RU2004123625A - Способ получения гомогенных, высушенных распылением твердых аморфных дисперсий лекарственного средства с использованием модифицированной установки сушки распылением - Google Patents
Способ получения гомогенных, высушенных распылением твердых аморфных дисперсий лекарственного средства с использованием модифицированной установки сушки распылением Download PDFInfo
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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
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
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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
- A61K31/40—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
- A61K31/403—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 condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
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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
- A61K31/435—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
- A61K31/47—Quinolines; Isoquinolines
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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
- A61K9/10—Dispersions; Emulsions
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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
- A61K9/146—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
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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
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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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
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
- B01J2/04—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a gaseous medium
Claims (15)
1. Способ получения фармацевтической композиции, включающий стадии:
(а) получения исходного раствора, содержащего лекарственное средство, повышающий концентрацию полимер и растворитель;
(b) направления указанного исходного раствора в установку распылительной сушки, включающую
(i) сушильную камеру, имеющую объем Vdryer и высоту Н,
(ii) распыляющее средство для распыления указанного исходного раствора на капли,
(iii) источник нагретого осушающего газа для высушивания указанных капель при этом указанный источник доставляет указанный осушающий газ в указанную сушильную камеру при скорости потока G,
и
(iv) газо диспергирующее средство для диспергирования указанного осушающего газа в указанную сушильную камеру, при этом указанное газо диспергирующее средство создает организованный поршнеобразный ввод потока указанного осушающего газа,
где Vdryer измеряется, м3;
Н составляет, по меньшей мере, 1 м;
G измеряется, м3/с;
и соблюдается следующая математическая взаимозависимость
(с) распыления указанного исходного раствора на капли в указанной сушильной камере указанным распыляющим средством, при этом указанные капли имеют средний диаметр, по меньшей мере, 50 мкм и значение D10, по меньшей мере, 10 мкм;
(d) контактирования указанных капель с указанным нагретым осушающим газом с образованием частиц твердой аморфной дисперсии указанного лекарственного средства и указанного повышающего концентрацию полимера; и
(е) сбора указанных частиц,
где указанный повышающий концентрацию полимер присутствует в указанном растворе в количестве, достаточном для того, чтобы указанная твердая аморфная дисперсия обеспечивала повышение концентрации указанного лекарственного средства в среде его применения по сравнению с контрольной композицией, состоящей по существу только из эквивалентного количества указанного лекарственного средства.
2. Способ по п. 1, где указанное газо диспергирующее средство представляет собой перфорированную пластину.
3. Способ по п. 1, где указанный осушающий газ имеет температуру на входе от около 60 до около 300оС.
4. Способ по п. 3, где указанный осушающий газ имеет температуру на выходе от около 0 до около 100оС.
5. Способ по п. 1, где указанные капли имеют Спэн меньше, чем примерно 3.
6. Способ по п. 1, где, по меньшей мере, 80 об.% указанных частиц имеют диаметр больше, чем 10 мкм.
7. Способ по п. 1, где указанное лекарственное средство в указанной дисперсии является по существу аморфным, и указанная дисперсия является по существу гомогенной.
8. Способ по п. 1, где указанная композиция обеспечивает любую из следующих характеристик;
(а) максимальную концентрацию указанного лекарственного средства в указанной среде его применения, которая, по меньшей мере, в 1,25 раза превышает концентрацию, обеспечиваемую указанной контрольной композицией; или
(b) площадь под кривой концентрации лекарственного средства против времени в указанной среде применения в течение любого 90-минутного периода со времени введения лекарственного средства до около 270 мин после введения в указанную среду применения, которая, по меньшей мере, в 1,25 раза больше, чем обеспечиваемая указанной контрольной композицией.
9. Способ по п. 1, где указанная композиция обеспечивает относительную биодоступность указанного лекарственного средства, по меньшей мере, в 1,25 раз превышающую биодоступность контрольной композиции.
10. Способ по п. 1, где указанное лекарственное средство выбрано из группы, состоящей из антигипертензивных средств, седативных средств, тромболитических средств, противосудорожных средств, средств, понижающих уровень глюкозы в крови, противоотечных средств, антигистаминных средств, средств от кашля, противоопухолевых средств, бета-блокаторов, противовоспалительных средств, психотропных средств, средств для улучшения когнитивной функции, антиатеросклеротических средств, средств для снижения уровня холестерина, средств против ожирения, средств для лечения аутоиммунных заболеваний, средств против импотенции, антибактериальных и противогрибковых средств, снотворных средств, средств против болезни Паркинсона, средств против болезни Альцгеймера, антибиотиков, антидепрессантов, противовирусных средств, ингибиторов гликогенфосфорилазы и ингибиторов белка переноса сложного эфира холестерина (СЕТР).
11. Способ по п. 10, где указанное лекарственное средство выбрано из группы, состоящей из [R-(R*S*)]-5-хлор-N-[2-гидрокси-3-{метоксиметиламино}-3-оксо-1-(фенилметил)пропил-1Н-индол-2-карбоксамида; [(1S)-бензил-(2R)-гидрокси-3-((3R,4S)-дигидроксипирролидин-1-ил)-3-оксипропил]амида 5-хлор-1Н-индол-2-карбоновой кислоты; изопропилового эфира [2R,4S]-4-[ацетил-(3,5-бис-трифторметилбензил)-амино]-2-этил-6-трифторметил-3,4-дигидро-2Н-хинолин-1-карбоновой кислоты, этилового эфира [2R,4S]-4-[(3,5-бис-трифторметилбензил)-метоксикарбониламино]-2-этил-6-трифторметил-3,4-дигидро-2Н-хинолин-1-карбоновой кислоты и изопропилового эфира [2R,4S]-4-[(3,5-бис-трифторметилбензил)-метоксикарбониламино]-2-этил-6-трифторметил-3,4-дигидро-2Н-хинолин-1-карбоновой кислоты.
12. Способ по п. 1, где указанный повышающий концентрацию полимер выбран из группы, состоящей из ионизируемых целлюлозных полимеров, неионизируемых целлюлозных полимеров, ионизируемых нецеллюлозных полимеров, неионизируемых нецеллюлозных полимеров, нейтрализованных кислотных полимеров и их смесей.
13. Способ по п. 12, где указанный полимер выбран из группы, состоящей из гидроксипропилметилцеллюлозы, гидроксипропилцеллюлозы, карбоксиметилэтилцеллюлозы, гидроксипропилметилцеллюлозы ацетатсукцината, гидроксипропилметилцеллюлозы фталата, целлюлозы ацетатфталата, целлюлозы ацетаттримеллитат, поливиниловых спиртов, имеющих, по меньшей мере, часть своих повторяющихся звеньев в гидролизованной форме, поливинилпирролидона, полоксамеров и их смесей.
14. Продукт способа по любому из пп. 1-13.
15. Композиция, содержащая множество частиц твердой аморфной дисперсии, включающих лекарственное средство и полимер, где указанные частицы имеют средний диаметр, по меньшей мере, 40 мкм и насыпной удельный объем меньше, чем 5 мл/г, и где, по меньшей мере, 80 об.% указанных частиц имеют диаметр больше, чем 10 мкм.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US35408002P | 2002-02-01 | 2002-02-01 | |
US60/354,080 | 2002-02-01 |
Publications (3)
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RU2004123625A true RU2004123625A (ru) | 2006-01-27 |
RU2278659C2 RU2278659C2 (ru) | 2006-06-27 |
RU2278659C9 RU2278659C9 (ru) | 2007-02-20 |
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RU2004123625/15A RU2278659C9 (ru) | 2002-02-01 | 2003-01-20 | Способ получения гомогенных, высушенных распылением твердых аморфных дисперсий лекарственного средства с использованием модифицированной установки сушки распылением |
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US (6) | US6763607B2 (ru) |
EP (1) | EP1469833B1 (ru) |
JP (2) | JP4865989B2 (ru) |
KR (1) | KR100664822B1 (ru) |
CN (1) | CN1309370C (ru) |
BR (1) | BR0307333A (ru) |
CA (1) | CA2472028C (ru) |
ES (1) | ES2878403T3 (ru) |
GT (1) | GT200300018A (ru) |
HK (1) | HK1074164A1 (ru) |
HN (1) | HN2003000053A (ru) |
IL (1) | IL162819A0 (ru) |
MX (1) | MXPA04007433A (ru) |
PA (1) | PA8565301A1 (ru) |
PE (1) | PE20030805A1 (ru) |
PL (1) | PL372247A1 (ru) |
PT (1) | PT1469833T (ru) |
RS (1) | RS61604A (ru) |
RU (1) | RU2278659C9 (ru) |
TW (1) | TW200302749A (ru) |
UY (1) | UY27640A1 (ru) |
WO (1) | WO2003063822A2 (ru) |
ZA (1) | ZA200404882B (ru) |
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