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RU2018103213A - PHARMACEUTICAL COMPLEX COMPOSITION, INCLUDING AMLODIPINE, LOSARTAN AND ROSUVASTATIN - Google Patents

PHARMACEUTICAL COMPLEX COMPOSITION, INCLUDING AMLODIPINE, LOSARTAN AND ROSUVASTATIN Download PDF

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RU2018103213A
RU2018103213A RU2018103213A RU2018103213A RU2018103213A RU 2018103213 A RU2018103213 A RU 2018103213A RU 2018103213 A RU2018103213 A RU 2018103213A RU 2018103213 A RU2018103213 A RU 2018103213A RU 2018103213 A RU2018103213 A RU 2018103213A
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pharmaceutically acceptable
acceptable salt
rosuvastatin
pharmaceutical
mixture
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RU2018103213A
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RU2724338C2 (en
RU2018103213A3 (en
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Йонг Ил Ким
Хо Таек Им
Хиук Дзун ЧО
Йоунгсу ЙООН
Дзае Хиун Парк
Дзонг Соо Воо
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Ханми Фарм. Ко., Лтд.
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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Claims (29)

1. Фармацевтическая композиция для профилактики или лечения сердечно-сосудистого заболевания, включающая амлодипин или его фармацевтически приемлемую соль, розувастатин или его фармацевтически приемлемую соль, и лозартан или его фармацевтически приемлемую соль, где указанный розувастатин или его фармацевтически приемлемая соль имеют размер частиц (D90) 50 мкм или менее.1. A pharmaceutical composition for the prevention or treatment of cardiovascular disease, comprising amlodipine or a pharmaceutically acceptable salt thereof, rosuvastatin or a pharmaceutically acceptable salt thereof and losartan or a pharmaceutically acceptable salt thereof, wherein said rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) 50 μm or less. 2. Фармацевтическая композиция по п. 1, где розувастатин или его фармацевтически приемлемая соль имеет размер частиц (D90) 0,8-50 мкм.2. The pharmaceutical composition according to claim 1, wherein rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 0.8-50 μm. 3. Фармацевтическая композиция по п. 2, где розувастатин или его фармацевтически приемлемая соль имеет размер частиц (D90) 0,8-25 мкм.3. The pharmaceutical composition according to claim 2, wherein rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 0.8-25 μm. 4. Фармацевтическая композиция по п. 3, где розувастатин или его фармацевтически приемлемая соль имеет размер частиц (D90) 0,8-10 мкм.4. The pharmaceutical composition according to claim 3, wherein rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 0.8-10 μm. 5. Фармацевтическая композиция по п. 1, где скорость растворения розувастатина составляет 85% или более в течение 30 минут, когда композицию подвергают испытанию на растворимость в соответствии с USP лопастным методом в воде.5. The pharmaceutical composition according to claim 1, wherein the dissolution rate of rosuvastatin is 85% or more within 30 minutes, when the composition is subjected to a solubility test in accordance with the USP blade method in water. 6. Фармацевтическая композиция по п. 5, где скорость растворения розувастатина составляет 85% или более в течение 15 минут, когда композицию подвергают испытанию на растворимость в соответствии с USP лопастным методом в воде.6. The pharmaceutical composition according to claim 5, where the dissolution rate of rosuvastatin is 85% or more within 15 minutes, when the composition is subjected to a solubility test in accordance with the USP blade method in water. 7. Фармацевтическая комплексная композиция для профилактики или лечения сердечно-сосудистого заболевания, включающая7. A pharmaceutical complex composition for the prevention or treatment of cardiovascular disease, including первую смесь, включающую амлодипин или его фармацевтически приемлемую соль, розувастатин или его фармацевтически приемлемую соль, и фармацевтически приемлемую добавку; иa first mixture comprising amlodipine or a pharmaceutically acceptable salt thereof, rosuvastatin or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable additive; and вторую смесь, включающую лозартан или его фармацевтически приемлемую соль и фармацевтически приемлемую добавку,a second mixture comprising losartan or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive, где указанные первая и вторая смеси являются физически отделенными друг от друга иwhere the specified first and second mixtures are physically separated from each other and указанный розувастатин или его фармацевтически приемлемая соль имеет размер частиц (D90) 50 мкм или менее.said rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 50 μm or less. 8. Фармацевтическая комплексная композиция по п. 7, где фармацевтическая комплексная композиция находится в форме двухслойной таблетки, включающей8. The pharmaceutical complex composition according to claim 7, wherein the pharmaceutical complex composition is in the form of a two-layer tablet comprising первый слой, включающий амлодипин или его фармацевтически приемлемую соль, розувастатин или его фармацевтически приемлемую соль и фармацевтически приемлемую добавку; иa first layer comprising amlodipine or a pharmaceutically acceptable salt thereof, rosuvastatin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive; and второй слой, включающий лозартан или его фармацевтически приемлемую соль и фармацевтически приемлемую добавку.a second layer comprising losartan or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive. 9. Фармацевтическая комплексная композиция по п. 7, где первая смесь включает дезинтегрирующее средство в виде добавки.9. The pharmaceutical complex composition of claim 7, wherein the first mixture comprises a disintegrant in the form of an additive. 10. Фармацевтическая комплексная композиция по п. 9, где дезинтегрирующее средство содержится в количестве от 3 до 10 масс% на основании общей массы первой смеси.10. The pharmaceutical complex composition of claim 9, wherein the disintegrant is contained in an amount of from 3 to 10% by weight based on the total weight of the first mixture. 11. Фармацевтическая комплексная композиция по п. 9, где дезинтегрирующим средством является кросповидон, кроскармеллоза натрия, гликолат крахмала натрия, крахмал, пептизированный крахмал или их комбинация.11. The pharmaceutical complex composition of claim 9, wherein the disintegrant is crospovidone, croscarmellose sodium, sodium starch glycolate, starch, peptized starch, or a combination thereof. 12. Фармацевтическая комплексная композиция по п. 7, где первая смесь включает гидрат лактозы и микрокристаллическую целлюлозу в качестве добавок.12. The pharmaceutical complex composition of claim 7, wherein the first mixture comprises lactose hydrate and microcrystalline cellulose as additives. 13. Фармацевтическая комплексная композиция по п. 7, где вторая смесь находится в форме гранул, полученных методом роллерного прессования.13. The pharmaceutical complex composition according to claim 7, where the second mixture is in the form of granules obtained by roller pressing. 14. Способ получения фармацевтической комплексной композиции для профилактики или лечения сердечно-сосудистого заболевания, способ включает стадии:14. A method of obtaining a pharmaceutical complex composition for the prevention or treatment of cardiovascular disease, the method includes the steps of: a) смешивания амлодипина или его фармацевтически приемлемой соли, розувастатина или его фармацевтически приемлемой соли и фармацевтически приемлемой добавки; иa) mixing amlodipine or its pharmaceutically acceptable salt, rosuvastatin or its pharmaceutically acceptable salt and a pharmaceutically acceptable additive; and b) смешивания лозартана или его фармацевтически приемлемой соли и фармацевтически приемлемой добавки,b) mixing losartan or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive, где указанный розувастатин или его фармацевтически приемлемая соль имеют размер частиц (D90) 50 мкм или менее.wherein said rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 50 μm or less. 15. Способ по п. 14, где комплексная композиция является таблеткой или капсулой.15. The method according to p. 14, where the complex composition is a tablet or capsule. 16. Способ получения двухслойной таблетки для профилактики или лечения сердечно-сосудистого расстройства, способ включает стадии:16. A method of obtaining a two-layer tablet for the prevention or treatment of cardiovascular disorder, the method includes the steps of: a) смешивания амлодипина или его фармацевтически приемлемой соли, розувастатина или его фармацевтически приемлемой соли, и фармацевтически приемлемой добавки;a) mixing amlodipine or its pharmaceutically acceptable salt, rosuvastatin or its pharmaceutically acceptable salt, and a pharmaceutically acceptable additive; b) смешивания лозартана или его фармацевтически приемлемой соли и фармацевтически приемлемой добавки для получения смеси и затем гранулирования смеси; иb) mixing losartan or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive to form a mixture and then granulating the mixture; and c) таблетирования смеси, полученной на стадии a), и смеси, полученной на стадии b), для получения двухслойной таблетки,c) tableting the mixture obtained in stage a) and the mixture obtained in stage b) to obtain a two-layer tablet, где указанный розувастатин или его фармацевтически приемлемая соль имеют размер частиц (D90) 50 мкм или менее.wherein said rosuvastatin or a pharmaceutically acceptable salt thereof has a particle size (D 90 ) of 50 μm or less.
RU2018103213A 2015-06-30 2016-06-29 Pharmaceutical complex composition containing amlodipine, losartan and rosuvastatin RU2724338C2 (en)

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