Multicompartmentalized transdermal patches

• US 4,666,441 A
• Filed: 12/17/1985
• Issued: 05/19/1987
• Est. Priority Date: 12/17/1985
• Status: Expired due to Term

• Current Assignee: Novartis Corporation (Novartis Ag)
• Original Assignee: Ciba-Geigy Corporation (Novartis Ag)
• Inventors: Moore, Donald J., Andriola, Robert, Asche, Henning
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Smith, Jr., Jerome R.
• Application Number:
  US06/810,102
• Time in Patent Office: 518 Days
• Field of Search: 604/303-308, 604/890-892, 604/897, 424/28, 128/156
• US Class Current: 424/448
• CPC Class Codes: A61F 13/0243 characterised by the properties of the skin contacting layer, e.g. air-vapor permeability
• CPC Class Codes: A61F 13/0259 characterised by the release liner covering the skin adhering layer
• CPC Class Codes: A61K 9/7084 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
• CPC Class Codes: A61K 9/7092 Transdermal patches having multiple drug layers or reservoirs, e.g. for obtaining a specific release pattern, or for combining different drugs

Abstract

A dermal or transdermal patch comprising (1) a backing layer which is non-permeable with respect to a drug formulation to be contained within the patch, (2) a membranous layer, which is permeable to the drug, having a first surface partially in contact with said backing layer so as to define multiple compartments, (3) at least one drug or drug formulation contained within said compartments, (4) an adhesive layer on a second surface of said membranes layer, and (5) a peelable protective cover layer on said adhesive layer.

Claims

1. In a transdermal or dermal patch for administering a controlled amount of a drug to skin or mucous membrane comprising, in sequence,

A. a backing layer which is not permeable to said drug,

B. a first membranous layer permeable to said drug, said first membranous layer and said backing layer being sealed together so as to define an enclosure for containing said drug,

C. said drug contained within said enclosure,

D. an adhesive layer on said first membranous layer, and

E. a first removeable protective layer on said adhesive layer,

the improvement which comprises

subdividing said enclosure into at least two compartments, at least one of said compartments containing therein a drug, drug concentration, or drug formulation which differs from that contained in at least one other of said compartments.

2. The patch of claim 1 wherein each compartment is no greater than 30 cm² in area.

3. The patch of claim 1 wherein the maximum distance from the center of gravity of a compartment and a boundary of said compartment is 2.70 cm.

4. The patch of claim 1 wherein the perimeter of a compartment is no greater than 4.04 times the square root of that compartment area.

8. The patch of claim 1 wherein said drug is nitroglycerine or arecoline.

9. The patch of claim 1 wherein at least one compartment contains a drug formulation having a flux enhancer as a component thereof.

10. A method of administering a drug to a patient comprising removing said removeable layer from a patch of claim 1 to expose an adhesive layer and applying said patch absent said removeable layer, to said patient so that said adhesive layer contacts said patient.

5. In a transdermal or dermal patch for administering a controlled amount of a drug to skin or mucous membrane comprising, in sequence,

A. a backing layer which is not permeable to said drug,

B. a first membranous layer permeable to said drug, said first membranous layer and said backing layer being sealed together so as to define an enclosure for containing said drug,

C. said drug contained within said enclosure,

D. an adhesive layer on said first membranous layer, and

E. a first removeable protective layer on said adhesive layer,

the improvement which comprises

subdividing said enclosure into at least two compartments, at least one of said compartments containing therein a drug, drug concentration, or drug formulation which is the same as or differs from that contained in at least one other of said compartments wherein at least one compartment, but not all, is modified by having a nonpermeable membrane thereon in addition to or in place of said first membranous layer or has an occlusive adhesive in addition to or in place of said adhesive layer so as to prevent said drug within said modified compartment from passing therethrough.

11. The patch of claim 5 wherein said drug is nitroglycerine or arecoline.

14. The patch of claim 5 wherein at least one compartment contains a drug formulation having a flux enhancer as a component thereof.

17. A method of administering a drug to a patient comprising removing said removeable layer from a patch of claim 5 to expose an adhesive layer and applying said patch absent said removeable layer, to said patient so that said adhesive layer contacts said patient.

6. In a transdermal or dermal patch for administering a controlled amount of a drug to skin or mucous membrane comprising, in sequence,

A. a backing layer which is not permeable to said drug,

B. a first membranous layer permeable to said drug, said first membranous layer and said backing layer being sealed together to as to define an enclosure for containing said drug,

C. said drug contained within said enclosure,

D. an adhesive layer on said first membranous layer, and

E. a first removeable protective layer on said adhesive layer,

the improvement which comprises

subdividing said enclosure into at least two compartments, at least one of said compartments containing therein a drug, drug concentration, or drug formulation which is the same as or differs from that contained in at least one other of said compartments wherein at least one compartment-compartment border comprises a non-burstable permeable membrane and a burstable, non-permeable membrane, said burstable membrane to be broken before, during, or after applying said patch to a patient.

12. The patch of claim 6 wherein said drug is nitroglycerine or arecoline.

15. the patch of claim 6 wherein at least one compartment contains a drug formulation having a flux enhancer as a component thereof.

18. A method of administering a drug to a patient comprising removing said removeable layer from a patch of claim 6 to expose an adhesive layer and applying said patch absent said removeable layer, to said patient so that said adhesive layer contacts said patient.

7. In a transdermal or dermal patch for administering a controlled amount of a drug to skin or mucous membrane comprising, in sequence,

A. a backing layer which is not permeable to said drug,

B. a first membranous layer permeable to said drug said first membranous layer and said backing layer being sealed together to as to define an enclosure for containing said drug

C. said drug contained within said enclosure,

D. an adhesive layer on said first membranous layer, and

E. a first removeable protective layer on said adhesive layer,

the improvement which comprises

subdividing said enclosure into at least two compartments, at least one of said compartments contained therein a drug, drug concentration, or drug formulation which is the same as or differs from that contained in at least one other of said compartments wherein a portion of said backing layer is replaced with a second permeable membrane in contact with said active agent, an additional adhesive layer on said second permeable membrane remote from said active agent and a second removeable protective layer on said additional adhesive, such that upon removal of said first removable protective layer, said patch may be folded upon itself, exposed adhesive to exposed adhesive to result in a final patch having one compartment located on top of another.

13. The patch of claim 7 wherein said drug is nitroglycerine or arecoline.

16. The patch of claim 7 wherein at least one compartment contains a drug formulation having a flux enhancer as a component thereof.

19. A method of administering a drug to a patient comprising removing said second removeable layer from a patch of claim 7 to expose an adhesive layer and applying said patch absent said removeable layer, to said patient so that said adhesive layer contacts said patient.