RU2009102934A - Композиции для ингаляции, содержащие соли гликопиррония - Google Patents
Композиции для ингаляции, содержащие соли гликопиррония Download PDFInfo
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- RU2009102934A RU2009102934A RU2009102934/15A RU2009102934A RU2009102934A RU 2009102934 A RU2009102934 A RU 2009102934A RU 2009102934/15 A RU2009102934/15 A RU 2009102934/15A RU 2009102934 A RU2009102934 A RU 2009102934A RU 2009102934 A RU2009102934 A RU 2009102934A
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- 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
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
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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
- A61K9/14—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
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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
- A61K9/14—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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- 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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- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Otolaryngology (AREA)
- Biophysics (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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- Pain & Pain Management (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
1. Способ получения сухих порошкообразных композиций соли гликопиррония для ингаляции, который заключается в том, что включает стадии (а) тонкого измельчения соли гликопиррония совместно с антиадгезивным агентом и (б) смешивание с частицами носителя, при этом получают сухую порошкообразную композицию. ! 2. Способ по п.1, где соль гликопиррония и антиадгезивный агент смешивают перед совместным измельчением. ! 3. Способ по п.1 или п.2, где антиадгезивным агентом является стеарат металла, кристаллический сахар или их смесь. ! 4. Способ по п.3, где антиадгезивным агентом является стеарат металла. ! 5. Способ по п.4, где стеаратом металла является стеарат магния или стеарат кальция. ! 6. Способ по п.4, где соль гликопиррония измельчают в смеси, содержащей от 1 до 20 мас.% стеарата металла. ! 7. Способ по п.6, где соль гликопиррония измельчают в смеси, содержащей от 2 до 10 мас.% стеарата металла. ! 8. Способ по п.1, в котором частицы носителя смешивают с тонкоизмельченной солью гликопиррония и антиадгезивного агента в массовом соотношении от 2000:1 до 5:1. ! 9. Способ по п.8, где частицы носителя смешивают с тонкоизмельченной солью гликопиррония и антиадгезивного агента в массовом соотношении от 200:1 до 20:1. ! 10. Способ по п.1, в котором частицами носителя являются кристаллические сахара. ! 11. Способ по п.1, в котором солью гликопиррония является бромид гликопиррония, хлорид гликопиррония или иодид гликопиррония. ! 12. Способ по п.11, где солью гликопиррония является бромид гликопиррония. ! 13. Способ по п.1, в котором соль гликопиррония и антиадгезивный агент тонко измельчают совместно с одним, двумя, тремя или более дополнительных активных ингредиентов. !
Claims (17)
1. Способ получения сухих порошкообразных композиций соли гликопиррония для ингаляции, который заключается в том, что включает стадии (а) тонкого измельчения соли гликопиррония совместно с антиадгезивным агентом и (б) смешивание с частицами носителя, при этом получают сухую порошкообразную композицию.
2. Способ по п.1, где соль гликопиррония и антиадгезивный агент смешивают перед совместным измельчением.
3. Способ по п.1 или п.2, где антиадгезивным агентом является стеарат металла, кристаллический сахар или их смесь.
4. Способ по п.3, где антиадгезивным агентом является стеарат металла.
5. Способ по п.4, где стеаратом металла является стеарат магния или стеарат кальция.
6. Способ по п.4, где соль гликопиррония измельчают в смеси, содержащей от 1 до 20 мас.% стеарата металла.
7. Способ по п.6, где соль гликопиррония измельчают в смеси, содержащей от 2 до 10 мас.% стеарата металла.
8. Способ по п.1, в котором частицы носителя смешивают с тонкоизмельченной солью гликопиррония и антиадгезивного агента в массовом соотношении от 2000:1 до 5:1.
9. Способ по п.8, где частицы носителя смешивают с тонкоизмельченной солью гликопиррония и антиадгезивного агента в массовом соотношении от 200:1 до 20:1.
10. Способ по п.1, в котором частицами носителя являются кристаллические сахара.
11. Способ по п.1, в котором солью гликопиррония является бромид гликопиррония, хлорид гликопиррония или иодид гликопиррония.
12. Способ по п.11, где солью гликопиррония является бромид гликопиррония.
13. Способ по п.1, в котором соль гликопиррония и антиадгезивный агент тонко измельчают совместно с одним, двумя, тремя или более дополнительных активных ингредиентов.
14. Способ по п.13, где полученный продукт смешивают с одним или более дополнительных активных ингредиентов, которые уже измельчены.
15. Способ по п.13 или п.14, где один или каждый дополнительный активный ингредиент выбирают из группы, состоящей из противовоспалительных, бронходилататорных, антигистаминных, противоотечных и противокашлевых лекарственных средств.
16. Способ по п.15, где один или каждый дополнительный активный ингредиент выбирают из группы, состоящей из агонистов β2-адреноцептора, антимускариновых агентов, стероидов, ингибиторов PDE4 или блокаторов кальциевых каналов.
17. Способ по п.16, где один или каждый дополнительный активный ингредиент выбирают из группы, состоящей из салметерола, индакатерола и мометазона.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0613161.9A GB0613161D0 (en) | 2006-06-30 | 2006-06-30 | Organic Compounds |
| GB0613161.9 | 2006-06-30 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2009102934A true RU2009102934A (ru) | 2010-08-10 |
| RU2453302C2 RU2453302C2 (ru) | 2012-06-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2009102934/15A RU2453302C2 (ru) | 2006-06-30 | 2007-06-28 | Композиции для ингаляции, содержащие соли гликопиррония |
Country Status (16)
| Country | Link |
|---|---|
| US (4) | US20090209502A1 (ru) |
| EP (1) | EP2037879B1 (ru) |
| JP (1) | JP5266213B2 (ru) |
| KR (1) | KR101400579B1 (ru) |
| CN (1) | CN101484134B (ru) |
| AU (1) | AU2007264000B2 (ru) |
| BR (1) | BRPI0713777B8 (ru) |
| CA (1) | CA2655381C (ru) |
| ES (1) | ES2424754T3 (ru) |
| FR (1) | FR13C0059I1 (ru) |
| GB (1) | GB0613161D0 (ru) |
| MX (1) | MX2008016356A (ru) |
| PL (1) | PL2037879T3 (ru) |
| PT (1) | PT2037879E (ru) |
| RU (1) | RU2453302C2 (ru) |
| WO (1) | WO2008000482A1 (ru) |
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| BR122019022692B1 (pt) | 2004-08-23 | 2023-01-10 | Mannkind Corporation | Composição terapêutica em pó seco contendo dicetopiperazina, pelo menos um tipo de cátion e um agente biologicamente ativo |
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| EP2234595B1 (en) * | 2007-12-13 | 2012-11-28 | Novartis AG | Process for reducing the tendency of a glycopyyronium salt to aggegate during storage. |
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| US8485180B2 (en) | 2008-06-13 | 2013-07-16 | Mannkind Corporation | Dry powder drug delivery system |
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| US20150224194A1 (en) | 2015-08-13 |
| CA2655381C (en) | 2014-10-21 |
| AU2007264000A1 (en) | 2008-01-03 |
| US20160081934A1 (en) | 2016-03-24 |
| FR13C0059I1 (fr) | 2013-12-13 |
| KR101400579B1 (ko) | 2014-05-28 |
| US20120065174A1 (en) | 2012-03-15 |
| US10314784B2 (en) | 2019-06-11 |
| CN101484134A (zh) | 2009-07-15 |
| BRPI0713777B8 (pt) | 2021-05-25 |
| PL2037879T3 (pl) | 2013-09-30 |
| JP2009541393A (ja) | 2009-11-26 |
| ES2424754T3 (es) | 2013-10-08 |
| RU2453302C2 (ru) | 2012-06-20 |
| CN101484134B (zh) | 2012-08-08 |
| CA2655381A1 (en) | 2008-01-03 |
| WO2008000482A1 (en) | 2008-01-03 |
| KR20090023650A (ko) | 2009-03-05 |
| EP2037879A1 (en) | 2009-03-25 |
| EP2037879B1 (en) | 2013-05-15 |
| GB0613161D0 (en) | 2006-08-09 |
| MX2008016356A (es) | 2009-01-16 |
| AU2007264000B2 (en) | 2011-06-09 |
| BRPI0713777B1 (pt) | 2019-08-27 |
| US20090209502A1 (en) | 2009-08-20 |
| PT2037879E (pt) | 2013-08-27 |
| JP5266213B2 (ja) | 2013-08-21 |
| BRPI0713777A2 (pt) | 2012-10-30 |
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