RU2012122450A - PARTICULAR COMPOSITION AND METHOD FOR PRODUCING IT - Google Patents

PARTICULAR COMPOSITION AND METHOD FOR PRODUCING IT Download PDF

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RU2012122450A
RU2012122450A RU2012122450/15A RU2012122450A RU2012122450A RU 2012122450 A RU2012122450 A RU 2012122450A RU 2012122450/15 A RU2012122450/15 A RU 2012122450/15A RU 2012122450 A RU2012122450 A RU 2012122450A RU 2012122450 A RU2012122450 A RU 2012122450A
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particles
composition
particulate composition
coating layer
water
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RU2012122450/15A
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RU2648353C2 (en
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Тацуя КОНИСИ
Дайсуке АСАРИ
Такуя СИСИДО
Аримити ОКАЗАКИ
Мицухико ХОРИ
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Нитто Денко Корпорейшн
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Priority claimed from JP2011123721A external-priority patent/JP2012250926A/en
Priority claimed from JP2011141058A external-priority patent/JP5813391B2/en
Priority claimed from JP2012106978A external-priority patent/JP2013040161A/en
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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Pharmacology & Pharmacy (AREA)
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Abstract

1. Композиция в виде частиц, содержащая частицы лекарственного средства и первый слой покрытия, нанесенный на указанные частицы лекарственного средства, отличающийся тем, что указанный первый слой покрытия содержит водонерастворимый полимер, неорганические частицы и/или липидный компонент и указанный липидный компонент содержит Cили более высокомолекулярную жирную кислоту.2. Композиция в виде частиц по п.1, в которой водонерастворимый полимер содержит кишечнорастворимый полимер.3. Композиция в виде частиц по п.1, в которой средний диаметр частиц для неорганических частиц составляет от 1 до 1000 нм.4. Композиция в виде частиц по п.1, в которой неорганические частицы состоят из диоксида кремния и/или диоксида титана.5. Композиция в виде частиц по п.1, в которой неорганические частицы подвергаются воздействию гидрофобизации.6. Композиция в виде частиц по п.1, в которой неорганические частицы содержатся в количестве от 0,5 до 2,4 массовой доли на 2,4 массовой доли водонерастворимого полимера.7. Композиция в виде частиц по п.1, в которой неорганические частицы содержатся в количестве от 0,5 до 2,4 массовой доли на 2,4 массовой доли частиц лекарственного средства.8. Композиция в виде частиц по п.1, в которой липидный компонент содержит C-Cжирную кислоту.9. Композиция в виде частиц по п.8, в которой C-Cжирная кислота представляет собой стеариновую кислоту.10. Композиция в виде частиц по п.1, в которой липидный компонент содержится в количестве от 0,1 до 0,8 массовой доли на 2,4 массовой доли водонерастворимого полимера.11. Композиция в виде частиц по п.1, дополнительно содержащая второй слой покрытия, покрывающий первый слой покрытия.12. Композиция �1. A composition in the form of particles containing particles of a drug and a first coating layer applied to said particles of a drug, characterized in that said first coating layer contains a water-insoluble polymer, inorganic particles and / or lipid component and said lipid component contains a higher molecular weight fatty acid. 2. A particulate composition according to claim 1, wherein the water-insoluble polymer comprises an enteric polymer. The particle composition according to claim 1, in which the average particle diameter for inorganic particles is from 1 to 1000 nm. A particulate composition according to claim 1, wherein the inorganic particles are composed of silicon dioxide and / or titanium dioxide. A particulate composition according to claim 1, wherein the inorganic particles are exposed to hydrophobization. A particulate composition according to claim 1, wherein the inorganic particles are contained in an amount of from 0.5 to 2.4 mass fractions per 2.4 mass fractions of a water-insoluble polymer. A particulate composition according to claim 1, wherein the inorganic particles are contained in an amount of from 0.5 to 2.4 mass fractions per 2.4 mass fractions of the drug particles. The particulate composition according to claim 1, wherein the lipid component contains C-C fatty acid. The particulate composition of claim 8, wherein the C-C fatty acid is stearic acid. The particulate composition according to claim 1, in which the lipid component is contained in an amount of from 0.1 to 0.8 mass fraction by 2.4 mass fraction of a water-insoluble polymer. The particulate composition according to claim 1, further comprising a second coating layer covering the first coating layer. Composition �

Claims (20)

1. Композиция в виде частиц, содержащая частицы лекарственного средства и первый слой покрытия, нанесенный на указанные частицы лекарственного средства, отличающийся тем, что указанный первый слой покрытия содержит водонерастворимый полимер, неорганические частицы и/или липидный компонент и указанный липидный компонент содержит C15 или более высокомолекулярную жирную кислоту.1. A particulate composition comprising particles of a drug and a first coating layer applied to said particles of a drug, characterized in that said first coating layer contains a water-insoluble polymer, inorganic particles and / or a lipid component and said lipid component contains C 15 or higher molecular weight fatty acid. 2. Композиция в виде частиц по п.1, в которой водонерастворимый полимер содержит кишечнорастворимый полимер.2. The particulate composition of claim 1, wherein the water-insoluble polymer comprises an enteric polymer. 3. Композиция в виде частиц по п.1, в которой средний диаметр частиц для неорганических частиц составляет от 1 до 1000 нм.3. The composition in the form of particles according to claim 1, in which the average particle diameter for inorganic particles is from 1 to 1000 nm. 4. Композиция в виде частиц по п.1, в которой неорганические частицы состоят из диоксида кремния и/или диоксида титана.4. The particulate composition according to claim 1, in which the inorganic particles are composed of silicon dioxide and / or titanium dioxide. 5. Композиция в виде частиц по п.1, в которой неорганические частицы подвергаются воздействию гидрофобизации.5. The composition in the form of particles according to claim 1, in which inorganic particles are exposed to hydrophobization. 6. Композиция в виде частиц по п.1, в которой неорганические частицы содержатся в количестве от 0,5 до 2,4 массовой доли на 2,4 массовой доли водонерастворимого полимера.6. The composition in the form of particles according to claim 1, in which inorganic particles are contained in an amount of from 0.5 to 2.4 mass fractions per 2.4 mass fractions of a water-insoluble polymer. 7. Композиция в виде частиц по п.1, в которой неорганические частицы содержатся в количестве от 0,5 до 2,4 массовой доли на 2,4 массовой доли частиц лекарственного средства.7. The composition in the form of particles according to claim 1, in which the inorganic particles are contained in an amount of from 0.5 to 2.4 mass fractions per 2.4 mass fractions of particles of the drug. 8. Композиция в виде частиц по п.1, в которой липидный компонент содержит C15-C21 жирную кислоту.8. The particulate composition according to claim 1, in which the lipid component contains a C 15 -C 21 fatty acid. 9. Композиция в виде частиц по п.8, в которой C15-C21 жирная кислота представляет собой стеариновую кислоту.9. The particulate composition of claim 8, wherein the C 15 -C 21 fatty acid is stearic acid. 10. Композиция в виде частиц по п.1, в которой липидный компонент содержится в количестве от 0,1 до 0,8 массовой доли на 2,4 массовой доли водонерастворимого полимера.10. The composition in the form of particles according to claim 1, in which the lipid component is contained in an amount from 0.1 to 0.8 mass fraction by 2.4 mass fraction of a water-insoluble polymer. 11. Композиция в виде частиц по п.1, дополнительно содержащая второй слой покрытия, покрывающий первый слой покрытия.11. The particulate composition according to claim 1, further comprising a second coating layer covering the first coating layer. 12. Композиция в виде частиц по п.11, где первый слой покрытия содержит кишечнорастворимый полимер целлюлозы, и второй слой покрытия содержит водонерастворимый полимер, отличный от указанного кишечнорастворимого полимера целлюлозы.12. The particulate composition of claim 11, wherein the first coating layer contains an enteric polymer of cellulose and the second coating layer contains a water-insoluble polymer other than said enteric polymer of cellulose. 13. Композиция в виде частиц по п.12, в которой кишечнорастворимый полимер целлюлозы включает фталат гидроксипропилметилцеллюлозы (HPMCP) и/или ацетат сукцинат гидроксипропилметилцеллюлозы (HPMCAS).13. The particle composition of claim 12, wherein the enteric cellulose polymer comprises hydroxypropyl methyl cellulose phthalate (HPMCP) and / or hydroxypropyl methyl cellulose acetate succinate (HPMCAS). 14. Композиция в виде частиц по п.12, в которой водонерастворимый полимер, отличный от кишечнорастворимого полимера целлюлозы, содержит, по меньшей мере, один вид полимера, выбранный из группы, состоящей из этилцеллюлозы, сополимера метакриловой кислоты-метилакрилата, сополимера метилметакрилата-бутилметакрилата-диметиламиноэтилметакрилата, поливинилацеталя диэтиламиноацетата, сополимера этилакрилата-метилметакрилата-хлортриметиламмония этилметакрилата и сополимера этилакрилата-метилметакрилата.14. The particulate composition of claim 12, wherein the water-insoluble polymer other than the enteric polymer of cellulose comprises at least one polymer selected from the group consisting of ethyl cellulose, a methacrylic acid-methyl acrylate copolymer, a methyl methacrylate-butyl methacrylate copolymer dimethylaminoethyl methacrylate, diethylaminoacetate polyvinyl acetal, ethyl acrylate-methyl methacrylate-chlorotrimethylammonium copolymer of ethyl methacrylate and ethyl acrylate-methyl methacrylate copolymer. 15. Композиция в виде частиц по п.1, имеющая средний диаметр частиц от 0,1 до 200 мкм.15. The composition in the form of particles according to claim 1, having an average particle diameter of from 0.1 to 200 microns. 16. Способ получения композиции в виде частиц, включающий стадии:16. A method of obtaining a composition in the form of particles, comprising the steps of: формирования первого слоя покрытия на частицах лекарственного средства посредством растворения и/или суспендирования указанных частиц лекарственного средства в первом растворе покрытия, содержащем кишечнорастворимый полимер целлюлозы, и осуществления способа сушки распылением; иforming a first coating layer on the particles of the drug by dissolving and / or suspending said particles of the drug in a first coating solution containing an enteric polymer of cellulose, and implementing a spray drying method; and формирования второго слоя покрытия посредством суспендирования указанных частиц лекарственного средства, с нанесенным на них указанным первым слоем покрытия во втором растворе покрытия, содержащем водонерастворимый полимер, отличный от указанного кишечнорастворимого полимера целлюлозы, и осуществления способа сушки распылением.forming a second coating layer by suspending said drug particles with said first coating layer applied thereto in a second coating solution containing a water-insoluble polymer other than said enteric-soluble cellulose polymer, and implementing a spray drying method. 17. Способ получения композиции в виде частиц по п.16, в котором первый раствор покрытия содержит первый полярный растворитель.17. The method of obtaining a composition in the form of particles according to clause 16, in which the first coating solution contains a first polar solvent. 18. Способ получения композиции в виде частиц по п.17, в котором первый полярный растворитель представляет собой ацетон.18. The method of obtaining a composition in the form of particles according to 17, in which the first polar solvent is acetone. 19. Способ получения композиции в виде частиц по п.16, в котором второй раствор покрытия содержит второй полярный растворитель, отличный от первого полярного растворителя.19. The method of producing a particulate composition according to clause 16, in which the second coating solution contains a second polar solvent other than the first polar solvent. 20. Способ получения композиции в виде частиц по п.19, в котором второй полярный растворитель представляет собой этанол. 20. A method for producing a particulate composition according to claim 19, wherein the second polar solvent is ethanol.
RU2012122450A 2011-06-01 2012-05-30 Particulate composition and process for obtaining it RU2648353C2 (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
JP2011123721A JP2012250926A (en) 2011-06-01 2011-06-01 Particulate formulation
JP2011-123721 2011-06-01
JP2011-141058 2011-06-24
JP2011141058A JP5813391B2 (en) 2011-06-24 2011-06-24 Method for producing particle preparation
JP2011157010 2011-07-15
JP2011-157010 2011-07-15
JP2012-106978 2012-05-08
JP2012106978A JP2013040161A (en) 2011-07-15 2012-05-08 Particulate preparation

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RU2648353C2 RU2648353C2 (en) 2018-03-23

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