RU2010111356A - Медицинские устройства и способы, включающие полимеры, содержащие биологически активные вещества - Google Patents
Медицинские устройства и способы, включающие полимеры, содержащие биологически активные вещества Download PDFInfo
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- 229920000642 polymer Polymers 0.000 title claims abstract 10
- 238000000034 method Methods 0.000 title claims 8
- 239000013543 active substance Substances 0.000 title 1
- 229940088623 biologically active substance Drugs 0.000 claims abstract 23
- GJSURZIOUXUGAL-UHFFFAOYSA-N Clonidine Chemical compound ClC1=CC=CC(Cl)=C1NC1=NCCN1 GJSURZIOUXUGAL-UHFFFAOYSA-N 0.000 claims abstract 12
- 229960002896 clonidine Drugs 0.000 claims abstract 12
- 239000002245 particle Substances 0.000 claims abstract 9
- 239000000203 mixture Substances 0.000 claims abstract 6
- 229920001710 Polyorthoester Polymers 0.000 claims abstract 4
- 229920002988 biodegradable polymer Polymers 0.000 claims abstract 4
- 239000004621 biodegradable polymer Substances 0.000 claims abstract 4
- 229920001577 copolymer Polymers 0.000 claims abstract 4
- 229920000747 poly(lactic acid) Polymers 0.000 claims abstract 4
- 239000002745 poly(ortho ester) Substances 0.000 claims abstract 4
- 238000010828 elution Methods 0.000 claims abstract 2
- 230000004962 physiological condition Effects 0.000 claims abstract 2
- 239000000843 powder Substances 0.000 claims 11
- 229940079593 drug Drugs 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 6
- 239000012803 melt mixture Substances 0.000 claims 4
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 239000007788 liquid Substances 0.000 claims 2
- 229940126601 medicinal product Drugs 0.000 claims 2
- 238000001694 spray drying Methods 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 210000003497 sciatic nerve Anatomy 0.000 claims 1
- 239000007921 spray Substances 0.000 claims 1
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Abstract
1. Имплантируемое медицинское устройство, содержащее: ! по меньшей мере один биодеградируемый полимер в количестве примерно 2-99% от массы указанного имплантируемого медицинского устройства; ! по меньшей мере одно биологически активное вещество в количестве примерно 1-60% от массы указанного имплантируемого медицинского устройства, причем биологически активное вещество находится в композиции в виде частиц, при этом по меньшей мере 80% частиц имеют размер в интервале от 5 до 50 мкм в диаметре, а указанное биологически активное вещество представляет собой клонидин. ! 2. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанное имплантируемое медицинское устройство обеспечивает профиль элюирования, при котором менее 80% биологически активного вещества элюируется через 60 дней после того, как имплантируемое медицинское устройство было имплантировано пациенту в физиологических условиях. ! 3. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанный полимер выбран из группы, включающей сополимер полилактида с гликолидом, полилактид, сложный полиортоэфир, и их комбинации. ! 4. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанный полимер имеет аморфную структуру, а биологически активное вещество имеет кристаллическую структуру. ! 5. Имплантируемое медицинское устройство по п.1, отличающееся тем, что количество указанного биологически активного вещества составляет примерно от 5 до 15% по массе. ! 6. Имплантируемое медицинское устройство по п.5, отличающееся тем, что количество указанного биологически активного вещества составляет примерно от 8 до 12% по массе. !7.
Claims (15)
1. Имплантируемое медицинское устройство, содержащее:
по меньшей мере один биодеградируемый полимер в количестве примерно 2-99% от массы указанного имплантируемого медицинского устройства;
по меньшей мере одно биологически активное вещество в количестве примерно 1-60% от массы указанного имплантируемого медицинского устройства, причем биологически активное вещество находится в композиции в виде частиц, при этом по меньшей мере 80% частиц имеют размер в интервале от 5 до 50 мкм в диаметре, а указанное биологически активное вещество представляет собой клонидин.
2. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанное имплантируемое медицинское устройство обеспечивает профиль элюирования, при котором менее 80% биологически активного вещества элюируется через 60 дней после того, как имплантируемое медицинское устройство было имплантировано пациенту в физиологических условиях.
3. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанный полимер выбран из группы, включающей сополимер полилактида с гликолидом, полилактид, сложный полиортоэфир, и их комбинации.
4. Имплантируемое медицинское устройство по п.1, отличающееся тем, что указанный полимер имеет аморфную структуру, а биологически активное вещество имеет кристаллическую структуру.
5. Имплантируемое медицинское устройство по п.1, отличающееся тем, что количество указанного биологически активного вещества составляет примерно от 5 до 15% по массе.
6. Имплантируемое медицинское устройство по п.5, отличающееся тем, что количество указанного биологически активного вещества составляет примерно от 8 до 12% по массе.
7. Способ изготовления имплантируемого медицинского устройства, включающий
обеспечение биологически активного вещества в виде порошка, в котором по меньшей мере 80% частиц имеют размер в интервале от 5 до 50 мкм в диаметре;
обеспечение полимера в виде порошка;
объединение порошков биологически активного вещества и полимера с образованием порошковой смеси;
перемешивание в расплаве порошковой смеси с образованием расплава смеси; и
экструдирование расплава смеси с формированием имплантируемого медицинского устройства, в котором биологически активное вещество представляет собой клонидин HCL.
8. Способ по п.7, отличающийся тем, что биологически активное вещество высушивают распылением перед стадией обеспечения в виде порошка, причем распылительная сушка включает стадии:
объединения биологически активного вещества с жидким носителем; и
высушивания распылением объединенных жидкого носителя и биологически активного вещества в условиях, достаточных для получения частиц биологически активного вещества со средним размером в интервале примерно от 5 до 50 мкм в диаметре.
9. Способ доставки биологически активного вещества к ткани, включающий:
размещение медицинского устройства по п.1 вблизи от ткани; и
предоставление медицинскому устройству возможности доставлять биологически активное вещество к ткани.
10. Способ по п.9, отличающийся тем, что указанное медицинское устройство имплантируют в виде стержня вблизи седалищного нерва.
11. Способ по п.9, отличающийся тем, что имплантируют несколько медицинских устройств.
12. Депо лекарственного средства, содержащее
по меньшей мере один биодеградируемый полимер в количестве примерно 80-95% от массы указанного депо лекарственного средства, при этом указанный биодеградируемый полимер выбран из группы, включающей сополимер лактида с гликолидом, полилактид, сложный полиортоэфир, и их комбинации;
клонидин или его производное в количестве примерно 5-20% от массы указанной лекарственной формы депо, при этом клонидин или его производное находится в депо лекарственного средства в виде частиц, и 80% частиц имеют размер в интервале от 10 до 20 мкм в диаметре.
13. Способ получения депо лекарственного средства, включающий
обеспечение клонидина или его производного в виде порошка, в котором по меньшей мере 80% частиц имеют размер в интервале от 10 до 20 мкм в диаметре;
обеспечение полимера в виде порошка, при этом полимер выбирают из группы, включающей сополимер полилактида с гликолидом, полилактид, сложный полиортоэфир, и их комбинации;
объединение порошков клонидина или его производного с указанным полимером с образованием порошковой смеси;
перемешивание в расплаве порошковой смеси с образованием расплава смеси; и
экструдирование расплава смеси с формированием депо лекарственного средства.
14. Способ доставки клонидина или его производного к ткани, включающий:
размещение депо лекарственного средства согласно п.12 вблизи от ткани; и
предоставление депо лекарственного средства возможности доставки клонидина или его производного к ткани.
15. Способ по п.14, отличающийся тем, что клонидин представляет собой клонидин HCl, при этом менее 80% клонидина HCl высвобождается через 100 дней после того, как депо лекарственного средства было размещено вблизи от ткани.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4621308P | 2008-04-18 | 2008-04-18 | |
US61/046,213 | 2008-04-18 | ||
US12/410,151 | 2009-03-24 | ||
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PCT/US2009/040916 WO2009129439A2 (en) | 2008-04-18 | 2009-04-17 | Medical devices and methods including polymers having biologically active agents therein |
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KR20100054844A (ko) | 2010-05-25 |
JP2011508790A (ja) | 2011-03-17 |
WO2009129439A3 (en) | 2010-01-28 |
JP5197763B2 (ja) | 2013-05-15 |
CN103142459A (zh) | 2013-06-12 |
BRPI0904961A2 (pt) | 2015-06-30 |
JP5693623B2 (ja) | 2015-04-01 |
EP3666255A1 (en) | 2020-06-17 |
CN101808620B (zh) | 2013-01-09 |
WO2009129439A2 (en) | 2009-10-22 |
RU2521395C2 (ru) | 2014-06-27 |
US8557273B2 (en) | 2013-10-15 |
WO2009129439A4 (en) | 2010-03-18 |
AU2009236094A1 (en) | 2009-10-22 |
US8999368B2 (en) | 2015-04-07 |
CN103142459B (zh) | 2016-08-03 |
US20130292869A1 (en) | 2013-11-07 |
CN101808620A (zh) | 2010-08-18 |
EP2197419A2 (en) | 2010-06-23 |
JP2013090952A (ja) | 2013-05-16 |
AU2009236094B2 (en) | 2015-06-18 |
EP2197419B1 (en) | 2019-11-20 |
US20090263460A1 (en) | 2009-10-22 |
CA2700561A1 (en) | 2009-10-22 |
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