RU2015129771A - Микроматрица для доставки терапевтического средства и способы использования - Google Patents
Микроматрица для доставки терапевтического средства и способы использования Download PDFInfo
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- RU2015129771A RU2015129771A RU2015129771A RU2015129771A RU2015129771A RU 2015129771 A RU2015129771 A RU 2015129771A RU 2015129771 A RU2015129771 A RU 2015129771A RU 2015129771 A RU2015129771 A RU 2015129771A RU 2015129771 A RU2015129771 A RU 2015129771A
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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
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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
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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
- A61K9/0012—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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/021—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles characterised by the shape of the surface
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
- B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
- B29C70/78—Moulding material on one side only of the preformed part
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B81—MICROSTRUCTURAL TECHNOLOGY
- B81C—PROCESSES OR APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OR TREATMENT OF MICROSTRUCTURAL DEVICES OR SYSTEMS
- B81C1/00—Manufacture or treatment of devices or systems in or on a substrate
- B81C1/00349—Creating layers of material on a substrate
- B81C1/00357—Creating layers of material on a substrate involving bonding one or several substrates on a non-temporary support, e.g. another substrate
-
- 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
- A61M2037/0046—Solid microneedles
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
- B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
- B29C43/021—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles characterised by the shape of the surface
- B29C2043/023—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles characterised by the shape of the surface having a plurality of grooves
- B29C2043/025—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles characterised by the shape of the surface having a plurality of grooves forming a microstructure, i.e. fine patterning
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- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Medicinal Chemistry (AREA)
- Mechanical Engineering (AREA)
- Hematology (AREA)
- Medical Informatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Anesthesiology (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Composite Materials (AREA)
- Manufacturing & Machinery (AREA)
- Microelectronics & Electronic Packaging (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Claims (48)
1. Микроструктурный аппарат, содержащий:
задник, который имеет первую поверхность и вторую поверхность, противоположную ей;
матрицу микроструктур, которая содержит множество микроструктур, проходящих наружу от первой поверхности задника;
микроструктуры, которые содержат биоразрушаемый дистальный слой и по меньшей мере один проксимальный слой, расположенный между дистальным слоем и первой поверхностью задника;
дистальный слой, состоящий из по меньшей мере одного терапевтического средства и по меньшей мере одного полимера (i) выбранного из (a) гидрофобного полимера и (b) полимера с температурой стеклования, равной приблизительно 20-25°C или выше нее; или (ii) в концентрации в полимерном литейном растворе, используемом для формирования дистального слоя микроструктур, которая равна его концентрации переплетения (CE) или ниже ее, причем выбор полимера является таким, что по меньшей мере часть дистального слоя открепляется от микроструктур, когда матрицу вставляют в кожу.
2. Микроструктурный аппарат по п. 1, в котором по меньшей мере один полимер дистального слоя содержит по меньшей мере один гидрофобный полимер и приблизительно 0-99% по меньшей мере одного гидрофильного полимера.
3. Микроструктурный аппарат по п. 1, в котором по меньшей мере один полимер дистального слоя содержит по меньшей мере один гидрофобный полимер и приблизительно 0-50% гидрофильного полимера.
4. Микроструктурный аппарат по п. 1, в котором по меньшей мере один полимер дистального слоя содержит по меньшей мере один гидрофобный полимер и приблизительно 0-20% гидрофильного полимера.
5. Микроструктурный аппарат по п. 1, в котором по меньшей мере одно терапевтическое средство представляет собой низкомолекулярное лекарственное средство, по меньшей мере частично растворимое с по меньшей мере одним полимером в растворителе или сорастворителе.
6. Микроструктурный аппарат по п. 5, в котором дистальный слой содержит приблизительно 1-99% низкомолекулярного лекарственного средства.
7. Микроструктурный аппарат по п. 5, в котором дистальный слой содержит приблизительно 1-50% низкомолекулярного лекарственного средства.
8. Микроструктурный аппарат по п. 5, в котором дистальный слой содержит приблизительно 6-40% низкомолекулярного лекарственного средства.
9. Микроструктурный аппарат по п. 5, в котором дистальный слой содержит приблизительно 10-30% низкомолекулярного лекарственного средства.
10. Микроструктурный аппарат по п. 1, в котором по меньшей мере одно терапевтическое средство диспергируют в дистальном слое.
11. Микроструктурный аппарат по п. 10, в котором дистальный слой содержит приблизительно 1-90% диспергированного средства.
12. Микроструктурный аппарат по п. 10, в котором дистальный слой содержит приблизительно 1-50% диспергированного средства.
13. Микроструктурный аппарат по п. 10, в котором дистальный слой содержит приблизительно 10-40% диспергированного средства.
14. Микроструктурный аппарат по п. 10, в котором дистальный слой содержит приблизительно 20-30% диспергированного средства.
15. Микроструктурный аппарат по п. 1, в котором по меньшей мере один полимер имеет температуру стеклования (Tg) выше приблизительно температуры тела.
16. Микроструктурный аппарат по п. 1, в котором приблизительно по меньшей мере 10% дистального слоя легко открепляется, когда матрицу вставляют в кожу.
17. Микроструктурный аппарат по п. 1, в котором приблизительно по меньшей мере 50% дистального слоя легко открепляется, когда матрицу вставляют в кожу.
18. Микроструктурный аппарат по п. 1, в котором приблизительно по меньшей мере 70% дистального слоя легко открепляется, когда матрицу вставляют в кожу.
19. Микроструктурный аппарат по п. 1, в котором приблизительно по меньшей мере 90% дистального слоя легко открепляется, когда матрицу вставляют в кожу.
20. Микроструктурный аппарат по п. 1, в котором приблизительно 100% дистального слоя легко открепляется, когда матрицу вставляют в кожу.
21. Микроструктурный аппарат по п. 1, в котором по меньшей мере часть микроструктур имеет первый диаметр в поперечных размерах, который больше, чем второй диаметр в поперечных размерах.
22. Микроструктурный аппарат по п. 21, в котором по меньшей мере часть микроструктур имеет геометрическую форму в поперечных размерах, выбранную из группы, состоящей из ромба, прямоугольника и овала.
23. Микроструктурный аппарат по п. 21 или 22, в котором по меньшей мере часть микроструктур имеет асимметричную геометрическую форму поперечных размеров.
24. Микроструктурный аппарат по п. 1, в котором концентрация по меньшей мере одного полимера в полимерном литейном растворе, используемом для формирования микроструктуры, равна CE для этого полимера.
25. Микроструктурный аппарат по п. 1, в котором по меньшей мере часть проксимального и/или дистального слоев имеет воронкообразную форму.
26. Микроструктурный аппарат по п. 1, в котором микроструктуру прикрепляют к первой поверхности задника.
27. Микроструктурный аппарат по п. 1, в котором по меньшей мере часть задника образует проксимальный слой.
28. Микроструктурный аппарат по п. 1, дополнительно содержащий подложку, которая имеет первую поверхность и вторую поверхность, противоположную ей, причем вторую поверхность задника прикреплена к первой поверхности подложки.
29. Микроструктурный аппарат по п. 1, в котором дистальный слой состоит по меньшей мере из одного полимера и приблизительно 1-90% по меньшей мере одного терапевтического средства.
30. Микроструктурный аппарат по п. 1, в котором по меньшей мере один из по меньшей мере одного полимера имеет молекулярную массу приблизительно между 1-100 кДа.
31. Микроструктурный аппарат по п. 21, в котором дистальный слой имеет первый диаметр в поперечных размерах, больший, чем второй диаметр в поперечных размерах.
32. Способ получения микроструктурного аппарата, включающий в себя этапы, на которых:
растворяют или суспендируют терапевтическое средство в растворителе для формирования раствора или суспензии терапевтического средства;
растворяют, по меньшей мере, один полимер в растворителе для формирования полимерного раствора, в котором полимер (i) выбирают из (a) гидрофобного полимера и (b) полимера с температурой стеклования, равной приблизительно 20-25°C или выше нее; или (ii) в концентрации в полимерном литейном растворе, используемом для формирования дистального слоя микроструктуры, которая равна его концентрации переплетения (CE) или ниже нее;
смешивают раствор или суспензию терапевтического средства и полимерного раствора или суспензии для формирования раствора или суспензии полимерной матрицы;
распределяют раствор или суспензию полимерной матрицы на форму, которая имеет набор полостей микроструктур; после чего следует повышение давления;
удаляют избыток раствора или суспензии полимерной матрицы на поверхности формы; и сушат матрицу; и
распределяют подстилающей или поддерживающий слой на поверхности формы; и
сушат подстилающий или поддерживающий слой;
причем полимер выбирают так, что, по меньшей мере, часть дистального слоя открепляется от микроструктур при вставлении микроструктурного аппарата.
33. Способ по п. 32, дополнительно включающий этап, на котором:
прикрепляют подстилающий или поддерживающий слой к подложке.
34. Способ по п. 33, дополнительно включающий этап, на котором:
применяют нетканую или пористую пленку с двойным покрытием адгезивом для прикрепления подстилающего или поддерживающего слоя к подложке.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261745513P | 2012-12-21 | 2012-12-21 | |
| US61/745,513 | 2012-12-21 | ||
| PCT/US2013/077281 WO2014100750A1 (en) | 2012-12-21 | 2013-12-20 | Microarray for delivery of therapeutic agent and methods of use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2015129771A true RU2015129771A (ru) | 2017-01-30 |
| RU2698095C2 RU2698095C2 (ru) | 2019-08-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2015129771A RU2698095C2 (ru) | 2012-12-21 | 2013-12-20 | Микроматрица для доставки терапевтического средства и способы использования |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US11052231B2 (ru) |
| EP (1) | EP2934660B1 (ru) |
| JP (3) | JP6865524B2 (ru) |
| KR (1) | KR102265808B1 (ru) |
| CN (1) | CN105073178B (ru) |
| AU (1) | AU2013364053B2 (ru) |
| BR (1) | BR112015014969B1 (ru) |
| CA (1) | CA2896188C (ru) |
| ES (1) | ES2743404T3 (ru) |
| IL (1) | IL239557B (ru) |
| MX (1) | MX2015008157A (ru) |
| RU (1) | RU2698095C2 (ru) |
| WO (1) | WO2014100750A1 (ru) |
Families Citing this family (49)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008130587A2 (en) | 2007-04-16 | 2008-10-30 | Corium International, Inc. | Solvent-cast microneedle arrays containing active |
| WO2009048607A1 (en) | 2007-10-10 | 2009-04-16 | Corium International, Inc. | Vaccine delivery via microneedle arrays |
| CA2798145C (en) | 2010-05-04 | 2022-10-18 | Corium International, Inc. | Method and device for transdermal delivery of parathyroid hormone using a microprojection array |
| MX2015008157A (es) | 2012-12-21 | 2016-02-22 | Corium Int Inc | Microarreglo para la entrega de agente terapeutico y metodos de uso. |
| ES2921481T3 (es) | 2013-03-12 | 2022-08-26 | Corium Inc | Aplicadores para microproyecciones |
| US10384045B2 (en) | 2013-03-15 | 2019-08-20 | Corium, Inc. | Microarray with polymer-free microstructures, methods of making, and methods of use |
| AU2014233695A1 (en) | 2013-03-15 | 2015-10-01 | Corium International, Inc. | Microarray for delivery of therapeutic agent and methods of use |
| US10195409B2 (en) | 2013-03-15 | 2019-02-05 | Corium International, Inc. | Multiple impact microprojection applicators and methods of use |
| CA2903583C (en) | 2013-03-15 | 2021-12-28 | Corium International, Inc. | Microarray for delivery of therapeutic agent, methods of use, and methods of making |
| WO2014204176A1 (ko) * | 2013-06-17 | 2014-12-24 | 연세대학교 산학협력단 | 무고통 및 무패치의 슈팅 마이크로구조체 |
| EP3193828B8 (en) * | 2014-08-29 | 2023-04-05 | Corium Pharma Solutions, Inc. | Microstructure array for delivery of active agents |
| EP3188714A1 (en) * | 2014-09-04 | 2017-07-12 | Corium International, Inc. | Microstructure array, methods of making, and methods of use |
| JP6906885B2 (ja) * | 2014-11-14 | 2021-07-21 | ロレアル | しわを減少させるためのマイクロニードルシート |
| KR102203633B1 (ko) * | 2015-04-14 | 2021-01-15 | 주식회사 엘지생활건강 | 칼슘채널 차단제 전달용 용해성 미세바늘 |
| EP3284506B1 (en) * | 2015-04-13 | 2021-04-28 | LG Household & Health Care Ltd. | Soluble microneedle containing ingredient for controlling release of neurotransmitters |
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2013
- 2013-12-20 MX MX2015008157A patent/MX2015008157A/es active IP Right Grant
- 2013-12-20 ES ES13818960T patent/ES2743404T3/es active Active
- 2013-12-20 RU RU2015129771A patent/RU2698095C2/ru active
- 2013-12-20 US US14/137,899 patent/US11052231B2/en active Active
- 2013-12-20 JP JP2015549839A patent/JP6865524B2/ja active Active
- 2013-12-20 CN CN201380073512.4A patent/CN105073178B/zh active Active
- 2013-12-20 WO PCT/US2013/077281 patent/WO2014100750A1/en active Application Filing
- 2013-12-20 CA CA2896188A patent/CA2896188C/en active Active
- 2013-12-20 AU AU2013364053A patent/AU2013364053B2/en active Active
- 2013-12-20 BR BR112015014969-3A patent/BR112015014969B1/pt active IP Right Grant
- 2013-12-20 EP EP13818960.0A patent/EP2934660B1/en active Active
- 2013-12-20 KR KR1020157019673A patent/KR102265808B1/ko active IP Right Grant
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2015
- 2015-06-21 IL IL239557A patent/IL239557B/en unknown
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2018
- 2018-11-06 JP JP2018208785A patent/JP2019048107A/ja active Pending
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2020
- 2020-11-25 JP JP2020194902A patent/JP2021041208A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| AU2013364053B2 (en) | 2018-08-30 |
| EP2934660B1 (en) | 2019-07-17 |
| US20140180201A1 (en) | 2014-06-26 |
| WO2014100750A1 (en) | 2014-06-26 |
| AU2013364053A1 (en) | 2015-07-16 |
| BR112015014969B1 (pt) | 2021-12-07 |
| JP6865524B2 (ja) | 2021-04-28 |
| ES2743404T3 (es) | 2020-02-19 |
| CA2896188C (en) | 2021-02-23 |
| BR112015014969A2 (pt) | 2017-07-11 |
| EP2934660A1 (en) | 2015-10-28 |
| US11052231B2 (en) | 2021-07-06 |
| CN105073178B (zh) | 2019-07-30 |
| JP2021041208A (ja) | 2021-03-18 |
| RU2698095C2 (ru) | 2019-08-22 |
| KR102265808B1 (ko) | 2021-06-16 |
| CN105073178A (zh) | 2015-11-18 |
| IL239557A0 (en) | 2015-08-31 |
| JP2016511014A (ja) | 2016-04-14 |
| JP2019048107A (ja) | 2019-03-28 |
| CA2896188A1 (en) | 2014-06-26 |
| MX2015008157A (es) | 2016-02-22 |
| KR20150100807A (ko) | 2015-09-02 |
| IL239557B (en) | 2022-01-01 |
| WO2014100750A9 (en) | 2014-12-11 |
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