RU2006119916A - Способ получения субмикронных частиц паклитаксела - Google Patents
Способ получения субмикронных частиц паклитаксела Download PDFInfo
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- RU2006119916A RU2006119916A RU2006119916/15A RU2006119916A RU2006119916A RU 2006119916 A RU2006119916 A RU 2006119916A RU 2006119916/15 A RU2006119916/15 A RU 2006119916/15A RU 2006119916 A RU2006119916 A RU 2006119916A RU 2006119916 A RU2006119916 A RU 2006119916A
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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
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
-
- 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
- A61K31/12—Ketones
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
-
- 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
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- 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
-
- 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
- A61K9/127—Liposomes
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
Claims (34)
1. Способ получения фармацевтической композиции субмикронных частиц паклитаксела или его производных, растворимость которых выше в смешивающемся с водой первом растворителе, чем во втором растворителе, который является водным, причем способ включает стадии
(i) смешивания со смешивающимся с водой первым растворителем или со вторым растворителем или как со смешивающимся с водой первым растворителем, так и со вторым растворителем первого модификатора поверхности, включающего фосфолипид, конъюгированный с водорастворимым или гидрофильным полимером;
(ii) растворения паклитаксела или его производных в смешивающемся с водой первом растворителе с образованием раствора;
(iii) смешивания раствора со вторым растворителем с получением предварительной суспензии частиц;
(iv) гомогенизации предварительной суспензии с образованием суспензии мелких частиц, имеющих средний эффективный размер частиц менее приблизительно 1000 нм.
2. Способ по п.1, где фосфолипид является природным или синтетическим.
3. Способ по п.1, где фосфолипид представляет собой фосфатидилхолин, фосфатидилэтаноламин, диацилглицерофосфоэтаноламин, фосфатидилсерин, фосфатидилинозитол, фосфатидилглицерин, фосфатидную кислоту, лизофосфолипиды, фосфолипид яйца или сои или их комбинацию.
4. Способ по п.3, где диацилглицерофосфоэтаноламин выбирают из группы, состоящей из димиристоилглицерофосфоэтаноламина (DMPE), дипальмитоилглицерофосфоэтаноламина (DPPE), дистеароилглицерофосфоэтаноламина (DSPE) и диолеолилглицерофосфоэтаноламина (DOPE).
5. Способ по п.1, где растворимый или гидрофильный полимер, конъюгируемый с фосфолипидом, представляет собой полиэтиленгликоль (ПЭГ).
6. Способ по п.5, где ПЭГ выбирают из группы, состоящей из ПЭГ 350, ПЭГ 550, ПЭГ 750, ПЭГ 1000, ПЭГ 2000, ПЭГ 3000 и ПЭГ 5000.
7. Способ по п.1, где растворимый или гидрофильный полимер, конъюгируемый с фосфолипидом, выбран из группы, состоящей из декстрана, гидроксипропилметакрилата (HPMA) и полиглутамата.
8. Способ по п.1, дополнительно включающий смешивание со смешивающимся с водой первым растворителем или со вторым растворителем или как со смешивающимся с водой первым растворителем, так и со вторым растворителем второго модификатора поверхности, выбранного из группы, состоящей из анионного поверхностно-активного вещества, катионного поверхностно-активного вещества, анионных поверхностно-активных веществ, катионных поверхностно-активных веществ, неионных поверхностно-активных веществ и поверхностно-активных биологических модификаторов.
9. Способ по п.8, где второй модификатор поверхности представляет собой сополимер оксиэтилена и оксипропилена.
10. Способ по п.9, где сополимер оксиэтилена и оксипропилена представляет собой блок-сополимер оксиэтилена и оксипропилена.
11. Способ по п.8, где модификатор поверхности представляет собой полоксамер.
12. Способ по п.1, где смешиваемый с водой первый растворитель представляет собой N-метил-2-пирролидинон.
13. Способ по п.1, где гомогенизацию проводят при приблизительно 30°С или выше.
14. Способ по п.1, где мелкие частицы имеют средний эффективный размер частиц менее приблизительно 400 нм.
15. Способ по п.1, где мелкие частицы имеют средний эффективный размер частиц менее приблизительно 200 нм.
16. Способ по п.1, где мелкие частицы имеют средний эффективный размер частиц менее 150 нм.
17. Способ по п.1, дополнительно включающий стерилизацию композиции.
18. Способ по п.17, где стерилизация композиции включает стерильное фильтрование раствора и второго растворителя перед смешиванием и проведение последующих стадий в асептических условиях.
19. Способ по п.17, где стерилизация композиции включает стерильное фильтрование частиц.
20. Способ по п.17, где стерилизация включает стерилизацию нагреванием.
21. Способ по п.20, где стерилизация нагреванием достигается нагреванием в гомогенизаторе, где гомогенизатор служит в качестве средства нагрева и создания давления для стерилизации.
22. Способ по п.17, где стерилизация включает гамма-облучение.
23. Способ по п.1, дополнительно включающий удаление смешиваемого с водой первого растворителя из суспензии.
24. Способ по п.23, где удаление смешиваемого с водой первого растворителя осуществляется путем удаления первого растворителя фильтрованием.
25. Способ по п.24, где фильтрование представляет собой ультрафильтрацию с перекрестным потоком.
26. Способ по п.23, где удаление смешиваемого с водой первого растворителя производится одновременно с гомогенизацией.
27. Способ по п.1, дополнительно включающий удаление жидкой фазы суспензии для образования сухого порошка частиц.
28. Способ по п.27, где удаление жидкой фазы выбрано из группы, состоящей из выпаривания, выпаривания на роторном испарителе, лиофилизации, сушки замораживанием, диафильтрования, центрифугирования, фракционирования силовым полем, фильтрования высокого давления и обратного осмоса.
29. Способ по п.27, дополнительно включающий добавление разбавителя к сухому порошку.
30. Способ по п.29, где разбавитель пригоден для парентерального введения частиц.
31. Способ по п.1, где композиция составлена для введения путем, выбранным из парентерального, перорального, легочного, местного, глазного, назального, защечного, ректального, влагалищного и чрескожного.
32. Способ по п.1, где частицы являются нерастворимыми.
33. Способ по п.1, где частицы не агрегируют в условиях напряжения или при хранении.
34. Фармацевтическая композиция субмикронных частиц паклитаксела или его производных, полученная способом по п.1.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/703,395 US8067032B2 (en) | 2000-12-22 | 2003-11-07 | Method for preparing submicron particles of antineoplastic agents |
US10/703,395 | 2003-11-07 |
Publications (2)
Publication Number | Publication Date |
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RU2006119916A true RU2006119916A (ru) | 2007-12-20 |
RU2402313C2 RU2402313C2 (ru) | 2010-10-27 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2006119916/15A RU2402313C2 (ru) | 2003-11-07 | 2004-11-03 | Способ получения субмикронных частиц паклитаксела |
Country Status (17)
Country | Link |
---|---|
US (2) | US8067032B2 (ru) |
EP (1) | EP1682116B1 (ru) |
JP (1) | JP2007510657A (ru) |
KR (1) | KR101152458B1 (ru) |
CN (1) | CN100551365C (ru) |
AU (1) | AU2004289233B2 (ru) |
BR (1) | BRPI0416239A (ru) |
CA (1) | CA2540383A1 (ru) |
DK (1) | DK1682116T3 (ru) |
ES (1) | ES2388924T3 (ru) |
IL (1) | IL174031A (ru) |
NO (1) | NO20062552L (ru) |
NZ (1) | NZ546439A (ru) |
PL (1) | PL1682116T3 (ru) |
RU (1) | RU2402313C2 (ru) |
WO (1) | WO2005046671A1 (ru) |
ZA (1) | ZA200603547B (ru) |
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IL174031A0 (en) | 2006-08-01 |
CN100551365C (zh) | 2009-10-21 |
US20120070498A1 (en) | 2012-03-22 |
ES2388924T3 (es) | 2012-10-19 |
EP1682116A1 (en) | 2006-07-26 |
AU2004289233A1 (en) | 2005-05-26 |
RU2402313C2 (ru) | 2010-10-27 |
NZ546439A (en) | 2010-04-30 |
BRPI0416239A (pt) | 2007-01-09 |
NO20062552L (no) | 2006-06-02 |
CN1870987A (zh) | 2006-11-29 |
US20040245662A1 (en) | 2004-12-09 |
US8067032B2 (en) | 2011-11-29 |
ZA200603547B (en) | 2007-04-25 |
PL1682116T3 (pl) | 2012-10-31 |
IL174031A (en) | 2012-04-30 |
DK1682116T3 (da) | 2012-09-03 |
KR101152458B1 (ko) | 2012-06-01 |
JP2007510657A (ja) | 2007-04-26 |
EP1682116B1 (en) | 2012-05-30 |
CA2540383A1 (en) | 2005-05-26 |
AU2004289233B2 (en) | 2010-10-21 |
KR20060118455A (ko) | 2006-11-23 |
WO2005046671A1 (en) | 2005-05-26 |
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