RU2015143540A - Микрочип для доставки лекарственного средства и способы его использования - Google Patents
Микрочип для доставки лекарственного средства и способы его использования Download PDFInfo
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- 238000000034 method Methods 0.000 title claims 2
- 229940126601 medicinal product Drugs 0.000 title 1
- 229920000642 polymer Polymers 0.000 claims 46
- 239000011159 matrix material Substances 0.000 claims 31
- 239000003814 drug Substances 0.000 claims 30
- 229940079593 drug Drugs 0.000 claims 29
- 239000000758 substrate Substances 0.000 claims 15
- 239000000853 adhesive Substances 0.000 claims 10
- 230000001070 adhesive effect Effects 0.000 claims 10
- 239000011248 coating agent Substances 0.000 claims 8
- 238000000576 coating method Methods 0.000 claims 8
- 239000003292 glue Substances 0.000 claims 7
- 229920002988 biodegradable polymer Polymers 0.000 claims 6
- 239000004621 biodegradable polymer Substances 0.000 claims 6
- 229920006158 high molecular weight polymer Polymers 0.000 claims 6
- 239000000725 suspension Substances 0.000 claims 6
- 210000003491 skin Anatomy 0.000 claims 5
- 238000005266 casting Methods 0.000 claims 4
- 229920003177 water-insoluble biodegradable polymer Polymers 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- 229920001651 Cyanoacrylate Polymers 0.000 claims 2
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims 2
- MWCLLHOVUTZFKS-UHFFFAOYSA-N Methyl cyanoacrylate Chemical compound COC(=O)C(=C)C#N MWCLLHOVUTZFKS-UHFFFAOYSA-N 0.000 claims 2
- 229920000954 Polyglycolide Polymers 0.000 claims 2
- 229920001577 copolymer Polymers 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 2
- 230000037368 penetrate the skin Effects 0.000 claims 2
- 229920000747 poly(lactic acid) Polymers 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 210000000434 stratum corneum Anatomy 0.000 claims 2
- 239000003106 tissue adhesive Substances 0.000 claims 2
- 108010080379 Fibrin Tissue Adhesive Proteins 0.000 claims 1
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims 1
- 239000003522 acrylic cement Substances 0.000 claims 1
- 238000004026 adhesive bonding Methods 0.000 claims 1
- 230000000975 bioactive effect Effects 0.000 claims 1
- JJJFUHOGVZWXNQ-UHFFFAOYSA-N enbucrilate Chemical group CCCCOC(=O)C(=C)C#N JJJFUHOGVZWXNQ-UHFFFAOYSA-N 0.000 claims 1
- 229950010048 enbucrilate Drugs 0.000 claims 1
- 239000000017 hydrogel Substances 0.000 claims 1
- QRWOVIRDHQJFDB-UHFFFAOYSA-N isobutyl cyanoacrylate Chemical compound CC(C)COC(=O)C(=C)C#N QRWOVIRDHQJFDB-UHFFFAOYSA-N 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 230000035515 penetration Effects 0.000 claims 1
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims 1
- 229920001296 polysiloxane Polymers 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 150000003384 small molecules Chemical class 0.000 claims 1
- 239000003894 surgical glue Substances 0.000 claims 1
- 229960005486 vaccine Drugs 0.000 claims 1
- 229920003176 water-insoluble polymer Polymers 0.000 claims 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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Claims (95)
1. Микроструктурный аппарат, включающий
практически плоскостную подложку, имеющую первую поверхность и вторую поверхность, противолежащую ей; и
микроструктурный чип, включающий множество элементов микроструктуры, находящихся в контакте с первой поверхностью подложки и неподвижно прикрепленных к ней, при этом элементы микроструктуры получают из полимерной матрицы, содержащей (i) не растворимый в воде, биоразлагаемый полимер и (ii) по меньшей мере, одно лекарственное средство;
где высвобождение лекарственного средства из полимерной матрицы является замедленным в течение периода времени, составляющего, по меньшей мере, приблизительно 1-144 ч.
2. Микроструктурный аппарат по п. 1, где не растворимый в воде полимер выбирают из полилактида, полигликолида и их сополимеров.
3. Микроструктурный аппарат, включающий
практически плоскостную подложку, имеющую первую поверхность и вторую поверхность, противолежащую ей; и
микроструктурный чип, включающий множество элементов микроструктуры, находящихся в контакте с первой поверхностью подложки и неподвижно прикрепленных к ней, при этом элементы микроструктуры получают из полимерной матрицы, содержащей (i) по меньшей мере, один низкомолекулярный полимер, (ii) по меньшей мере, один высокомолекулярный полимер и (iii) по меньшей мере, одно лекарственное средство;
где скорость начального высвобождения лекарственного средства из полимерной матрицы находится в диапазоне приблизительно 0,05-10%/минута;
где высвобождение лекарственного средства из полимерной матрицы является замедленным в течение периода времени, составляющего, по меньшей мере, приблизительно 1-144 часа.
4. Аппарат по п. 3, где полимерная матрица содержит, по меньшей мере, один не растворимый в воде, биоразлагаемый полимер.
5. Аппарат по п. 3, где
низкомолекулярный полимер имеет молекулярную массу в диапазоне приблизительно 1-10000 Да,
высокомолекулярный полимер имеет молекулярную массу в диапазоне приблизительно 50-300000 Да, или
где высокомолекулярный полимер имеет молекулярную массу в диапазоне приблизительно 50-70000 Да.
6. Аппарат по п. 3, где
низкомолекулярный полимер и высокомолекулярные полимеры присутствуют при соотношении в диапазоне приблизительно 1:1-1:10,
низкомолекулярный полимер и высокомолекулярные полимеры присутствуют при соотношении, составляющем приблизительно 1:1, или
низкомолекулярный полимер и высокомолекулярные полимеры присутствуют при соотношении, составляющем приблизительно 1:4.
7. Микроструктурный аппарат, включающий
практически плоскостную подложку, имеющую первую поверхность и вторую поверхность, противолежащую ей; и
микроструктурный чип, включающий множество элементов микроструктуры, находящихся в контакте с первой поверхностью подложки и неподвижно прикрепленных к ней, при этом элементы микроструктуры получают из полимерной матрицы, содержащей (i) по меньшей мере один биоразлагаемый полимер, (ii) гидрофильный компонент и (iii) по меньшей мере одно лекарственное средство;
где высвобождение лекарственного средства из полимерной матрицы является замедленным в течение периода времени, составляющего, по меньшей мере, приблизительно 1-144 ч.
8. Аппарат по п. 7, где
полимерная матрица содержит приблизительно 5-40% гидрофильного компонента;
полимерная матрица содержит приблизительно 5-10% гидрофильного компонента;
полимерная матрица содержит приблизительно 5-40% гидрофильного компонента;
полимерная матрица содержит вплоть до приблизительно 40% гидрофильного компонента;
полимерная матрица содержит вплоть до приблизительно 20% гидрофильного компонента;
полимерная матрица содержит вплоть до приблизительно 10% гидрофильного компонента.
9. Аппарат по п. 1, где гидрофильный компонент представляет собой полимер PEG-PLGA.
10. Микроструктурный аппарат, включающий:
практически плоскостную подложку, имеющую первую поверхность и вторую поверхность, противолежащую ей;
микроструктурный чип, включающий множество элементов микроструктуры, находящихся в контакте с первой поверхностью подложки и неподвижно прикрепленных к ней, при этом элементы микроструктуры получают из полимерной матрицы, содержащей по меньшей мере один полимер и по меньшей мере одно лекарственное средство;
где соотношение между лекарственным средством и полимером в матрице является низким;
где скорость начального высвобождения лекарственного средства из полимерной матрицы находится в диапазоне приблизительно 0,05-10%/мин;
где высвобождение лекарственного средства из полимерной матрицы является замедленным в течение периода времени, составляющего, по меньшей мере, приблизительно 1-144 ч.
11. Аппарат по п. 10, где
соотношение между лекарственным средством и полимером находится в диапазоне приблизительно от 1:2 до 1:25;
соотношение между лекарственным средством и полимером находится в диапазоне приблизительно от 1:2 до 1:20;
соотношение между лекарственным средством и полимером находится в диапазоне приблизительно от 1:2 до 1:15;
соотношение между лекарственным средством и полимером находится в диапазоне приблизительно от 1:2 до 1:10; или
соотношение между лекарственным средством и полимером находится в диапазоне приблизительно от 1:2 до 1:4.
12. Аппарат по п. 3, п. 7 или п. 10, где полимерная матрица содержит по меньшей мере один не растворимый в воде,
биоразлагаемый полимер.
13. Аппарат по п. 12, где не растворимый в воде, биоразлагаемый полимер выбирают из полилактида, полигликолида и их сополимеров.
14. Микроструктурный аппарат по любому из пп. 1, 3, 7 или 10, где полимерная матрица содержит приблизительно 1-50% лекарственного средства или приблизительно 10-50% лекарственного средства или приблизительно 20-50% лекарственного средства или приблизительно 25-50% лекарственного средства или приблизительно 30-50% лекарственного средства или приблизительно 45-50% лекарственного средства.
15. Микроструктурный аппарат по п. 1, где полимерная матрица содержит приблизительно 50-99% или приблизительно 50-90% не растворимого в воде биоразлагаемого полимера.
16. Микроструктурный аппарат по п. 12, где
полимерная матрица содержит приблизительно 50-99% не растворимого в воде биоразлагаемого полимера, или
полимерная матрица содержит приблизительно 50-90% не растворимого в воде биоразлагаемого полимера.
17. Микроструктурный аппарат по любому из пп. 1, 3, 7 или 10, где скорость начального высвобождения лекарственного средства из полимерной матрицы выбирают из диапазона приблизительно 0,05-10%/мин, диапазона приблизительно 0,5-10%/мин, диапазона приблизительно 1-10%/мин и диапазона приблизительно 2-10%/мин.
18. Аппарат по любому из пп. 1, 3, 7 или 10, где высвобождение лекарственного средства из полимерной матрицы является замедленным в течение периода времени, выбираемого из, по меньшей мере, приблизительно 144 ч, по меньшей мере, приблизительно 72 ч, по меньшей мере, приблизительно 24 ч, по меньшей мере, приблизительно 12 ч, по меньшей мере, приблизительно 6 часов, по меньшей мере, приблизительно 3 ч и, по меньшей мере, приблизительно 1 ч.
19. Аппарат по любому из пп. 1, 3, 7 или 10, где по меньшей мере часть элементов микроструктуры является отделяемой от подложки.
20. Аппарат по любому из пп. 1, 3, 7 или 10, где лекарственное средство выбирают из лекарственного препарата, небольшой молекулы, пептида или белка или вакцины.
21. Аппарат по любому из пп. 1, 3, 7 или 10, кроме того, включающий
адгезивное покрытие, нанесенное на по меньшей мере одного представителя, выбираемого из а) по меньшей мере, части по меньшей мере некоторых из множества элементов микроструктуры, b) по меньшей мере, части первой поверхности подложки между элементами микроструктуры, и с) по меньшей мере, части второй поверхности подложки.
22. Аппарат по п. 21, где адгезивное покрытие включает
клей, выбранный из медицинского клея, тканевого клея и/или хирургического клей,
где медицинский клей выбирают из акрилового клея, клея на силиконовой основе, гидрогелевого клея и синтетического эластомерного клея,
где тканевый клей на основе цианоакрилатного полимера;
где цианоакрилатный полимер выбирают из н-бутил-2-цианоакрилата и изобутилцианоакрилата;
фибриновый герметик;
биоактивную пленку;
клей, склеивающий при надавливании;
акриловый клей, склеивающий при надавливании; или
клей на каучуковой основе.
23. Аппарат по п. 21, где
адгезивное покрытие является биоразлагаемым,
адгезивное покрытие является ненепрерывным,
адгезивное покрытие включает множество просветов,
адгезивное покрытие является пористым,
адгезионной покрытие имеет уменьшение адгезии с течением времени.
24. Аппарат по п. 21, дополнительно, включающий
множество отверстий, проходящих через подложку и располагающихся между по меньшей мере некоторыми из множества элементов микроструктуры; и
адгезивное покрытие, нанесенное на по меньшей мере часть второй поверхности подложки таким образом, чтобы адгезив был бы способен вступать в контакт с кожей пациента через отверстия при размещении на коже.
25. Аппарат по любому из пп. 1, 3, 7 или 10, где по меньшей мере часть элементов микроструктуры имеет дистальную часть, полученную из полимерной матрицы, которая имеет размеры для проникновения в роговой слой кожи пациента, и проксимальную часть, которая имеет такие размеры, что она не проникает в кожу пациента.
26. Микроструктурный аппарат, включающий
практически плоскостную подложку, имеющую первую поверхность и вторую поверхность, противолежащую ей; и
микроструктурный чип, включающий множество элементов микроструктуры, находящихся в контакте с первой поверхностью подложки и неподвижно прикрепленных к ней;
где по меньшей мере часть элементов микроструктуры имеет дистальную часть, имеющую размеры для проникновения в роговой слой кожи пациента, и проксимальную часть, которая имеет такие размеры, что она не проникает в кожу;
где каждую часть, выбираемую из дистальной части и проксимальной части, получают из полимерной матрицы, содержащей (i) биоразлагаемый полимер и (ii) по меньшей мере, одно лекарственное средство.
27. Система, включающая
микроструктурный аппарат по любому одному из пп. 1, 3, 7, 10 или 26; и
аппликатор для нанесения микроструктурного аппарата на кожу пациента.
28. Способ получения микроструктурного аппарата с замедленным высвобождением, включающий
растворение или суспендирование лекарственного средства в растворителе для получения раствора или суспензии лекарственного средства;
растворение по меньшей мере одного не растворимого в воде, биоразлагаемого полимера в растворителе для получения раствора
полимера;
перемешивание раствора или суспензии лекарственного средства и раствора или суспензии полимера для получения раствора или суспензии полимерной матрицы;
дозирование раствора или суспензии полимерной матрицы на форму для отливки, включающую чип, имеющий полости элементов микроструктуры;
заполнение полостей элементов микроструктуры в форме для отливки;
удаление избыточной полимерной матрицы раствора или суспензии на поверхности формы для отливки; и высушивание матрицы для получения множества элементов микроструктуры;
дозирование слоя основания или опоры на поверхность формы для отливки;
высушивание слоя основания или опоры.
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PCT/US2014/026179 WO2014151654A1 (en) | 2013-03-15 | 2014-03-13 | Microarray for delivery of therapeutic agent and methods of use |
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CA2903459C (en) | 2013-03-15 | 2024-02-20 | Corium International, Inc. | Multiple impact microprojection applicators and methods of use |
CN105744983B (zh) | 2013-08-12 | 2019-12-27 | 纳米医学***公司 | 用于缓释在增溶剂中的低水溶性治疗剂的装置和方法 |
CA2981974C (en) | 2014-04-24 | 2023-06-20 | Georgia Tech Research Corporation | Microneedles and methods of manufacture thereof |
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US10792857B2 (en) | 2015-03-13 | 2020-10-06 | The University Of North Carolina At Chapel Hill | Polymeric microneedles and rapid additive manufacturing of the same |
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RU2701361C1 (ru) | 2015-12-28 | 2019-09-27 | Эндодерма Ко., Лтд. | Микроструктура для трансдермального введения и способ её получения |
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ZA201506984B (en) | 2016-12-21 |
US20190336741A1 (en) | 2019-11-07 |
JP6700170B2 (ja) | 2020-05-27 |
KR20150130391A (ko) | 2015-11-23 |
AU2020256382B2 (en) | 2022-09-01 |
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CA2906541A1 (en) | 2014-09-25 |
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BR112015022625B1 (pt) | 2023-01-31 |
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AU2014233695A1 (en) | 2015-10-01 |
ES2908339T3 (es) | 2022-04-28 |
CA2906541C (en) | 2022-06-21 |
CN105246458A (zh) | 2016-01-13 |
JP2020094067A (ja) | 2020-06-18 |
EP2968118A1 (en) | 2016-01-20 |
KR102341601B1 (ko) | 2021-12-21 |
BR112015022625A2 (pt) | 2017-07-18 |
AU2020256382C1 (en) | 2022-12-01 |
JP2018141023A (ja) | 2018-09-13 |
US20230134250A1 (en) | 2023-05-04 |
EP2968118B1 (en) | 2022-02-09 |
JP2016513649A (ja) | 2016-05-16 |
AU2019201233A1 (en) | 2019-03-14 |
AU2020256382A1 (en) | 2020-11-12 |
US10384046B2 (en) | 2019-08-20 |
US11565097B2 (en) | 2023-01-31 |
CN105246458B (zh) | 2020-09-15 |
WO2014151654A1 (en) | 2014-09-25 |
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