Transdermal drug delivery device and method for its manufacture

• US 5,505,958 A
• Filed: 10/31/1994
• Issued: 04/09/1996
• Est. Priority Date: 10/31/1994
• Status: Expired due to Fees

• Current Assignee: Pharmadyn Incorporated
• Original Assignee: Algos Pharmaceutical Corp. (Endo International PLC)
• Inventors: Johnson, Donald A., Lyle, John W., Bello, Gastone P.
• Primary Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US08/331,724
• Time in Patent Office: 526 Days
• Field of Search: 424/448, 424/449, 424/443, 602/64, 602/46
• US Class Current: 424/449
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/0246 characterised by the skin-adhering layer
• CPC Class Codes: A61F 2013/00906 for transcutaneous or transdermal drugs application
• CPC Class Codes: A61F 2013/0296 for making transdermal patches (chemical processes excluded)
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• 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

Abstract

A transdermal drug delivery device possessing a drug-storing matrix and at least one drug delivery device-securing component is manufactured from the same flexible cellular thermoplastic resin workpiece.

Claims

1. A transdermal drug delivery device which comprises:

a) a drug-storing matrix of flexible cellular structure fabricated from a flexible cellular thermoplastic resin workpiece;

b) at least one drug stored in the drug-storing matrix; and

,

c) at least one drug delivery device-securing component adjacent the drug-storing matrix for securing the drug delivery device to a surface of unbroken skin, the drug delivery device-securing component possessing a flexible component of collapsed cellular structure resistant to penetration of drug from the drug-storing matrix and fabricated from the same thermoplastic resin workpiece as the drug-storing matrix, the drug delivery device-securing component together with the drug-storing matrix constituting a seamless unitary whole.

2. The drug delivery device of claim 1 wherein the drug-storing matrix possesses a drug-impermeable barrier film or layer to prevent diffusion of drug to an exterior surface of the drug delivery device.

3. The drug delivery device of claim 1 wherein the drug delivery device-securing component includes first and second strap members of collapsed cell structure extending from opposite sides of the drug-storing matrix.

4. The drug delivery device of claim 1 wherein the drug delivery device-securing component includes a continuous band of collapsed cell structure surrounding the drug-storing matrix, the band of collapsed cell structure being coated with pressure-sensitive adhesive on the skin-contacting side thereof.

5. The drug delivery device of claim 3 wherein the first and second strap members are coated with pressure-sensitive adhesive on the skin-contacting sides thereof.

6. The drug delivery device of claim 3 adapted for encircling a body part wherein the first strap member possesses arrowhead projections and the second strap member possesses an aperture and retaining tab for locking engagement with the arrowhead projections of the first strap member.

7. The drug delivery device of claim 3 adapted for encircling a body part wherein the first strap member is provided with hooks and the second strap member is provided with loops, the hooks of the first strap member being engageable with the loops of the second strap member to form a shear-resistant band.

8. The drug delivery device of claim 2 wherein the drug-impermeable barrier film or layer is disposed within the interior of the drug-storing matrix.

9. The drug delivery device of claim 1 wherein the skin-contacting surface of the drug delivery device-securing component and the skin-contacting surface of the drug-storing matrix lie substantially in the same plane.

10. The drug delivery device of claim 1 wherein the drug-storing matrix and the component of collapsed cellular structure are formed from a polyurethane resin workpiece.

11. The drug delivery device of claim 1 wherein the drug is a local anesthetic.

12. The drug delivery device of claim 11 wherein the local anesthetic is combined with a penetration enhancer.

13. The drug delivery device of claim 1 wherein the drug is an antibiotic.

14. A method for manufacturing a transdermal drug delivery device possessing a drug-storing matrix having at least one drug stored therein and at least one drug delivery device-securing component, which comprises:

a) designating a first region of a flexible cellular thermoplastic workpiece as a region in which the cellular structure of the workpiece is to be irreversibly collapsed and a second region of the workpiece as a region in which a drug-storing cellular structure is to be retained;

b) irreversibly collapsing the cellular structure in the first region of the workpiece prior to or following storing at least one drug in the second region of the workpiece, the second region of drug-storing cellular structure providing the drug-storing matrix of the drug delivery device, the first region of collapsed cellular structure and the second region of drug-storing cellular structure constituting a seamless unitary whole; and

,

c) providing the first region of collapsed cellular structure with means for securing the drug delivery device to a surface of unbroken skin, the first region of collapsed cellular structure and the means for securing the drug delivery device providing the drug delivery device-securing component of the drug delivery device.

15. The method of claim 14 wherein heat and pressure are applied to the first region of the workpiece to irreversibly collapse the cellular structure of the workpiece in such region.

16. The method of claim 14 wherein the drug-storing matrix is provided with a drug-impermeable barrier to present diffusion of drug to an exterior surface of the drug delivery device.

17. The method of claim 16 wherein the drug-impermeable barrier is interposed between layers of workpiece to provide a workpiece assembly and heat and pressure are applied to the first region of the workpiece assembly to irreversibly collapse the cellular structure in such region and bond the layers of workpiece and drug-impermeable barrier to each other in such region.

18. The method of claim 14 wherein the skin-contacting surface of the first region of collapsed cellular structure and the skin-contacting surface of the second region of drug-diffusing cellular structure lie substantially in the same plane.

19. The method of claim 14 wherein the workpiece is a thermoplastic polyurethane resin workpiece.