CA2453013A1 - Dermal, transdermal, mucosal or transmucosal ingredient delivery devices - Google Patents

Dermal, transdermal, mucosal or transmucosal ingredient delivery devices Download PDF

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Publication number
CA2453013A1
CA2453013A1 CA002453013A CA2453013A CA2453013A1 CA 2453013 A1 CA2453013 A1 CA 2453013A1 CA 002453013 A CA002453013 A CA 002453013A CA 2453013 A CA2453013 A CA 2453013A CA 2453013 A1 CA2453013 A1 CA 2453013A1
Authority
CA
Canada
Prior art keywords
cover
reservoir
opening
liner
sealing surface
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
CA002453013A
Other languages
French (fr)
Other versions
CA2453013C (en
Inventor
Gary W. Cleary
Adrian L. Faasse
Charles E. Lundy
Michael G. Marcoux
Sreenivasu Mudumba
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.)
Bayer Consumer Care Holdings LLC
Corium Corp
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 CA2729967A priority Critical patent/CA2729967C/en
Publication of CA2453013A1 publication Critical patent/CA2453013A1/en
Application granted granted Critical
Publication of CA2453013C publication Critical patent/CA2453013C/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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • 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

Abstract

A dermal, transdermal, mucosal or transmucosal delivery device is provided. The device includes a backing layer, defining an ingredient containing reservoir, a cover for the reservoir having at least one opening therethrough, an adhesive layer and a liner layer. Upon removal of the liner layer, the device may be placed over the desired area of the skin or mucosa and adhesively applied thereto allowing the ingredients to flow from the reservoir through the at least one opening to the dermis or mucosa.

Claims (12)

1. An ingredient delivery device, comprising:
a backing member defining an ingredient containing reservoir, said backing member being made of a material which is substantially impermeable to ingredients contained in said reservoir;
an ingredient contained in said reservoir comprising an organic solution, wherein said organic solution comprises:
a topically active drug agent;
an alkylene glycol;
a fatty acid ester;
a dialkylene glycol alkyl ether; and a polymeric thickening agent;
a cover for said reservoir, said cover being made of a material substantially impermeable to ingredients contained in said reservoir, but having at least one opening therein, such that ingredients to be delivered from said reservoir will flow through said opening, but will not readily flow through said material of which said cover is made;
said cover being sealed to said backing member at the perimeter of said reservoir by a first seal which is not subject to degradation by any ingredient to be contained in said reservoir;
an adhesive layer adhered to said backing member for adhering said device to a patient's skin or mucosa, said adhesive layer not extending to the perimeter of said opening in said cover, such that a portion of said cover surrounding said perimeter of said opening is exposed to thereby define a cover sealing surface; and a liner covering said sealing surface of said cover and said opening in said cover, said liner being releasably sealed to said sealing surface of said cover by a second seal which is not subject to degradation by any ingredient contained in said reservoir; whereby ingredients contained in said reservoir are sealed therein during storage and non-use by said first and second seals, said cover and liner, but are free to flow through said opening and onto a subject's skin or mucosa when said liner is removed from said device and said device is applied to such skin or mucosa.
2. The device of claim 1, wherein said liner is a release liner for said device, said release liner covering said adhesive layer as well as said sealing surface and said opening of said cover.
3. The device of claim 2, wherein said first and second seals are heat seals between said cover and said backing member and between said liner and said cover respectively.
4. The device of claim 3 in which said liner is a composite member comprising:
an outer protective layer and a barrier layer with an adhesive coating therebetween, and a release coating on the exposed surface of said barrier layer;

said barrier layer, including its adhesive coating and its release coating, having an opening therein which is sufficiently large to expose said opening and said sealing surface of said cover, whereby said outer protective layer is sealed directly to said sealing surface of said cover by said second seal.
5. The device of claim 4 in which said adhesive layer is a composite member comprising:
a first adhesive coating, a second adhesive coating and a barrier layer therebetween;
said barrier layer, including its first adhesive coating and its second adhesive coating, having an opening therein which is sufficiently large to expose said opening and said sealing surface of said cover, whereby said outer protective layer is sealed directly to said sealing surface of said cover by said second seal.
6. The device of claim 5, wherein said release coating of said liner is releasably adhered to said second adhesive coating of said adhesive layer.
7. The device of claim 6, wherein said reservoir comprises an absorbable material.
8. The device of claim 7, wherein said topically active drug agent is salicylic acid.
9. The device of claim 8, wherein said salicylic acid is present in an amount of from about 5 % to about 40% by weight of said organic solution.
10. The device of claim 9, wherein said alkylene glycol is propylene glycol.
11. The device of claim 10, wherein said fatty acid ester is glyceryl monoleate
12. The device of claim 11, wherein said dialkylene glycol alkyl ether is diethylene glycol monoethyl ether.
CA2453013A 2002-12-13 2003-12-11 Dermal, transdermal, mucosal or transmucosal ingredient delivery devices Expired - Fee Related CA2453013C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2729967A CA2729967C (en) 2002-12-13 2003-12-11 Use of a transdermal or transmucosal ingredient delivery device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US43320302P 2002-12-13 2002-12-13
US60/433,203 2002-12-13

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2729967A Division CA2729967C (en) 2002-12-13 2003-12-11 Use of a transdermal or transmucosal ingredient delivery device

Publications (2)

Publication Number Publication Date
CA2453013A1 true CA2453013A1 (en) 2004-06-13
CA2453013C CA2453013C (en) 2011-02-15

Family

ID=32595136

Family Applications (3)

Application Number Title Priority Date Filing Date
CA2453013A Expired - Fee Related CA2453013C (en) 2002-12-13 2003-12-11 Dermal, transdermal, mucosal or transmucosal ingredient delivery devices
CA2729967A Expired - Fee Related CA2729967C (en) 2002-12-13 2003-12-11 Use of a transdermal or transmucosal ingredient delivery device
CA2509670A Expired - Lifetime CA2509670C (en) 2002-12-13 2003-12-12 Dermal, transdermal, mucosal or transmucosal ingredient delivery devices

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA2729967A Expired - Fee Related CA2729967C (en) 2002-12-13 2003-12-11 Use of a transdermal or transmucosal ingredient delivery device
CA2509670A Expired - Lifetime CA2509670C (en) 2002-12-13 2003-12-12 Dermal, transdermal, mucosal or transmucosal ingredient delivery devices

Country Status (7)

Country Link
US (1) US7976867B2 (en)
EP (1) EP1596842B1 (en)
AT (1) ATE422158T1 (en)
AU (2) AU2003297033A1 (en)
CA (3) CA2453013C (en)
DE (1) DE60326088D1 (en)
WO (1) WO2004054638A2 (en)

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Also Published As

Publication number Publication date
CA2729967A1 (en) 2004-06-13
CA2729967C (en) 2018-01-16
AU2003297033A1 (en) 2004-07-09
CA2509670C (en) 2012-03-13
DE60326088D1 (en) 2009-03-19
EP1596842A2 (en) 2005-11-23
AU2009233617A1 (en) 2009-11-26
US7976867B2 (en) 2011-07-12
EP1596842A4 (en) 2006-03-15
CA2509670A1 (en) 2004-07-01
WO2004054638A3 (en) 2004-08-12
ATE422158T1 (en) 2009-02-15
WO2004054638A2 (en) 2004-07-01
CA2453013C (en) 2011-02-15
EP1596842B1 (en) 2009-02-04
AU2009233617B2 (en) 2011-05-12
US20040166147A1 (en) 2004-08-26

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Legal Events

Date Code Title Description
EEER Examination request
MKLA Lapsed

Effective date: 20201211