RU2005122656A - Способы получения фармацевтических составов, содержащих дезагломерированные микрочастицы - Google Patents
Способы получения фармацевтических составов, содержащих дезагломерированные микрочастицы Download PDFInfo
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- RU2005122656A RU2005122656A RU2005122656/15A RU2005122656A RU2005122656A RU 2005122656 A RU2005122656 A RU 2005122656A RU 2005122656/15 A RU2005122656/15 A RU 2005122656/15A RU 2005122656 A RU2005122656 A RU 2005122656A RU 2005122656 A RU2005122656 A RU 2005122656A
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- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 claims 1
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims 1
- 229960003604 testosterone Drugs 0.000 claims 1
- PBJUNZJWGZTSKL-MRXNPFEDSA-N tiagabine Chemical compound C1=CSC(C(=CCCN2C[C@@H](CCC2)C(O)=O)C2=C(C=CS2)C)=C1C PBJUNZJWGZTSKL-MRXNPFEDSA-N 0.000 claims 1
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- XFYDIVBRZNQMJC-UHFFFAOYSA-N tizanidine Chemical compound ClC=1C=CC2=NSN=C2C=1NC1=NCCN1 XFYDIVBRZNQMJC-UHFFFAOYSA-N 0.000 claims 1
- 229960000488 tizanidine Drugs 0.000 claims 1
- 229960002117 triamcinolone acetonide Drugs 0.000 claims 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 claims 1
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 claims 1
- 229960001082 trimethoprim Drugs 0.000 claims 1
- NQPDZGIKBAWPEJ-UHFFFAOYSA-N valeric acid Chemical compound CCCCC(O)=O NQPDZGIKBAWPEJ-UHFFFAOYSA-N 0.000 claims 1
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims 1
- 229960004699 valsartan Drugs 0.000 claims 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
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Classifications
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- 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
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- 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
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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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- B—PERFORMING OPERATIONS; TRANSPORTING
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- 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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
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- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (38)
1. Способ получения фармацевтического состава в виде сухой порошковой смеси включающий формирование микрочастиц, которые содержат фармацевтическое средство; смешивание микрочастиц по меньшей мере с одним наполнителем, который представлен в форме частиц, имеющих среднеобъемный диаметр, превышающий среднеобъемный диаметр микрочастиц, для формирования порошковой смеси; и обработку порошковой смеси на струйной мельнице для дезагломерирования по меньшей мере части любых агломерированных микрочастиц, при сохранении, в основном, размера и морфологии отдельных микрочастиц.
2. Способ по п.1, в котором стадия обработки на струйной мельнице понижает остаточное содержание растворителя или влаги в сухой порошковой смеси по отношению к содержанию растворителя или влаги в сухой порошковой смеси, не обработанной на струйной мельнице, и/или улучшает способность сухой порошковой смеси к диспергированию, и/или понижает количество фармацевтического средства, которое содержится в сухой порошковой смеси в аморфном состоянии.
3. Способ по п. 1, в котором частицы наполнителя имеют среднеобъемный размер от 10 до 500 мкм.
4. Способ по п. 1, в котором наполнитель выбран из средств для увеличения объемности, консервантов, смачивающих средств, поверхностно активных веществ, осмотических средств, фармацевтически приемлемых носителей, разбавителей, связующих средств, дезинтегрирующих средств, средств для скольжения, смазывающих средств и сочетаний перечисленного.
5. Способ по п. 1, в котором наполнитель выбран из липидов, сахаров, аминокислот и полиоксиэтилен сорбитановых эфиров жирных кислот, а также сочетаний перечисленного.
6. Способ по п. 1, в котором наполнитель выбран из лактозы, маннита, сорбита, трегалозы, ксилита и сочетаний перечисленного.
7. Способ по п.1, в котором наполнитель выбран из связующих веществ, дезинтегрирующих средств, средств для скольжения, разбавителей, красящих веществ, наполнителей, подсластителей, смазывающих веществ, и сочетаний перечисленного, которые подходят для использования в твердых лекарственных формах для перорального дозирования.
8. Способ по п. 1, в котором с микрочастицами смешивают два или более наполнителей.
9. Способ по п.8, в котором два или более наполнителей смешивают друг с другом на стадии сухого или жидкостного смешивания с образованием смеси наполнителей, которую затем смешивают с микрочастицами.
10. Способ по п.8, в котором два или более наполнителей и микрочастицы смешивают вместе в одну стадию.
11. Способ по п. 1, в котором микрочастицы дополнительно включают биосовместимый полимер.
12. Фармацевтическая композиция, содержащая сухую порошковую смесь, полученную способом по любому из пп. 1-11.
13. Способ получения микрочастиц для использования в фармацевтических составах, включающий (a) формирование микрочастиц с помощью способа распылительной сушки, который включает распыление через распылитель эмульсии, раствора или суспензии, которые содержат растворитель и фармацевтическое средство, для образования капелек растворителя и фармацевтического средства; и выпаривание части растворителя для затвердевания капелек и формирования микрочастиц; и
(b) Обработку микрочастиц на струйной мельнице для дезагломерирования по меньшей мере части агломерированных микрочастиц, если таковые образуются, при сохранении, в основном, размеров и морфологии отдельных микрочастиц.
14. Способ по п.13, в котором стадия обработки на струйной мельнице снижает остаточное содержание растворителя или влаги в микрочастицах, по отношению к содержанию растворителя или влаги в микрочастицах, не обработанных на струйной мельнице, и/или улучшает способность микрочастиц к диспергированию, и/или понижает количество фармацевтического средства, которое содержится в микрочастицах в аморфном состоянии.
15. Способ по п. 13, дополнительно включающий смешивание микрочастиц с одним или более наполнителями и/или со второй порцией микрочастиц, которые содержат второе фармацевтическое средство, до обработки на струйной мельнице, после обработки на струйной мельнице или как до, так и после обработки микрочастиц на струйной мельнице.
16. Способ по п. 13, в котором эмульсия, раствор или суспензия дополнительно содержат биосовместимый полимер.
17. Способ по п. 11, в котором биосовместимый полимер представляет собой синтетический полимер, выбранный из поли(оксикислот), полиангидридов, сложных поли(орто)эфиров, полиуретанов, поли(масляной кислоты), поли(валериановой кислоты), поли(лактида-со-капролактона), а также смесей и сополимеров перечисленных веществ.
18. Способ по п. 13, в котором эмульсия, раствор или суспензия дополнительно содержат вещество оболочки.
19. Способ по п. 1 или 13, в котором микрочастицы содержат вещество оболочки, окружающее ядро из фармацевтического средства.
20. Фармацевтический состав, содержащий микрочастицы, полученные способом по п. 13.
21. Способ получения фармацевтических составов, содержащих микрочастицы, причем способ включает формирование микрочастиц, которые содержат фармацевтическое средство и вещество оболочки; и обработку микрочастиц на струйной мельнице для дезагломерирования по меньшей мере части любых агломерированных микрочастиц, с сохранением, в основном, размеров и морфологии отдельных микрочастиц.
22. Способ по п. 21, дополнительно включающий смешивание микрочастиц с одним или более наполнителями до обработки на струйной мельнице, после обработки на струйной мельнице, или как до, так и после обработки микрочастиц на струйной мельнице.
23. Способ по п. 21, в котором фармацевтическое средство диспергировано по всему объему вещества оболочки.
24. Способ по п. 21, в котором микрочастицы содержат ядро из фармацевтического средства, которое окружено веществом оболочки.
25. Фармацевтическая композиция, содержащая дезагломерированные микрочастицы, полученные способом по п. 21.
26. Фармацевтическая композиция, содержащая дезагломерированные микрочастицы, полученные способом по п.22, где вещество оболочки содержит сахар или аминокислоту и наполнитель содержит сахар или аминокислоту, которые выступают в роли средства для придания объемности или тонизирующего средства.
27. Способ по п. 21, в котором вещество оболочки выбрано из полимеров, аминокислот, сахаров, белков, углеводородов и липидов.
28. Способ по п. 1 или 21, в котором микрочастицы формируют с помощью процесса распылительной сушки.
29. Способ по любому из п. 1, 13 и 21, в котором обработка на струйной мельнице выполняется с применением подаваемого газа и/или размалывающего газа, поступающего на струйную мельницу при температуре ниже приблизительно 100°C.
30. Способ по пп. 1, 14 или 22, в котором микрочастицы имеют среднечисловой размер от 1 до 10 мкм.
31. Способ по пп. 1, 13 или 21, в котором микрочастицы имеют среднеобъемный размер от 2 до 50 мкм.
32. Способ по пп. 1, 13 или 21, в котором микрочастицы имеют аэродинамический диаметр от 1 до 50 мкм.
33. Способ по пп. 1, 13 или 21, в котором микрочастицы включают микросферы, содержащие внутри себя пустоты или поры.
34. Способ по пп. 1, 13 или 21, в котором фармацевтическое средство представляет собой терапевтическое или профилактическое средство.
35. Способ по п.34, в котором терапевтическое или профилактическое средство является гидрофобным, и микрочастицы включают микросферы, содержащие внутри себя пустоты или поры.
36. Способ по п.34, в котором терапевтическое или фармацевтическое средство выбрано из нестероидных противовоспалительных средств, кортикостероидов, противоопухолевых препаратов, противомикробных средств, противовирусных средств, антибактериальных средств, противогрибковых средств, антиастматических средств, бронхолитических средств, антигистаминных препаратов, иммунодепрессантов, средств против тревожных состояний, седативных/снотворных средств, антипсихотических средств, противосудорожных средств и блокаторов кальциевых каналов.
37. Способ по п.34, в котором терапевтическое или профилактическое средство выбрано из целекоксиба, рофекоксиба, доцетаксела, паклитаксела, ацикловира, албутерола, алпразолама, амиодарона, амоксициллина, анагрелида, бактрима, беклометазона дипропионата, биаксина, будезонида, булсульфана, кальцитонина, карбамазепина, цефтазидима, цефпрозила, ципрофлоксацина, кларитромицина, клозапина, циклоспорина, диазепама, эстрадиола, этодолака, фамцикловира, фенофибрата, фексофенадина, фомотерола, флунизолида, флутиказона пропионата, гемцитабина, ганцикловира, колониестимулирующего фактора гранулоцитов, инсулина, итраконазола, ламотригина, лейпролида, лоратидина, лоразепама, мелоксикама, мезаламина, миноциклина, модафинила, мометазона, набуметона, нелфинавира мезилата, оланзапина, окскарбазепина; пептида, родственного паратиреоидному гормону; фенитоина, прогестерона, пропфола, ритинавира, салметреола, сиролимуса, SN-38, соматостатина, сульфаметоксазола, сульфасалазина, тестостерона, такролимуса, тиагабина, тизанидина, триамцинолона ацетонида, триметоприма, валсартана, вориконазола, зафирлукаста, зилеутона и ципразидона.
38. Способ по пп. 1, 13 или 21, в котором фармацевтическое средство включает диагностическое средство.
Applications Claiming Priority (2)
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| US10/324,558 US20040121003A1 (en) | 2002-12-19 | 2002-12-19 | Methods for making pharmaceutical formulations comprising deagglomerated microparticles |
| US10/324,558 | 2002-12-19 |
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| RU2005122656A true RU2005122656A (ru) | 2006-01-20 |
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| US (4) | US20040121003A1 (ru) |
| EP (1) | EP1575560A2 (ru) |
| JP (1) | JP2006514044A (ru) |
| KR (1) | KR20050088201A (ru) |
| CN (1) | CN1726009A (ru) |
| AU (1) | AU2003295698A1 (ru) |
| BR (1) | BR0317611A (ru) |
| CA (1) | CA2511313A1 (ru) |
| RU (1) | RU2005122656A (ru) |
| WO (1) | WO2004060344A2 (ru) |
| ZA (1) | ZA200504213B (ru) |
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|---|---|
| BR0317611A (pt) | 2005-11-29 |
| AU2003295698A1 (en) | 2004-07-29 |
| US20050079138A1 (en) | 2005-04-14 |
| KR20050088201A (ko) | 2005-09-02 |
| US20040121003A1 (en) | 2004-06-24 |
| WO2004060344A3 (en) | 2004-12-02 |
| JP2006514044A (ja) | 2006-04-27 |
| US20060093678A1 (en) | 2006-05-04 |
| CN1726009A (zh) | 2006-01-25 |
| EP1575560A2 (en) | 2005-09-21 |
| US20060093677A1 (en) | 2006-05-04 |
| ZA200504213B (en) | 2006-02-22 |
| CA2511313A1 (en) | 2004-07-22 |
| WO2004060344A2 (en) | 2004-07-22 |
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| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
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