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ES2550033T3 - Forma de dosificación farmacéutica sólida de ticagrelor - Google Patents

Forma de dosificación farmacéutica sólida de ticagrelor Download PDF

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Publication number
ES2550033T3
ES2550033T3 ES10795382.0T ES10795382T ES2550033T3 ES 2550033 T3 ES2550033 T3 ES 2550033T3 ES 10795382 T ES10795382 T ES 10795382T ES 2550033 T3 ES2550033 T3 ES 2550033T3
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Spain
Prior art keywords
ticagrelor
dosage form
pharmaceutical dosage
solid pharmaceutical
ticagrelor solid
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Active
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ES10795382.0T
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English (en)
Inventor
Sandra Brueck
Dominique Meergans
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Ratiopharm GmbH
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Ratiopharm GmbH
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Publication date
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Application filed by Ratiopharm GmbH filed Critical Ratiopharm GmbH
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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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • 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
    • A61K9/145—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 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
    • A61K9/14—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
    • A61K9/2013—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
    • A61K9/2004—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Forma de dosificación farmacéutica oral sólida que comprende ticagrelor o una sal o un éster farmacéuticamente aceptables del mismo, caracterizada por que al menos el 90 % en volumen de las partículas de ticagrelor tienen un tamaño de partícula en el intervalo de 1 μm a 150 μm.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
E10795382
13-10-2015
Ejemplo 2
Ingredientes
Función mg/Comprimido % en peso
Ticagrelor
Ingrediente activo 90,0 52,0
Lactosa
Diluyente 72,0 41,6
Almidón de maíz
Disgregante 11,0 6,4
Peso total
173,0 100,0
Los comprimidos se prepararon usando un proceso similar al proceso descrito en el ejemplo 1.
Ejemplo 3
Ingredientes
Función mg/Comprimido % en peso
Ticagrelor
Ingrediente activo 90,0 54,9
Isomalt
Diluyente 72,0 43,9
Estearato de magnesio
Lubricante 2,0 1,2
Peso total
164,0 100,0
10 Las partículas de ticagrelor se prepararon usando un proceso de molienda en seco. El ticagrelor se molió usando un molino de chorro de aire. Posteriormente se añadió el diluyente al agente activo y se mezclaron en un mezclador de caída libre. El lubricante, estearato de magnesio se tamizó y se mezcló con la mezcla. Después la mezcla final se comprimió en comprimidos usando una prensa de comprimidos adecuada y después opcionalmente se recubrió con un material de recubrimiento, por ejemplo Opadry.
15
Ejemplo 4
Ingredientes
Función mg/Comprimido % en peso
Ticagrelor
Ingrediente activo 90,0 48,3
Hidroxipropilmetil celulosa (HPMC)
Aglomerante 18,0 9,7
SDS
Agente humectante 4,5 2,4
Manitol
Diluyente 64 34,3
Croscarmelosa
Disgregante 7,2 3,9
Sílice
Emoliente 0,9 0,5
Estearato de magnesio
Lubricante 1,8 1,0
Peso total
186,4 100,0
Las partículas de ticagrelor se prepararon usando un proceso de molienda en húmedo. La co-molienda se realizó
20 con ticagrelor junto con HPMC y SDS en un agente dispersante usando un molino húmedo. Posteriormente la suspensión se secó por atomización. La mitad de manitol, croscarmelosa y dióxido de sílice se añadieron a los intermedios secos, se mezclaron y se compactaron. Las partículas compactadas se tamizaron, posteriormente se añadieron los excipientes restantes y se mezclaron. Después la mezcla final se comprimió en comprimidos usando una prensa de comprimidos adecuada y después opcionalmente se recubrió con un material de recubrimiento, por
25 ejemplo Opadry.
Ejemplo 5
Ingredientes
Función mg/Comprimido % en peso
Ticagrelor
Ingrediente activo 90,0 46,7
Povidona
Aglutinante 45,0 23,4
SDS
Agente humectante 1,0 0,5
Celulosa microcristalina
Diluyente 45,0 23,4
Croscarmelosa
Disgregante 9,0 4,7
7
imagen6

Claims (1)

  1. imagen1
ES10795382.0T 2009-12-23 2010-12-20 Forma de dosificación farmacéutica sólida de ticagrelor Active ES2550033T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP09180628 2009-12-23
EP09180628 2009-12-23
PCT/EP2010/070268 WO2011076749A2 (en) 2009-12-23 2010-12-20 Solid pharmaceutical dosage form

Publications (1)

Publication Number Publication Date
ES2550033T3 true ES2550033T3 (es) 2015-11-04

Family

ID=43778442

Family Applications (2)

Application Number Title Priority Date Filing Date
ES10795382.0T Active ES2550033T3 (es) 2009-12-23 2010-12-20 Forma de dosificación farmacéutica sólida de ticagrelor
ES13169378.0T Active ES2548845T3 (es) 2009-12-23 2010-12-20 Forma de dosificación farmacéutica sólida de ticagrelor y ácido acetilsalicílico

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES13169378.0T Active ES2548845T3 (es) 2009-12-23 2010-12-20 Forma de dosificación farmacéutica sólida de ticagrelor y ácido acetilsalicílico

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Country Link
US (2) US8663661B2 (es)
EP (2) EP2633857B1 (es)
CA (1) CA2785487C (es)
EA (1) EA026094B1 (es)
ES (2) ES2550033T3 (es)
WO (1) WO2011076749A2 (es)

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Publication number Publication date
CA2785487A1 (en) 2011-06-30
WO2011076749A3 (en) 2011-08-18
EP2515871B1 (en) 2015-09-23
EA201200937A1 (ru) 2013-02-28
ES2548845T3 (es) 2015-10-21
EP2515871A2 (en) 2012-10-31
US8663661B2 (en) 2014-03-04
EP2633857B1 (en) 2015-08-12
CA2785487C (en) 2017-11-28
EA026094B1 (ru) 2017-03-31
WO2011076749A2 (en) 2011-06-30
US20140147505A1 (en) 2014-05-29
US20130028938A1 (en) 2013-01-31
EP2633857A1 (en) 2013-09-04

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