Transdermal drug delivery device

• US 5,135,480 A
• Filed: 11/21/1990
• Issued: 08/04/1992
• Est. Priority Date: 07/10/1986
• Status: Expired due to Term

• Current Assignee: Elan Transdermal Limited (Perrigo Company PLC)
• Original Assignee: Elan Transdermal Limited (Perrigo Company PLC)
• Inventors: Corrigan, Owen I., Masterson, Joseph G., Corish, John, Bannon, Yvonne B.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): LACYK, JOHN P
• Application Number:
  US07/617,945
• Time in Patent Office: 622 Days
• Field of Search: 128/639-644, 128/635, 128/798, 128/799, 128/802, 128/803, 604/20
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

Abstract

A transdermal device having a detachably mounted electrode with a first surface adapted for contact with human skin and through which a drug substance contained in the electrode passes to the skin under the influence of an iontophoretic or electro-osmotic force and a second surface which is electrically conducting, the electrode has a surface area in contact with the skin, in use, in the range 0.1 to 30 cm² and a drug dissolved or dispersed in a hydrophilic medium at a concentration in the range 0.1 to 15% (w/v) based on the hydrophilic medium.

Claims

1. A transdermal device suitable for long term administration of a drug substance comprising:

a housing;

a complete electrical circuit having a first electrode detachably mounted within a recess in said housing, said first electrode having a first surface adapted for contact with human skin and through which the drug substance contained in the first electrode may pass to the skin under the influence of an iontophoretic or electro-osmotic force and a second surface remote from said skin-contacting surface which is electrically conducting and which is adapted for contact with an electrical source in said housing such that the first electrode can be discarded and replaced by a new electrode when the drug supply substance is exhausted, said first electrode having a surface area adapted to be in contact with the skin when in use, said drug substance being dissolved or dispersed in a hydrophilic medium defining said first electrode, and said second surface of said first electrode is drug impermeable, a means for adjusting the current, means for indicating the current is in the required range for correct administration, and a second electrode which is optionally detachable for completing said electrical circuit; and

a non-adhesive means for securing said device to the skin.

2. A transdermal device according to claim 1, wherein the hydrophilic medium is a gel material which is formed into a disc, one major surface of said disc defining said skin-contacting surface of said first electrode and a second major surface of said disc having an electrically conducting material adhered thereto and defining said second surface of said first electrode.

3. A transdermal device according to claim 2, wherein the disc of hydrophilic gel material has a drug permeable membrane attached to said one major surface and defining said skin-contacting surface of said first electrode and a layer of aluminium or platinum foil attached to said second major surface and defining said second surface of said first electrode.

4. A transdermal device according to claim 3, wherein the hydrophilic medium is selected from the group consisting of agar gel, karaya gum gel, a polyoxyethylene-polyoxypropylene gel, gelatin, sodium carboxymethylcellulose, a poly(ethylene oxide) polymer, methylcellulose, carboxyvinyl polymers cross linked with allyl sucrose and polyacrylamide gels or a mixture thereof.

5. A transdermal according to claim 1, wherein the hydrophilic medium contains one or more additional agents selected from the group consisting of antimicrobial agents, antifungal agents, preservatives, anti-oxidants, pH-controlling agents, plasticizers, surfactants, penetration enhancers, humectants, local anaesthetics and rubefacients.

6. A transdermal device according to claim 1, wherein the second electrode connected to said housing such that, when in use, will be situated is a different site on the skin to said first electrode.

7. A transdermal device according to claim 6, wherein the components of the electrical circuit, excluding the second electrode, are housed in a single unit, the exterior surface of said unit simulating the face of a time piece, said unit being mounted in a strap or bracelet for attachment to a limb of a body.

8. A transdermal device according to claim 7, wherein the unit includes an LCD and a galvanostat which regulates the current applied to the first electrode and maintains said current constant despite the varying resistance to the skin.

9. A transdermal device according to claim 1, wherein the drug substance is selected from the group consisting of clonidine, insulin, morphine, nicotine, orcipreniline, salbutamol, sodium chromoglycate and desmopressin or a pharmaceutically acceptable salt thereof.

10. A transdermal device according to claim 1, wherein said second electrode is also an electrode of the type as defined for said first electrode, such that the transdermal device incorporating said first and second electrodes may be used to administer two drugs simultaneously by the transdermal route.

11. A transdermal device according to claim 1, wherein the surface area of the first electrode adapted to be in contact with the skin is in the range of 0.1 to 30 cm².

12. A transdermal device according to claim 1, wherein the drug substance has a concentration in the range of 0.1 to 15% weight/volume based on the hydrophilic medium.

13. A transdermal device comprising a housing first electrode detachably mounted to said housing and an electrical source within said housing wherein said housing is mounted in a strap or bracelet for attachment to a limb of a body, said first electrode having a fist surface with a surface area adapted for contact with human skin when in use, a drug substance dissolved or dispersed in a hydrophilic medium defining said first electrode which can pass to the skin under the influence of an iontophoretic or electroosmotic force created by said electrical source, and a second surface remote from said first surface which is drug impermeable, electrically conducting and an integral part of said first electrode, said second surface further being adapted for contact with said electrical source, and a second electrode in said strap or bracelet for connection to said electrical source and adapted to be situated at a different site on the skin to said first electrode.

14. The transdermal device according to claim 13, wherein said second electrode is also an electrode of the type as defined for said first electrode, such that the transdermal device incorporating said first and second electrodes may be used to administer two drugs simultaneously by the transdermal route.

15. A transdermal device according to claim 13, wherein the surface area of the first electrode adapted to be in contact with the skin is in the range of 0.1 to 30 cm².

16. A transdermal device according to claim 13, wherein the drug substance has a concentration in the range of 0.1 to 15% weight/volume based on the hydrophilic medium.