CA2531504A1 - Transdermal patch incorporating active agent migration barrier layer - Google Patents

Transdermal patch incorporating active agent migration barrier layer Download PDF

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Publication number
CA2531504A1
CA2531504A1 CA002531504A CA2531504A CA2531504A1 CA 2531504 A1 CA2531504 A1 CA 2531504A1 CA 002531504 A CA002531504 A CA 002531504A CA 2531504 A CA2531504 A CA 2531504A CA 2531504 A1 CA2531504 A1 CA 2531504A1
Authority
CA
Canada
Prior art keywords
layer
active agent
adhering
host
mucosa
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002531504A
Other languages
French (fr)
Other versions
CA2531504C (en
Inventor
Kenneth J. Ii Miller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mylan Technologies Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA2637849A priority Critical patent/CA2637849C/en
Priority to CA2637321A priority patent/CA2637321C/en
Priority to CA2638743A priority patent/CA2638743C/en
Priority to CA2708347A priority patent/CA2708347C/en
Priority to CA002637297A priority patent/CA2637297C/en
Publication of CA2531504A1 publication Critical patent/CA2531504A1/en
Application granted granted Critical
Publication of CA2531504C publication Critical patent/CA2531504C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A61F2013/0296—Apparatus or processes for manufacturing adhesive dressings or bandages for making transdermal patches (chemical processes excluded)

Abstract

Devices (100) for administration of one or more active agents to the skin or mucosa of a host are formed in the nature of a double-disk patch (100). One outer layer (110) functions as the primary adhesive layer for adhering the patch (100) to the host. The other inner layer (122) contains at least one active agent to be administered to the host. The inner layer (122) is bonded to the outer layer (110) through an opening (114) provided in an interposed active agent impermeable release layer (104). The release layer (104) separates a circumferential portion of the active agent containing inner layer (122) from the outer adhesive layer (220) to inhibit migration of the active agent therebetween.

Claims (86)

1. A device for the release of an active agent to the skin or mucosa of a host, said device comprising an outer layer having adhesive properties; an inner layer having an active agent impermeable layer, said inner layer having a portion thereof adhered to said outer layer; and a release liner interposed between a portion of said impermeable layer and a portion of said outer layer, whereupon removal of said release liner exposes said outer layer for adhering said device to the skin or mucosa of a host.
2. The device of claim 1, wherein said release liner comprises an active agent impermeable material.
3. The device of claim 2, wherein said release liner is releasably adhered to said outer layer.
4. The device of claim 1, wherein said release liner includes an opening exposing a portion of said outer layer to which said impermeable layer of said inner layer is adhered.
5. The device of claim 4, wherein said inner layer includes a circumferential portion surrounding said opening within said release liner, said circumferential portion separated from said outer layer by said release liner interposed therebetween.
6. The device of claim 1, wherein said inner layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
7. The device of claim 1, further including a layer of active agent permeable adhesive applied overlying said inner layer for adhering said device to the skin or mucosa of a host.
8. The device of claim 1, wherein at least one of said outer layer and said inner layer includes an active agent to be administered to the skin or mucosa of a host.
9. The device of claim 1, further including a release liner releasably adhered to said inner layer.
10. A device for the release of an active agent to the skin or mucosa or a host, said device comprising a first layer having adhesive properties adapted for adhering said first layer to the skin or mucosa of a host; a second layer releasably adhered to said first layer, said second layer having an opening exposing a portion of said first layer; and a third layer overlying said second layer, said third layer including an active agent impermeable layer having a portion thereof adhered to said first layer within said opening in said second layer, said second layer separating a portion of said third layer from said first layer prior to removal of said second layer when adhering said device to the skin or mucosa of a host by said first layer.
11. The device of claim 10, wherein at least one of said first layer and said third layer includes an active agent to be administered to the skin or mucosa of a host.
12. The device of claim 10, wherein said second layer comprises an active agent impermeable material.
13. The device of claim 10, wherein said third layer includes a circumferential portion surrounding said opening within said second layer, said circumferential portion separated from said first layer by said second layer interposed therebetween.
14. The device of claim 10, wherein said second layer includes at least one slot extending from an edge of said second layer to said opening.
15. The device of claim 10, wherein said first layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
16. The device of claim 10, further including a layer of active agent impermeable material releasably applied overlying said third layer.
17. The device of claim 10, wherein said third layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
18. The device of claim 10, further including a layer of active agent permeable adhesive applied overlying said third layer for adhering said device to the skin or mucosa of a host.
19. The device of claim 10, wherein said first, second and third layers are planar layers overlying one another forming a laminate.
20. The device of claim 10, wherein said active agent impermeable layer is at least co-extensive with said third layer.
21. A device for the release of an active agent to the skin or mucosa of a host, said device comprising an outer layer having top and bottom surfaces, said top surface of said outer layer having adhesive properties adapted for adhering said outer layer to the skin or mucosa of a host; a liner releasably adhered to said top surface of said outer layer, said liner having an opening exposing a portion of said top surface of said outer layer; an active agent inner layer having an active agent overlying said liner, said inner layer having a surface area smaller than a surface area of said outer layer and greater than a surface area of said opening in said liner; and an active agent impermeable layer adhered to said bottom surface of said inner layer, said impermeable layer having a portion thereof adhered to said top surface of said outer layer within said opening in said liner, whereby a portion of said liner is interposed between a portion of said inner layer and a portion of said outer layer to inhibit migration of said active agent from said inner layer to said outer layer prior to adhering said device to the skin or mucosa of a host upon removal of said liner.
22. The device of claim 21, wherein said outer layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
23. The device of claim 21, wherein said outer layer includes an active agent to be administered to the skin or mucosa of a host.
24. The device of claim 21, wherein said liner comprises an active agent impermeable material.
25. The device of claim 21, wherein said active agent inner layer includes a circumferential portion surrounding said opening within said liner, said circumferential portion separated from said top surface of said outer layer by said liner interposed therebetween.
26. The device of claim 21, wherein said active agent inner layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
27. The device of claim 21, further including a layer of active agent permeable adhesive applied overlying said active agent inner layer for adhering said device to the skin or mucosa of a host.
28. The device of claim 2l, further including a release liner releasably adhered to said active agent inner layer.
29. The device of claim 21, wherein said active agent impermeable layer is at least co-extensive with the bottom surface of said inner layer.
30. A method for inhibiting migration of a component of an active agent release device between an inner layer and an adhesive outer layer within the device prior to adhering the device to the skin or mucosa of a host, said inner layer having a component impermeable layer partially adhered to said outer layer, said method comprising interposing a release liner between a peripheral portion of the inner layer and the outer layer.
31. The method of claim 30, wherein said release liner comprises a component impermeable material.
32. The method of claim 30, further including releasably adhering said release liner to said outer layer.
33. The method of claim 30, further including providing an opening within said release liner, and exposing a portion of said outer layer within said opening.
34. The method of claim 33, further including adhering said impermeable layer to said outer layer within said opening of said release liner.
35. The method of claim 34, wherein said peripheral portion of said inner layer circumscribes said opening of said release liner.
36. The method of claim 30, wherein said component impermeable layer is at least co-extensive with said inner layer.
37. The method of claim 36, wherein said release liner has a bottom surface releasbly adhered to said outer layer and a top surface unadhered underlying said component impermeable layer.
38. A method for inhibiting migration of an active agent from an active agent inner layer into an adhesive outer layer within an active agent release device prior to adhering the device to the skin or mucosa of a host, said inner layer having an active agent impermeable layer, said method comprising adhering a release liner to a first portion of the outer layer; and adhering a portion of the impermeable layer of the inner layer to a second portion of the outer layer, whereby a remaining portion of the impermeable layer is arranged overlying the release liner, said release liner separating a peripheral portion of the inner layer from the outer layer until removal of the release liner.
39. The method of claim 38, wherein said release liner comprises an active agent impermeable material.
40. The method of claim 38, further including releasably adhering said release liner to said outer layer.
41. The method of claim 38, further including providing an opening within said release liner, and exposing a portion of said outer layer within said opening.
42. The method of claim 41, wherein said portion of said impermeable layer is adhered to said second portion of said outer layer within said opening of said release liner.
43. The method of claim 41, wherein said remaining portion of said impermeable layer circumscribes said opening of said release liner.
44. The method of claim 38, wherein said active agent impermeable layer is at least co-extensive with said inner layer.
45. The method of claim 38, wherein said release liner has a bottom surface releasably adhered to said outer layer and a top surface unadhered underlying said active agent impermeable layer.
46. A method of making a device for the release of an active agent to the skin or mucosa of a host, said method comprising adhering a portion of an active agent impermeable layer of an inner layer to an outer layer having adhesive properties; and interposing a release liner between a portion of said impermeable layer and said outer layer, whereupon removal of said release liner exposes said outer layer for adhering said device to the skin or mucosa of a host.
47. The method of claim 46, wherein said release liner comprises an active agent impermeable material.
48. The method of claim 46, further including releasably adhering said release liner to said outer layer.
49. The method of claim 46, further including providing an opening within said release liner, and exposing a portion of said outer layer within said opening.
50. The method of claim 49, further including adhering said impermeable layer to said outer layer within said opening of said release liner.
51. The method of claim 46, wherein said active agent impermeable layer is at least co-extensive with said inner layer.
52. The method of claim 46, wherein said inner layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
53. The method of claim 46, further including a layer of active agent permeable adhesive applied overlying said inner layer for adhering said device to the skin or mucosa of a host.
54. The method of claim 46, wherein at least one of said outer layer and said inner layer includes an active agent to be administered to the skin or mucosa of a host.
55. The method of claim 46, wherein said outer layer comprises pressure-sensitive adhesive material.
56. The method of claim 46, wherein said inner layer, said outer layer and said impermeable layer are planar layers forming a laminate.
57. The method of claim 46, further including providing a release liner releasably adhered to said inner layer.
58. A method of making a device for the release of an active agent to the skin or mucosa or a host, said method comprising providing a first layer having adhesive properties adapted for adhering said first layer to the skin or mucosa of a host; releaseably adhering a second layer to said first layer, said second layer having an opening exposing a portion of said first layer; overlying a third layer with said second layer, said third layer including an active agent impermeable layer; and adhering a portion of said impermeable layer to said first layer within said opening in said second layer, said second layer separating a portion of said third layer from said first layer prior to removal of said second layer when adhering said device to the skin or mucosa of a host by said first layer.
59. The method of claim 58, wherein at least one of said first layer and said third layer includes- an active agent to be administered to the skin or mucosa of a host.
60. The method of claim 58, wherein said second layer comprises an active agent impermeable material.
61. The method of claim 58, wherein said third layer includes a circumferential portion surrounding said opening within said second layer, said circumferential portion separated from said first layer by said second layer interposed therebetween.
62. The method of claim 58, wherein said second layer includes at least one slot extending from an edge of said second layer to said opening.
63. The method of claim 58, wherein said first layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
64. The method of claim 58, further including a layer of active agent impermeable material releasably applied overlying said third layer.
65. The method of claim 58, wherein said third layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
66. The method of claim 58, further including a layer of active agent permeable adhesive applied overlying said third layer for adhering said device to the skin or mucosa of a host.
67. The method of claim 58, wherein said first, second and third layers are planar layers overlying one another forming a laminate.
68. The method of claim 58, wherein said active agent impermeable layer is at least co-extensive with said third layer.
69. The method of claim 58, wherein said third layer is larger than said opening within said second layer and smaller than said first layer.
70. A method of making a device for the release of an active agent to the skin or mucosa of a host, said method comprising providing an outer layer having top and bottom surfaces, said top surface of said outer layer having adhesive properties adapted for adhering said outer layer to the skin or mucosa of a host; releasably adhering a liner to said top surface of said outer layer, said liner having an opening exposing a portion of said top surface of said outer layer;
positioning an active agent inner layer having an active agent impermeable layer overlying said liner, said inner layer having a surface area smaller than a surface area of said outer layer and greater than a surface area of said opening in said liner; and adhering a portion of said impermeable layer to said top surface of said outer layer within said opening in said liner, whereby a portion of said liner is interposed between a portion of said inner layer and a portion of said outer layer to inhibit migration of said active agent from said inner layer to said outer layer prior to adhering said device to the skin or mucosa of a host upon removal of said liner.
71. The method of claim 70, wherein said outer layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
72. The method of claim 70, wherein said outer layer includes an active agent to be administered to the skin or mucosa of a host.
73. The method of claim 70, wherein said liner comprises an active agent impermeable material.
74. The method of claim 70, wherein said active agent inner layer includes a circumferential portion surrounding said opening within said liner, said circumferential portion separated from said top surface of said outer layer by said liner interposed therebetween.
75. The method of claim 70, wherein said active agent inner layer comprises pressure-sensitive adhesive material for adhering said device to the skin or mucosa of a host.
76. The method of claim 70, further including a layer of active agent permeable adhesive applied overlying said active agent inner layer for adhering said device to the skin or mucosa of a host.
77. The method of claim 70, further including a release liner releasably adhered to said active agent inner layer.
78. The method of claim 70, wherein said active agent impermeable layer is at least co-extensive with the bottom surface of said inner layer.
79. A method for inhibiting migration of a component of an active agent release device between an inner layer and an adhesive outer layer within the device prior to adhering the device to the,skin or mucosa of a host, at least one of said inner layer and said outer layer including said component, said inner layer having a component impermeable layer partially adhered to said outer layer within a bonding region, said method comprising interposing a release liner between a peripheral portion of the inner layer surrounding said bonding region and the outer layer.
80. The method of claim 79, wherein said release liner comprises material impermeable to said component.
81. The method of claim 79, further including releasably adhering said release liner to said outer layer.
82. The method of claim 79, further including providing an opening within said release liner, and exposing a portion of said outer layer within said opening.
83. The method of claim 82, further including adhering said impermeable layer to said outer layer within said opening of said release liner.
84. The method of claim 83, wherein said peripheral portion of said inner layer circumscribes said opening of said release liner.
85. The method of claim 79, wherein said impermeable layer is at least co-extensive with said inner layer.
86. The method of claim 85, wherein said release liner has a bottom surface releasbly adhered to said outer layer and a top surface unadhered underlying said impermeable layer.
CA2531504A 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer Expired - Fee Related CA2531504C (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2637849A CA2637849C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637321A CA2637321C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2638743A CA2638743C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2708347A CA2708347C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA002637297A CA2637297C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/641,654 US8524272B2 (en) 2003-08-15 2003-08-15 Transdermal patch incorporating active agent migration barrier layer
US10/641,654 2003-08-15
PCT/US2004/002105 WO2005018517A1 (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer

Related Child Applications (5)

Application Number Title Priority Date Filing Date
CA2708347A Division CA2708347C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2638743A Division CA2638743C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637321A Division CA2637321C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637849A Division CA2637849C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA002637297A Division CA2637297C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer

Publications (2)

Publication Number Publication Date
CA2531504A1 true CA2531504A1 (en) 2005-03-03
CA2531504C CA2531504C (en) 2011-04-12

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ID=34136410

Family Applications (6)

Application Number Title Priority Date Filing Date
CA2531504A Expired - Fee Related CA2531504C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2708347A Expired - Fee Related CA2708347C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637849A Expired - Fee Related CA2637849C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637321A Expired - Fee Related CA2637321C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA002637297A Expired - Fee Related CA2637297C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2638743A Expired - Fee Related CA2638743C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer

Family Applications After (5)

Application Number Title Priority Date Filing Date
CA2708347A Expired - Fee Related CA2708347C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637849A Expired - Fee Related CA2637849C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2637321A Expired - Fee Related CA2637321C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA002637297A Expired - Fee Related CA2637297C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer
CA2638743A Expired - Fee Related CA2638743C (en) 2003-08-15 2004-01-26 Transdermal patch incorporating active agent migration barrier layer

Country Status (7)

Country Link
US (3) US8524272B2 (en)
EP (1) EP1653897A4 (en)
JP (1) JP4388068B2 (en)
AU (1) AU2004266563B2 (en)
CA (6) CA2531504C (en)
MX (1) MXPA06001783A (en)
WO (1) WO2005018517A1 (en)

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CA2708347A1 (en) 2005-03-03
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CA2637297C (en) 2009-07-21
US20050037059A1 (en) 2005-02-17

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