RU2015139934A - Устройства для доставки лекарственных средств с проницаемым для лекарственного средства компонентом и способы доставки лекарственных средств - Google Patents

Устройства для доставки лекарственных средств с проницаемым для лекарственного средства компонентом и способы доставки лекарственных средств Download PDF

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RU2015139934A
RU2015139934A RU2015139934A RU2015139934A RU2015139934A RU 2015139934 A RU2015139934 A RU 2015139934A RU 2015139934 A RU2015139934 A RU 2015139934A RU 2015139934 A RU2015139934 A RU 2015139934A RU 2015139934 A RU2015139934 A RU 2015139934A
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drug
wall structure
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patient
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Хэцзинь Ли
Карен Дениэл
Мэттью СЭНСОУН
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ТАРИС Биомедикал ЛЛК
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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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
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    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
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    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • AHUMAN NECESSITIES
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    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/438The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
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    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
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    • A61K31/555Heterocyclic compounds containing heavy metals, e.g. hemin, hematin, melarsoprol
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
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    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
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    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0034Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
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    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/007Injectors for solid bodies, e.g. suppositories
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • AHUMAN NECESSITIES
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    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/04General characteristics of the apparatus implanted
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1078Urinary tract
    • A61M2210/1085Bladder

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Claims (35)

1. Имплантируемое устройство для доставки лекарственных средств, содержащее:
корпус, содержащий закрытую полость резервуара для лекарственного средства, ограниченную первой стеночной конструкцией и гидрофильной второй стеночной конструкцией, и
лекарственное средство, содержащееся в полости резервуара для лекарственного средства,
причем первая стеночная конструкция выполнена непроницаемой для лекарственного средства, а вторая стеночная конструкция выполнена проницаемой для лекарственного средства, при этом
(i) первая стеночная конструкция представляет собой цилиндрическую трубку, а вторая стеночная конструкция представляет собой торцевую стенку, размещенную по меньшей мере на одном конце цилиндрической трубки, или
(ii) первая стеночная конструкция и вторая стеночная конструкция примыкают друг к другу и совместно образуют цилиндрическую трубку.
2. Устройство по п. 1, которое выполнено с возможностью введения внутрь мочевого пузыря и с возможностью удержания в нем.
3. Устройство по п. 2, которое выполнено с возможностью упругой деформации между относительно выпрямленной формой, подходящей для введения через уретру пациента и в мочевой пузырь пациента, и формой удержания, подходящей для удержания указанного устройства внутри мочевого пузыря.
4. Устройство по п. 3, дополнительно содержащее полость для удерживающего каркаса и удерживающий каркас, размещенный в указанной полости.
5. Устройство по п. 1, в котором первая стеночная конструкция содержит силикон.
6. Устройство по п. 1, в котором вторая стеночная конструкция содержит термопластичный полиуретан.
7. Устройство по п. 1, в котором первая стеночная конструкция выполнена в виде цилиндрической трубки, а вторая стеночная конструкция представляет собой торцевую стенку, размещенную по меньшей мере на одном конце цилиндрической трубки, и выполнена в виде диска, закрепленного в полости цилиндрической трубки.
8. Устройство по п. 7, в котором диск размещен между внутренней кольцевой прокладкой и внешней кольцевой прокладкой.
9. Устройство по п. 1, в котором первая стеночная конструкция и вторая стеночная конструкция примыкают друг к другу и совместно образуют цилиндрическую трубку, причем первая и вторая стеночные конструкции сформированы в процессе совместной экструзии.
10. Устройство по п. 1, в котором лекарственное средство выполнено в виде одной или большего количества твердотельных единиц лекарственного средства.
11. Устройство по п. 1, в котором лекарственное средство представляет собой лекарственное средство с низкой растворимостью.
12. Устройство по п. 1, в котором лекарственное средство представляет собой лекарственное средство с высокой растворимостью.
13. Устройство по п. 1, в котором лекарственное средство содержит лидокаин, гемцитабин, доцетаксел, карбоплатин, цисплатин, оксалиплатин, троспий, толтеродин, оксибутинин или митомицин C.
14. Способ обеспечения управляемого высвобождения лекарственного средства в пациента, согласно которому:
развертывают устройство для доставки лекарственных средств в теле пациента, причем указанное устройство содержит закрытую полость резервуара для лекарственного средства, ограниченную первой стеночной конструкцией и гидрофильной второй стеночной конструкцией, и
высвобождают лекарственное средство из полости резервуара для лекарственного средства путем проникания через вторую стеночную конструкцию,
причем первая стеночная конструкция выполнена непроницаемой для лекарственного средства, а вторая стеночная конструкция выполнена проницаемой для лекарственного средства, при этом
(i) первая стеночная конструкция выполнена в виде цилиндрической трубки,
а вторая стеночная конструкция выполнена в виде торцевой стенки, расположенной по меньшей мере на одном конце цилиндрической трубки, или
(ii) первая стеночная конструкция и вторая стеночная конструкция примыкают друг к другу и совместно образуют цилиндрическую трубку.
15. Способ по п. 14, согласно которому имплантирование устройства для доставки лекарственных средств в тело пациента включает введение этого устройства в полость тела или в полость у пациента посредством инструмента развертывания.
16. Способ по п. 14, согласно которому развертывание устройства для доставки лекарственных средств в тело пациента включает:
упругую деформацию указанного устройства в относительно выпрямленную форму;
введение указанного устройства через уретру пациента; и
высвобождение указанного устройства в мочевой пузырь пациента таким образом, что оно принимает форму удержания, подходящую для удержания этого устройства внутри мочевого пузыря.
17. Способ по п. 14, согласно которому скорость высвобождения лекарственного средства из устройства для доставки лекарственных средств представляет собой скорость нулевого порядка в течение по меньшей мере 36 часов.
18. Способ по п. 14, согласно которому скорость высвобождения лекарственного средства из устройства для доставки лекарственных средств представляет собой по существу скорость нулевого порядка в течение по меньшей мере 7 дней.
19. Способ по п. 18, согласно которому лекарственное средство содержит лидокаин, гемцитабин, доцетаксел, карбоплатин, цисплатин, оксалиплатин, троспий, толтеродин, оксибутинин или митомицин C.
20. Способ по п. 14, согласно которому высвобождение лекарственного средства дополнительно включает растворение этого лекарственного средства в воде, впитанной через вторую стеночную конструкцию или через первую и вторую стеночные конструкции.
21. Способ по п. 20, согласно которому лекарственное средство выполнено в виде одного или большего количества твердотельных единиц лекарственного средства.
RU2015139934A 2013-03-15 2014-03-17 Устройство для доставки лекарственных средств с проницаемым для лекарственного средства компонентом и способ доставки лекарственных средств RU2666684C2 (ru)

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US20190329011A1 (en) 2019-10-31
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EP2968880A1 (en) 2016-01-20
KR102293280B1 (ko) 2021-08-23
US10315019B2 (en) 2019-06-11
US10286199B2 (en) 2019-05-14
KR20210104941A (ko) 2021-08-25
WO2014145638A1 (en) 2014-09-18
JP6517186B2 (ja) 2019-05-22
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US20220211987A1 (en) 2022-07-07
AU2019202670B2 (en) 2020-04-02
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AU2014232801A1 (en) 2015-09-17
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