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Claims for Patent: 6,546,281

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Claims for Patent: 6,546,281

Title: Integrated apparatus for controlled heat aided dermal drug delivery
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.
Inventor(s): Zhang; Jie (Salt Lake City, UT), Zhang; Hao (Midvale, UT), Hull; Wade A. (Taylorsville, UT), Rigby; Larry (Salt Lake City, UT)
Assignee: Zars, Inc. (Salt Lake City, UT)
Application Number:09/317,372
Patent 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.degree. and 45.degree. 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.

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.

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.

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.

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.

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

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.
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