RU2020132467A - Микроигольная платформа со структурой типа сердцевина-оболочка для трансдермальной и пульсирующей доставки лекарств/вакцин и способ ее изготовления - Google Patents

Микроигольная платформа со структурой типа сердцевина-оболочка для трансдермальной и пульсирующей доставки лекарств/вакцин и способ ее изготовления Download PDF

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RU2020132467A
RU2020132467A RU2020132467A RU2020132467A RU2020132467A RU 2020132467 A RU2020132467 A RU 2020132467A RU 2020132467 A RU2020132467 A RU 2020132467A RU 2020132467 A RU2020132467 A RU 2020132467A RU 2020132467 A RU2020132467 A RU 2020132467A
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microneedle
therapeutic agent
silicone mold
core
copolymer
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RU2020132467A
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Тханх Д. НГУЙЕН
Кханх ТРАН
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Юниверсити Оф Коннектикут
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/20Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205Vaccinating by means of needles or other puncturing devices
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/003Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor characterised by the choice of material
    • B29C39/006Monomers or prepolymers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C39/026Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles characterised by the shape of the surface
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C39/00Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • B29C39/02Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C39/10Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. casting around inserts or for coating articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/003Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor characterised by the choice of material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/003Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor characterised by the choice of material
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/021Compression 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/32Component parts, details or accessories; Auxiliary operations
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/003Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0046Solid microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0053Methods for producing microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0061Methods for using microneedles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles

Claims (31)

1. Система пульсирующей доставки лекарств, содержащая блок микроигл, включающий в себя множество микроигл, заполненных терапевтическим средством, при этом микроиглы содержат биоразлагаемые полимеры, блок микроигл выполнен с возможностью высвобождения терапевтического средства через предварительно заданные временные интервалы в предварительно заданном количестве терапевтического средства, в то время как блок микроигл остается внедренным в пациента.
2. Система по п. 1, в которой биоразлагаемый полимер разрушается с течением времени для высвобождения терапевтического средства в пациента.
3. Система по п. 1, дополнительно содержащая компьютерный процессор, имеющий электронную связь с блоком микроигл, при этом компьютерный процессор запрограммирован компьютерно-читаемыми командами, чтобы инициировать высвобождение терапевтического средства.
4. Система по п. 5, дополнительно содержащая активизатор, имеющий электронную связь с компьютерным процессором, чтобы инициировать высвобождение терапевтического средства.
5. Система по п. 1, в которой терапевтическое средство является вакциной.
6. Способ изготовления блока микроигл, при этом способ содержит следующие этапы:
формируют блок сердцевин микроигл посредством
заполнения первой силиконовой формы, включающей в себя множество микроигольных полостей, сополимером,
вращения первой силиконовой формы для снятия первого избыточного слоя сополимера на первой силиконовой форме, и
формирования сердцевины в каждой из полостей, заполненных сополимером;
формируют блок терапевтического средства посредством
заполнения множества полостей во второй силиконовой форме терапевтическим средством,
вращения второй силиконовой формы для снятия второго избыточного слоя терапевтического средства, и
извлечения формованного терапевтического средства из второй формы и переноса формованного терапевтического средства на подложку; и
совмещают блок терапевтического средства с блоком сердцевин микроигл, чтобы, тем самым, заполнить сердцевины в блоке сердцевин микроигл терапевтическим средством.
7. Способ по п. 6, в котором полости в первой силиконовой форме и второй силиконовой форме имеют коническую форму.
8. Способ по п. 6, в котором сополимер является сополимером D, L-лактида с гликолидом (PLGA).
9. Способ по п. 6, дополнительно содержащий этап формирования первой силиконовой формы посредством налива полидиметилсилоксана (PDMS) на основную структуру и отверждения.
10. Способ по п. 6, дополнительно содержащий этап накапывания растворителя на первый избыточный слой, чтобы снять избыточный слой, с одновременным вращением первой силиконовой формы.
11. Способ по п. 10, в котором растворитель является ацетоном.
12. Способ по п. 6, дополнительно содержащий этап накапывания воды на второй избыточный слой, чтобы снять второй избыточный слой, с одновременным вращением второй силиконовой формы.
13. Способ по п. 6, в котором терапевтическое средство смешано с полимерным носителем из биосовместимых или биоразлагаемых полимеров.
14. Способ по п. 13, в котором полимерный носитель является поливинилпирролидоном (PVP).
15. Способ по п. 6, дополнительно содержащий этап формирования блока крышек посредством
заполнения множества полостей в третьей силиконовой форме сополимером, чтобы сформировать множество крышек,
вращения третьей силиконовой формы, чтобы снять избыточный слой сополимера на третьей силиконовой форме,
снятия формованных крышек с третьей формы и переноса формованных крышек на блок сердцевин микроигл, и
совмещения блока крышек с блоком сердцевин микроигл, чтобы тем самым закрыть сердцевины в блоке сердцевин микроигл крышками.
16. Способ по п. 15, дополнительно содержащий этап подведения тепла для приклеивания блока крышек к блоку сердцевин микроигл.
17. Способ по п. 15, дополнительно содержащий этап нанесения на опорную матрицу покрытия из водорастворимого полимера и приведения опорной матрицы в контакт с блоком крышек.
18. Способ по п. 17, дополнительно содержащий этап подведения тепла, чтобы приклеить опорную матрицу к блоку крышек для извлечения блока микроигл из первой силиконовой формы.
RU2020132467A 2018-03-05 2019-03-05 Микроигольная платформа со структурой типа сердцевина-оболочка для трансдермальной и пульсирующей доставки лекарств/вакцин и способ ее изготовления RU2020132467A (ru)

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US201862638758P 2018-03-05 2018-03-05
US62/638,758 2018-03-05
PCT/US2019/020838 WO2019173402A1 (en) 2018-03-05 2019-03-05 Core-shell microneedle platform for transdermal and pulsatile drug/vaccine delivery and method of manufacturing the same

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US (2) US11426570B2 (ru)
EP (1) EP3761864A4 (ru)
CN (1) CN112074227A (ru)
RU (1) RU2020132467A (ru)
WO (1) WO2019173402A1 (ru)

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