) 2007-10-19 2012-07-30 Твердый фармацевтический препарат матричного типа

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US (2) US9072670B2 (ru)
EP (1) EP2180882B2 (ru)
JP (1) JP4879351B2 (ru)
KR (2) KR101600099B1 (ru)
CN (1) CN101854920B (ru)
AR (1) AR068910A1 (ru)
AU (1) AU2008313032B2 (ru)
BR (1) BRPI0817822A2 (ru)
CA (1) CA2702904A1 (ru)
CY (1) CY1114051T1 (ru)
DK (1) DK2180882T3 (ru)
ES (1) ES2406939T3 (ru)
HK (1) HK1144775A1 (ru)
HR (1) HRP20130498T1 (ru)
IL (1) IL204706A (ru)
MX (1) MX2010004178A (ru)
MY (1) MY147827A (ru)
PL (1) PL2180882T3 (ru)
PT (1) PT2180882E (ru)
RU (2) RU2465916C2 (ru)
SI (1) SI2180882T1 (ru)
TW (1) TWI433679B (ru)
WO (1) WO2009051022A2 (ru)
ZA (1) ZA201002211B (ru)

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US9289389B2 (en) 2016-03-22
WO2009051022A3 (en) 2009-06-25
AU2008313032B2 (en) 2013-05-02
CY1114051T1 (el) 2016-07-27
SI2180882T1 (sl) 2013-05-31
MX2010004178A (es) 2010-05-03
RU2012132627A (ru) 2014-02-10
CA2702904A1 (en) 2009-04-23
CN101854920A (zh) 2010-10-06
US20150150806A1 (en) 2015-06-04
MY147827A (en) 2013-01-31
US9072670B2 (en) 2015-07-07
KR20150064227A (ko) 2015-06-10
JP2011500511A (ja) 2011-01-06
HK1144775A1 (en) 2011-03-11
IL204706A (en) 2014-05-28
ZA201002211B (en) 2011-06-29
RU2465916C2 (ru) 2012-11-10
CN101854920B (zh) 2013-05-01
US20100233265A1 (en) 2010-09-16
DK2180882T3 (da) 2013-05-27
BRPI0817822A2 (pt) 2015-03-31
EP2180882B1 (en) 2013-03-27
IL204706A0 (en) 2010-11-30
PL2180882T3 (pl) 2013-08-30
AU2008313032A1 (en) 2009-04-23
TWI433679B (zh) 2014-04-11
KR20100087011A (ko) 2010-08-02
PT2180882E (pt) 2013-05-07
HRP20130498T1 (en) 2013-06-30
EP2180882A2 (en) 2010-05-05
WO2009051022A2 (en) 2009-04-23
JP4879351B2 (ja) 2012-02-22
TW200918079A (en) 2009-05-01
EP2180882B2 (en) 2017-06-28
RU2600797C2 (ru) 2016-10-27
AR068910A1 (es) 2009-12-16
KR101600099B1 (ko) 2016-03-04
ES2406939T3 (es) 2013-06-10

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