Medicament-loaded transdermal reservoir and method for its formation

• US 6,496,727 B1
• Filed: 05/31/2000
• Issued: 12/17/2002
• Est. Priority Date: 05/31/2000
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kupperblatt, Gary, Karl, Curtis, Bernhard, Michael I., OʼGrady, Daniel, Ewall, Ralph, Keusch, Preston
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US09/584,453
• Time in Patent Office: 930 Days
• Field of Search: 604/19, 604/20, 424/443, 424/446-449
• US Class Current: 604/20
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

A transdermal reservoir and method for loading a material into a reservoir includes providing a bibulous reservoir blocking a backing with an interior surface having a patient contact surface with a shape disposed on the interior surface of the backing. A closure is sized and shaped to engage the backing for forming a releasable seal to isolate the bibulous reservoir from the ambient environment. The closure has an inside surface with a section of an absorbent material disposed thereon. When the closure is disposed on the backing, the absorbent material is positioned in intimate physical contact with the reservoir. The method includes applying an aliquot of a material to the absorbent material,. placing the closure on the backing so that the absorbent material is in intimate physical contact with the contact surface of the bibulous reservoir and the closure forms the releasable seal with the backing. The reservoir is allowed to stand for a sufficient time to allow the aliquot to be absorbed into the bibulous material thereby loading the reservoir.

Claims

1. A method for loading a material into a hydrophilic transdermal medicament delivery reservoir comprises:

providing a transdermal delivery device including a backing having an interior surface comprising a bibulous reservoir having a patient contact surface disposed on said interior surface;

placing a section of an absorbent material on said patient contact surface of said bibulous reservoir;

applying a preselected aliquot of a material to be charged into said bibulous reservoir onto said absorbent material; and

allowing said bibulous reservoir having said absorbent material with said aliquot of the material applied thereto to stand for a sufficient time for the material to be absorbed into said bibulous material, thereby loading said material into said reservoir.

2. The method of claim 1 further comprising providing a closure sized and shaped to engage said backing for forming a releasable seal to isolate said bibulous reservoir from ambient environment, said closure engaging said backing after placing and said applying step, said closure being removable from said backing to expose said patient contact surface for use.

3. The method of claim 1 wherein said applying step for applying said aliquot of said material to said absorbent material is performed before said placing step of placing said absorbent material on said patient contact surface of bibulous material.

4. The method of claim 1 wherein said providing step for providing said transdermal delivery device including a backing further comprises said interior surface comprising an electrode, said bibulous reservoir being disposed on and in electrical contact with said electrode.

5. The method of claim 1 wherein said providing step for said reservoir selected from the group consisting of gums, alginates, alkyl and hdroxyalkylalkylcellulose, carbosymethylcellulose, gum agar, hydroxethylcellulose, locust bean gum, pectins, polyacrylamide, polyethylene glycol, poly(ethylene oxide), polyvinyl alcohol, poly(vinylpyrolidone) and combinations thereof.

6. The method of claim 5 wherein said providing step for said reservoir further comprises forming said bibulous reservoir from cross-linked poly(vinylpyrolidone).

7. A method for loading a material into an iontophoresis reservoir electrode comprises:

providing an iontophoresis reservoirelectrode including a backing with an interior surface comprising an electrode, a bibulous reservoir having a patient contact surface with a shape disposed on said electrode and in electrical contact with said electrode;

providing a closure sized and shaped to engage said backing for forming a releasable seal to isolate said bibulous reservoir from ambient environment, said closure being removable from said backing to expose said patient contact surface for use, said closure having an inside surface with a section of an absorbent material disposed thereon, said section having a first surface so that when said closure is disposed on said backing, said absorbent material first surface is positioned in intimate physical contact with said patient contact surface of said reservoir;

applying a preselected aliquot of a material to said absorbent material on said inside surface of said closure;

placing said closure on said backing so that said first surface of said absorbent material is in intimate physical contact with said patient contact surface of said bibulous reservoir and said closure forms said releasable seal with said backing;

allowing said iontophoretic reservoir-electrode having said closure applied thereto to stand for a sufficient time, thereby allowing said aliquot of said material to be absorbed into said bibulous reservoir thereby loading said reservoir-electrode.

8. The method of claim 7 wherein said step of providing said closure having said section of said absorbent material disposed thereon further comprises providing a section of absorbent material having a similar shape to said shape of said patient contact surface of said bibulous reservoir.

9. The method of claim 7 wherein said providing step for said iontophoresis reservoir-electrode further comprises providing said backing in the form of a first web having a plurality of reservoir-electrodes spaced apart thereon.

10. The method of claim 9 wherein said providing step further comprises providing said closure in the form of a second web having a plurality of said sections of absorbent material spaced apart thereon to be in registration with said iontophoresis reservoir-electrodes on said first web.

11. The method of claim 10 wherein said providing step for said closure in the form of said second web further comprises forming a depression in said closure being sized and shaped to accept said section of said absorbent material so that when said aliquot of said loading material is applied to said section, said aliquot is substantially retained about said section.

12. The method of claim 11 wherein said providing step for said first web and said second web further comprises applying a releasable sealing material to one of said first web and said second web so that when said first web and said second web are disposed to said closure is being placed on said backing, said releasable sealing material forms said releasable seal between said first web and said second web.

13. The method of claim 12 further comprising positioning said first web with respect to said second web so that as said first web and said second web are advanced in a direction so that said closure is disposed to form said seal with said backing.

14. The method of claim 13 further comprising at least one cutting step for freeing each of said plurality of reservoir-electrodes each having said closure thereon from said webs as a unit.

15. The method of claim 14 wherein said providing step for said reservoir-electrode further comprises providing at least a first reservoir-electrode and a second reservoir-electrode, each reservoir-electrode comprising an electrode, a bibulous reservoir with a patient contact surface having a shape, said reservoir-electrodes being disposed on said interior surface of said backing.

16. The method of claim 15 wherein said providing step for said reservoir-electrode further comprises said first reservoir-electrode and said second reservoir-electrode being arranged in pairs electrically isolated from one another on said backing.

17. The method of claim 16 wherein said applying step for said reservoir electrode further comprises applying a first aliquot to said section of absorbent material in registration with said first reservoir-electrode and a second aliquot, different from said first aliquot, to said section of said section of absorbent material in registration with said second reservoir-electrode.

18. The method of claim 17, wherein said providing step for said reservoir-electrode further comprises providing said first reservoir-electrode and said second reservoir-electrode having a different shape from each other.

19. The method of claim 7 wherein providing step for said closure further comprises selecting said absorbent material from the group consisting of paper, polymeric foam, porous polymeric sheeting, non-woven matrices and combinations thereof.

20. The method of claim 18 wherein said selecting step further comprises selecting a non-woven material having a basis weight between about 5 mg and 20 mg per cm².

21. The method of claim 20 wherein said providing step for said closure further comprises fixedly attaching said absorbent material to said inside surface of said closure, so that when said closure is removed from said backing to prepare for a use of said iontophoretic reservoir-electrode, said absorbent material is removed as a part of said closure thereby exposing said patient contact surface of said reservoir for application to the patient'"'"'s skin.

22. The method of claim 7 wherein said applying step for said material to said absorbent material further comprises applying at least one medicament in an aqueous solution.

23. The method of claim 22 wherein said applying step for said material further comprises applying an aqueous solution having materials selected from the group consisting of lidocaine hydrochloride, epinephrine bitartrate, sodium chloride, glycerin, phenoxy ethanol, citric acid, sodium meta-bisulfite, edetate disodium and alkyl esters of para-hydroxy benzoic acid and combinations thereof.

24. A method for preparing a charged reservoir-electrode unit comprising a first reservoir-electrode disposed to operate as an anode and a second reservoir-electrode disposed to operate as a cathode comprises:

providing a backing material in the form of a first web having an interior surface;

providing a first reservoir-electrode having a first surface area, said first reservoir-electrode comprising an first electrode disposed on said interior surface of said backing, a first bibulous reservoir having a first patient contact surface having a shape being disposed on and in electrical contact with said first electrode;

providing a second reservoir-electrode having a second surface area, said reservoir-electrode comprising a second electrode disposed on said interior surface of said backing in electrical isolation from said first electrode, a bibulous second reservoir having a second patient contact surface having a shape being disposed on and in electrical contact with said second electrode;

providing a closure in the form of a second web disposed to engage said backing for forming a releasable seal to isolate said first and said second bibulous reservoirs from ambient environment, said closure being removable from said housing to expose said patient contact surfaces for use, said closure having an inside surface with sections of an absorbent material in register with said first and said second reservoir-electrodes disposed thereon, each said sections having a first surface with a similar shape to each of said patient contacting surfaces of said bibulous reservoirs so that when said closure is disposed on said backing, said absorbent materials first surfaces are each positioned in intimate physical contact with said contact surface of said reservoirs;

applying a preselected aliquot of a first material to said section in register with said first reservoir and an aliquot of a second material to said section in register with said second reservoir;

advancing said first web and said second web in a direction so that said first surface of said absorbent materials are in intimate physical contact with said patient contact surfaces of said bibulous reservoirs and said closure forms said releasable seal with said backing;

cutting each of said first and said second reservoir-electrodes each having said closure thereon from said webs as a unit; and

allowing said iontophoretic reservoir-electrode unit having said closure applied thereto to stand for a sufficient time, thereby allowing said aliquots of said materials to be absorbed into said bibulous materials thereby loading said reservoir-electrodes.

25. An iontophoresis reservoir-electrode comprising:

a backing with an interior surface comprising an electrode, bibulous reservoir loaded with a preselected aliquot of a material and having a patient contact surface with a shape disposed on said electrode and in electrical contact with said electrode;

a closure sized and shaped to engage and being disposed on said backing for forming a releasable seal to isolate said bibulous reservoir from ambient environment, said closure being removable from said backing to expose said patient contact surface for use, said closure having an inside surface with a section of an absorbent material disposed thereon, said section having a first surface with a similar shape to said patient contact surface of said bibulous reservoir with said closure disposed on said backing, so that said absorbent material first surface is positioned in intimate physical contact with said contact surface of said bibulous reservoir when said closure is disposed on said backing and removed from patient contact surface of said bibulous reservoir when said closure is removed from said backing.