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RU2018127642A - Системы и способы длительного трансдермального введения - Google Patents

Системы и способы длительного трансдермального введения Download PDF

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Publication number
RU2018127642A
RU2018127642A RU2018127642A RU2018127642A RU2018127642A RU 2018127642 A RU2018127642 A RU 2018127642A RU 2018127642 A RU2018127642 A RU 2018127642A RU 2018127642 A RU2018127642 A RU 2018127642A RU 2018127642 A RU2018127642 A RU 2018127642A
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layer
adhesive layer
patch according
paragraphs
active substance
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RU2018127642A
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RU2018127642A3 (ru
RU2737464C2 (ru
Inventor
Еун Соо ЛИ
Амит К. ДЖАИН
Парминдер СИНГХ
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Кориум Интернэшнл, Инк.
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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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7069—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. polysiloxane, polyesters, polyurethane, polyethylene oxide
    • 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
    • A61M35/00—Devices for applying media, e.g. remedies, on the human body
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Dermatology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (32)

1. Трансдермальный пластырь, содержащий:
первый покровный слой, состоящий из эластичного материала;
стыковочный клейкий слой;
второй покровный слой, состоящий из множества сегментов, которые по меньшей мере частично разделены;
клейкий слой с действующим веществом, состоящий из множества сегментов, которые по меньшей мере частично разделены, и содержащий по меньшей мере одно действующее вещество;
контактный клейкий слой, расположенный дистально относительно клейкого слоя с действующим веществом;
защитное покрытие.
2. Пластырь по п.1, в котором второй покровный слой и клейкий слой с действующим веществом вместе содержат составной слой, при этом составной слой состоит из множества сегментов, которые по меньшей мере частично разделены, причем слои составного слоя наслоены вместе.
3. Пластырь по п.1 или 2, в котором множество сегментов второго покровного слоя и/или клейкого слоя с действующим веществом по меньшей мере частично соединены.
4. Пластырь по любому из пп. 1-3, в котором первый покровный слой состоит из эластичной полимерной пленки, многонаправленного эластичного тканого материала, многонаправленного эластичного нетканого материала, растягивающейся полимерной пленки, растягивающегося тканого материала или растягивающегося нетканого материала.
5. Пластырь по любому из пп. 1-4, в котором первый покровный слой состоит из одного или более полимеров, выбранных из сложных полиэфиров, полиэтиленов, полипропиленов, поливинилхлорида, полиэтиленвинилацетата или его сополимеров, и полиуретанов.
6. Пластырь по п.1, в котором первый покровный слой имеет толщину приблизительно 0,2-50 мил.
7. Пластырь по любому из пп. 1-6, в котором стыковочный клейкий слой состоит из одного или более полимеров, выбранных из акрилатов, сополимеров акрилата, полиизобутилена, силикона, полистирола, бутилкаучука, полиэтиленвинилацетата и его сополимеров, и пластифицированных полимеров.
8. Пластырь по любому из пп. 1-7, в котором второй покровный слой состоит из материала, выбранного из окклюзивного материала и воздухопроницаемого материала.
9. Пластырь по любому из пп. 1-8, в котором второй покровный слой состоит из одного или более полимеров, выбранных из сложных полиэфиров, полиэтиленов, полипропиленов, полистиренов, поливинилхлорида и ламината из полиэтилентерефталата/этиленвинилацетата.
10. Пластырь по любому из пп. 2-9, в котором составной слой дополнительно содержит связующий слой, расположенный дистально относительно клейкого слоя с действующим веществом.
11. Пластырь по п.10, в котором связующий слой представляет собой мембрану, регулирующую скорость высвобождения, которая регулирует скорость высвобождения действующего вещества.
12. Пластырь по п. 10 или 11, в котором связующий слой состоит из пористого полимерного материала мембраны.
13. Пластырь по любому из пп. 2-12, в котором составной слой дополнительно содержит контактный клейкий слой, расположенный между клейким слоем с действующим веществом и защитным покрытием.
14. Пластырь по любому из пп. 2-13, в котором каждый сегмент составного слоя имеет размер приблизительно 2-40 см2.
15. Пластырь по любому из пп. 1-14, в котором стыковочный клейкий слой содержит первый клейкий слой, прилегающий к первому покровному слою, и второй клейкий слой, прилегающий ко второму покровному слою.
16. Пластырь по любому из пп. 2-15, в котором по меньшей мере первый покровный слой и защитное покрытие имеют размер, обеспечивающий их прохождение на около 0,5-1,0 см за пределы периметра составного клейкого слоя.
17. Пластырь по любому из пп. 1-16, в котором защитное покрытие состоит из материала, выбранного из покрытого силиконом материала, покрытого фторуглеродом материала и покрытого фторсиликоном материала.
18. Пластырь по любому из пп. 1-17, в котором вместе наслоены по меньшей мере первый покровный слой и стыковочные клейкие слои.
19. Пластырь по любому из пп. 1-18, дополнительно содержащий:
связующий слой, расположенный между клейким слоем с действующим веществом и контактным клейким слоем;
при этом по меньшей мере клейкий слой с действующим веществом, связующий слой и контактный клейкий слой наслоены вместе.
20. Пластырь по п. 19, в котором по меньшей мере второй покровный слой, клейкий слой с действующим веществом, связующий слой контактный клейкий слой наслоены вместе в виде составного слоя, и составной слой состоит из множества сегментов, которые по меньшей мере частично разделены.
21. Пластырь по любому из пп. 1-20, в котором клейкий слой с действующим веществом состоит из клейкой матрицы.
22. Способ трансдермального введения действующего вещества, включающий:
удаление защитного покрытия с трансдермального пластыря по любому из пп. 1-21; и
приклеивание трансдермального пластыря к коже пациента на период вплоть до около 10 дней для доставки действующего вещества пациенту.
RU2018127642A 2015-12-30 2016-12-30 Системы и способы длительного трансдермального введения RU2737464C2 (ru)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562273288P 2015-12-30 2015-12-30
US62/273,288 2015-12-30
US201662367055P 2016-07-26 2016-07-26
US62/367,055 2016-07-26
PCT/US2016/069558 WO2017117554A1 (en) 2015-12-30 2016-12-30 Systems and methods for long term transdermal administration

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RU2018127642A true RU2018127642A (ru) 2020-02-03
RU2018127642A3 RU2018127642A3 (ru) 2020-05-13
RU2737464C2 RU2737464C2 (ru) 2020-11-30

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US (6) US10966936B2 (ru)
EP (1) EP3397250B1 (ru)
JP (1) JP6833855B2 (ru)
KR (1) KR102774558B1 (ru)
CN (1) CN108697655B (ru)
AU (2) AU2016381351B2 (ru)
CA (1) CA3010183A1 (ru)
IL (2) IL260290B2 (ru)
MX (1) MX2018008190A (ru)
RU (1) RU2737464C2 (ru)
SG (1) SG11201805570WA (ru)
WO (1) WO2017117554A1 (ru)

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