RU2006119446A - Способ получения фармацевтических мультичастиц - Google Patents

Способ получения фармацевтических мультичастиц Download PDF

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Publication number
RU2006119446A
RU2006119446A RU2006119446/15A RU2006119446A RU2006119446A RU 2006119446 A RU2006119446 A RU 2006119446A RU 2006119446/15 A RU2006119446/15 A RU 2006119446/15A RU 2006119446 A RU2006119446 A RU 2006119446A RU 2006119446 A RU2006119446 A RU 2006119446A
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volatile compounds
specified
drug
activity
crystalline form
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RU2006119446/15A
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English (en)
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RU2331410C2 (ru
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Лиа Элизабет ЭППЕЛ (GB)
Лиа Элизабет ЭППЕЛ
Маршалл Дэвид КРЮ (GB)
Маршалл Дэвид Крю
Дуэйн Томас ФРИСЕН (GB)
Дуэйн Томас ФРИСЕН
Родерик Джек РЭЙ (GB)
Родерик Джек РЭЙ
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Пфайзер Продактс Инк. (Us)
Пфайзер Продактс Инк.
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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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • 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
    • A61K9/1635—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents

Claims (17)

1. Способ получения мультичастиц, включающий в себя использование лекарственного средства, существующего в кристаллической форме, содержащей летучие соединения с давлением пара по меньшей мере 0,01 атмосферы при рабочей температуре T с последующими стадиями:
(а) формирование расплавленной смеси, содержащей указанное лекарственное средство и носитель при указанной температуре T;
(b) формирование капель из указанной расплавленной смеси; и
(с) застывание указанных капель в среде застывания с получением мультичастиц, содержащих указанное лекарственное средство и указанный носитель, где указанные летучие соединения добавляют по меньшей мере на одной из стадий (a), (b) и (c).
2. Способ по п.1, где указанные летучие соединения добавляют на стадии (a) к указанной расплавленной смеси в количестве, достаточном для сохранения их активности в указанной расплавленной смеси равной или превышающей активность указанных летучих соединений в указанном лекарственном средстве в кристаллической форме.
3. Способ по п.1, где указанные летучие соединения добавляют на стадии (a) к первой среде, контактирующей с указанной расплавленной смесью, в количестве, достаточном для сохранения активности указанных летучих соединений в указанной первой среде, равной или превышающей активность указанных летучих соединений в указанном лекарственном средстве в кристаллической форме.
4. Способ по п.1, где указанные летучие соединения добавляют на стадии (b) ко второй среде, контактирующей с указанными каплями, в количестве, достаточном для сохранения активности указанных летучих соединений во второй среде, равной или превышающей активность указанных летучих соединений в указанном лекарственном средстве в кристаллической форме.
5. Способ по п.1, где указанные летучие соединения добавляют на стадии (c) к указанной среде застывания в количестве, достаточном для сохранения активности указанных летучих соединений в указанной среде застывания, равной или превышающей активность указанных летучих соединений в указанном лекарственном средстве в кристаллической форме.
6. Способ по п.1, где указанная расплавленная смесь стадии (a) дополнительно содержит усилитель растворения.
7. Способ по любому из пп.1-6, где указанные летучие соединения добавляют в количестве, достаточном для обеспечения относительной степени улучшения кристаллического состояния лекарственного средства по меньшей мере 1,1 по сравнению с мультичастицами, полученными контрольным способом, включающим в себя способ по п.1, стадии с (a) по (c).
8. Способ по любому из пп.1-6, где по меньшей мере 70 мас.% указанного лекарственного средства в указанной мультичастице находится в кристаллической форме.
9. Способ по любому из пп.1-6, где указанная кристаллическая форма представляет собой гидрат.
10. Способ по любому из пп.1-6, где указанная кристаллическая форма представляет собой сольват.
11. Способ по любому из пп.1-6, где указанная кристаллическая форма представляет собой форму соли, и указанным летучим соединением является противоион.
12. Способ по п.11, где указанный противоион представляет собой хлорид-ион.
13. Способ по п.2, где указанные летучие соединения вводят в экструдер, содержащий указанную расплавленную смесь.
14. Способ по любому из пп.1-6, где указанные летучие соединения находятся в виде пара.
15. Способ по любому из пп.1-6, где указанные летучие соединения находятся в виде жидкости.
16. Способ по любому из пп.1-6, где указанное лекарственное средство представляет собой азитромицин.
17. Способ по п.16, где указанная кристаллическая форма представляет собой азитромицина дигидрат, а указанным летучим соединением является вода.
RU2006119446/15A 2003-12-04 2004-11-24 Способ получения фармацевтических мультичастиц RU2331410C2 (ru)

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US52731603P 2003-12-04 2003-12-04
US60/527,316 2003-12-04

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RU2006119446A true RU2006119446A (ru) 2007-12-20
RU2331410C2 RU2331410C2 (ru) 2008-08-20

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US (1) US7951403B2 (ru)
EP (1) EP1691787B1 (ru)
JP (1) JP2007513145A (ru)
KR (1) KR100844628B1 (ru)
CN (1) CN1889932A (ru)
AR (1) AR046467A1 (ru)
AT (1) ATE399536T1 (ru)
AU (1) AU2004294817B2 (ru)
BR (1) BRPI0417360A (ru)
CA (1) CA2547774A1 (ru)
DE (1) DE602004014805D1 (ru)
DK (1) DK1691787T3 (ru)
ES (1) ES2308274T3 (ru)
IL (1) IL175655A0 (ru)
NO (1) NO20063113L (ru)
PL (1) PL1691787T3 (ru)
PT (1) PT1691787E (ru)
RU (1) RU2331410C2 (ru)
SI (1) SI1691787T1 (ru)
TW (1) TWI270381B (ru)
WO (1) WO2005053655A1 (ru)
ZA (1) ZA200604016B (ru)

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US7951403B2 (en) 2011-05-31
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JP2007513145A (ja) 2007-05-24
NO20063113L (no) 2006-09-04
DK1691787T3 (da) 2008-09-22
RU2331410C2 (ru) 2008-08-20
TW200529887A (en) 2005-09-16
AR046467A1 (es) 2005-12-07
AU2004294817B2 (en) 2007-01-25
CA2547774A1 (en) 2005-06-16
PT1691787E (pt) 2008-09-02
TWI270381B (en) 2007-01-11
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EP1691787A1 (en) 2006-08-23
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ZA200604016B (en) 2007-10-31
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SI1691787T1 (sl) 2008-10-31
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CN1889932A (zh) 2007-01-03
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EP1691787B1 (en) 2008-07-02
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