Integrated apparatus for controlled heat aided dermal drug delivery

• US 6,546,281 B1
• Filed: 05/24/1999
• Issued: 04/08/2003
• Est. Priority Date: 07/28/1995
• Status: Expired due to Term

• Current Assignee: Nuvo Research AG (Searchlight Pharma, Inc.)
• Original Assignee: Zars, Inc.
• Inventors: Zhang, Hao, Zhang, Jie, Rigby, Larry, Hull, Wade A.
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/317,372
• Time in Patent Office: 1,415 Days
• Field of Search: 604/20, 604/289-291, 604/304, 604/305, 604/306, 604/113, 604/114, 128/114.1, 607/96, 607/108, 424/443, 424/447-449
• US Class Current: 604/20
• CPC Class Codes: A61F 2013/00187 insulating; warmth or cold applying
• CPC Class Codes: A61F 2013/00204 insulating
• CPC Class Codes: A61F 2013/00906 for transcutaneous or transdermal drugs application
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61F 7/032 using oxygen from the air, e.g. pocket-stoves
• CPC Class Codes: A61F 7/034 Flameless
• CPC Class Codes: A61K 31/4468 having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• 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

An integrated apparatus for controlled heat aided dermal drug delivery is disclosed. The apparatus has a temperature control component and a drug delivery component. The temperature control component may and dermal drug delivery component are an integrated unit. The apparatus also comprises means to prevent exchange of substance(s) among the heat generating component, the drug delivery component and the outside environment. The apparatus is designed to be easy to use.

Claims

1. A dermal drug delivery system comprising:

a temperature control component that is configured to selectively control an amount of heat generated by oxygen exposure;

a drug delivery component coupled to the temperature control component; and

means for preventing a transfer of substances between said temperature control component and said drug delivery component.

2. The dermal drug delivery system as set forth in claim 1, wherein the means for preventing a transfer of substances comprises a tray and a barrier film.

3. The dermal drug delivery system as set forth in claim 1, wherein the drug delivery component further comprises a tray defining a drug formulation reservoir and a drug formulation disposed within the drug formulation reservoir.

4. The dermal drug delivery system as set forth in claim 1, wherein the drug delivery component further comprises:

a tray;

a drug applicator; and

a drug formulation adherable to the drug applicator.

5. The dermal drug delivery system as set forth in claim 2, wherein the tray is substantially impermeable to moisture.

6. The dermal drug delivery system as set forth in claim 1, wherein the temperature control component comprises a heat generating element that is disposed within a chamber defined by a top wall, at least one side wall, and a bottom wall.

7. The dermal drug delivery system as set forth in claim 1, wherein the drug delivery component is selectively attachable to a patient'"'"'s skin, and wherein the temperature control component heats the skin under the drug delivery system to a temperature range between about 38°

and 45°

C.

8. The dermal drug delivery system as set forth in claim 1, wherein the temperature control component comprises a chamber defined by a foam tape frame and a base.

9. The dermal drug delivery system as set forth in claim 1, wherein the temperature control component comprises a heat generating medium disposed within a patch reservoir.

10. The dermal drug delivery system as set forth in claim 9, wherein the heat generating medium comprises iron and activated carbon.

11. The dermal drug delivery system as set forth in claim 1, wherein the temperature control component comprises exposably covered holes.

15. The dermal drug delivery system as set forth in claim 4, wherein the drug applicator comprises:

a film barrier having a top side;

a layer of fabric material coupled to the film barrier; and

an adhesive tape layer having an adhesive bottom side, wherein the top side of the film barrier is adhered to the bottom adhesive side of the tape layer.

16. The dermal drug delivery kit as set forth in claim 15, wherein the temperature control component is activated upon opening the kit and exposing the temperature control component to air and wherein the drug delivery component is separated from the tray in preparation for application to the skin of a user, said separation completely removing both the drug delivery component and the temperature control component in a single motion.

12. A dermal drug delivery kit comprising:

a drug delivery component;

a heat generating element that is configured to generate an amount of heat upon exposure to oxygen; and

a temperature control component configured to selectively control the amount of heat.

13. The dermal drug delivery kit as set forth in claim 12, wherein the drug delivery component comprises a barrier to inhibit a transfer of one or more substances into or out of the drug delivery component.

14. The dermal drug delivery kit as set forth in claim 12, wherein the drug delivery component comprises a drug formulation applicator and a drug formulation.

17. A dermal drug delivery system comprising:

a temperature control component configured to selectively control an amount of heat generated by exposure to oxygen; and

a drug delivery component associated with the temperature control component.

18. The dermal drug delivery system as set forth in claim 17, wherein the oxygen is from ambient air.

19. The dermal drug delivery system as set forth in claim 17, further comprising means for preventing undesired heat loss.

20. The dermal drug delivery system as set forth in claim 17, wherein the heat is generated by a heat generating medium comprising activated carbon, iron, and water.

21. The dermal drug delivery system as set forth in claim 17, wherein the drug delivery component comprises a drug formulation in a substantially two-dimensional matrix.

22. The dermal drug delivery system as set forth in claim 17, wherein the drug delivery component comprises a drug formulation disposed between a backing film and a rate-limiting membrane.

23. The dermal drug delivery system as set forth in claim 17, wherein the drug delivery component comprises a drug formulation disposed between a backing film and a non rate-limiting membrane.

24. The dermal drug delivery system as set forth in claim 17, wherein the drug delivery component comprises a drug selected from the group of fentanyl, sufentanil, carfentanil, testosterone, lidocaine, tetracaine, prilocaine, lopivocaine, bupivacaine, procaine, flurbiprofen, naproxen, ibuprofen, and dexmathesone.

25. The dermal drug delivery system as set forth in claim 17, wherein the drug delivery component comprises at least one of:

(i) an analgesic;

(ii) an anti-inflammatory agent;

(iii) a steroid;

(iv) an androgen;

(v) an estrogen;

(vi) a hormone;

(vii) an anti-viral agent;

(viii) an anti-asthma agent;

(ix) a cardiovascular agent;

(x) an anti-hypertension agent;

(xi) an antidepressant; and

(xii) a cox2 inhibitor.

26. The dermal drug delivery system as set forth in claim 17, further comprising means to isolate the drug delivery component from the environment.

27. The dermal drug delivery system as set forth in claim 17, further comprising means to prevent a transfer of one or more substances between said heating component and said drug delivery component.

28. The dermal drug delivery system as set forth in claim 27, wherein the means to prevent a transfer of one or more substances between said heating component and said drug delivery component comprises at least one of:

(i) a barrier material placed between said heating component and said drug delivery component;

(ii) said drug delivery component sealed into a space completely enveloped by a material substantially impermeable to moisture or alcohol; and

(iii) said heating component sealed into a space completely enveloped by a material substantially impermeable to moisture or alcohol.

29. A method for preparing a dermal drug delivery system that selectively employs heat generated by oxygen exposure, the method comprising the steps for:

disposing an anesthetic formulation within a formulation reservoir of a tray;

securing the anesthetic formulation within the tray to a drug applicator;

isolating from both an outside environment and a temperature control component the anesthetic formulation within the tray;

securing the temperature control component to the drug applicator, wherein the temperature control component selectively controls the heat generated by oxygen exposure; and

isolating the temperature control component from both the outside environment and from the anesthetic formulation.

30. The method of claim 29, wherein the step for securing the drug formulation comprises the steps for:

impregnating a layer of fabric material with a boric acid, sodium salt; and

placing said fabric material in contact with said formulation, said formulation containing polyvinyl alcohol, to cause the drug formulation to solidify as a gel onto the fabric material.

31. The method of claim 30, wherein the step for isolating the drug formulation comprises the step for placing a heat sealable barrier film on top of the fabric material and sealing said barrier film to the tray and the fabric material.

32. The method of claim 31, wherein a portion of the barrier film is not sealed onto the tray in order to provide a leading edge for peeling.

33. The method of claim 29, wherein the temperature control component is a CHADD patch.

36. The method of claim 29, further comprising peeling both the drug formulation and temperature control component from the tray in a single action.

34. An integrated temperature control and dermal drug delivery system comprising:

an isolated temperature control component that selectively controls heat generated from oxygen exposure; and

an isolated drug formulation integrated with the isolated temperature control component.

35. The system of claim 34, further comprising a means for affixing the system to human skin.

37. A method for fabricating a dermal drug delivery system having a selectively controllable heating component that generates heat upon exposure to oxygen, the method comprising the steps for:

providing a selectively controllable heating component configured to generate heat when exposed to oxygen;

providing a drug delivery component comprising a formulation that includes at least one pharmaceutically active substance;

coupling said heating component with said drug delivery component; and

sealing either said heating component or said drug delivery component into a space completely enveloped by one or more materials that are substantially impermeable to moisture or alcohol.