Devices and methods for heat-pulse assisted thermal applications of active subtances

• US 20040219192A1
• Filed: 09/23/2003
• Published: 11/04/2004
• Est. Priority Date: 01/23/2001
• Status: Abandoned Application

• Current Assignee: Michael Hortsmann
• Original Assignee: Michael Hortsmann
• Inventors: Horstmann, Michael, Bracht, Stefan
• Application Number:
  US10/470,017
• Publication Number:
  US 20040219192A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• 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 9/7023 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

Abstract

The invention relates to devices for administering heat pulses to the skin, and for heat pulse-promoted transdermal administration of active substances, said device having one or more electric heating elements and a source of current as well as a control unit, the said control unit being suitable for causing a pulse-like heating of the said heating element.

Claims

1. Device for heat pulse-supported transdermal administration of active substances, comprising

a transdermal therapeutic system (TTS), having a backing layer, an active substance-containing reservoir and, on the side facing the skin, an active substance-permeable electric heating element or a plurality of such elements,

and a control unit, connected to said heating element, and a current source, said control unit being suitable for causing pulse-like heating of said heating element.

3. Device according to claim 1, characterized in that the heating of the heating element/heating elements takes place in the temperature range of between 40°

C. to 200°

C., preferably in the range of between 50°

C. and 120°

C., and that the duration of the heat pulses is 0.1 to 2 seconds, preferably 0.2 to 1 s, the temperature and/or the duration of the heat pulses being preset by the control unit, or being controllable.

4. Device according to claim 1, characterized in that it produces the said heat pulses repeatedly, the length of the time intervals between the individual heat pulses being at least 0.01 s, preferably 0.1 s to 100 s, with particular preference 1 to 60 s, and the duration of these time intervals being preset or controllable by the control unit.

5. Device according to claim 1, characterized in that as a source of current, one or more galvanic battery/batteries or one or more accumulator(s), preferably selected from the group of the nickel-cadmium accumulators, nickel-metal hydride (NiMH) accumulators, lithium ion accumulators and lithium batteries, or one or more capacitor(s), is/are used, the electric capacitance in the case of accumulators preferably being 0.1 to 10 Ah at voltages of from 1.2 to 24 V, and in the case of capacitors in the same voltage range, preferably 0.01 to 10 F.

6. Device according to claim 1, characterized in that the heating element is sheet-like or layer-shaped and preferably is a thin, sheet-like metal film or made up of a plurality of such individual film surfaces, the said metal film preferably being made of a metal selected from the group comprising copper, tin, aluminium:

and other soft metals as well as alloys of the said metals.

7. Device according to claim 6, characterized in that the heating element is made up of individual, thin, sheet-like metal films, with metal film resistors preferably being used as the metal films.

8. Device according to claim 6, characterized in that the metal film is provided with perforations, holes or slots, or that it is configured like a lattice, or is divided into a plurality of strips lying next to one another.

9. Device according to claim 1, characterized in that as the heating element a flat-shaped winding of a thin wire, or a plurality of such windings, is used, the said wire preferably being made of a metal selected from the group comprising copper, tin, aluminium and other soft metals, as well as alloys of the said metals.

10. Device according to claim 1, characterized in that the heating element consists substantially of an electrically conductive plastics film, or of a plurality of individual surface parts of such films, with a polymer film high-enriched with carbon powder being used with preference.

11. Device according to claim 1, characterized in that the control unit is provided with a speed controller, a BEC control circuit board, as well as a pulse generator.

12. Device according to claim 1, characterized in that during a pulse length of 0.01 to 0.5 s, preferably from 0.05 to 0.1 s, it generates current intensities in the range of from 1 to 100 A, preferably from 5 to 20 A, at an applied voltage of 1.2 to 24 V, preferably from 1.2 to 7.2 V.

13. Use of a device according to claim 1 for topical or transdermal administration of medicaments or other active substances for the purpose of therapeutic or cosmetic treatment of humans or animals.

2. Device for administration of heat pulses to human or animal skin, comprising

a pressure-sensitive adhesive medicinal patch;

one or more electric heating element(s) connected with the patch;

and a control unit, connected with said heating element(s), and a current source, said control unit being suitable for effecting pulse-like heating of the said heating element.

14. Process for topical or transdermal administration of active substances to human or animal skin wherein one or more active substances are released from an active substance reservoir of a transdermal therapeutic system, and are delivered to the skin, characterized in that, during the period of application, the application site is heated in a pulsed manner to improve active substance permeation, with a temperature of at least 40°

C. being reached.

17. Process according to claim 14, characterized in that the pulse-like heating of the application site is brought about by an electric heating element, or a plurality of such elements, which is/are in contact with the skin during the period of application, the said heating element being connected with a source of current and a control unit.

18. Process according to claim 14, characterized in that the pulse-like heating takes place in the temperature range of between 40°

C. and 200°

C., preferably in the range between 50°

C. and 120°

C., and that the duration of the heat pulses is 0.1 to 2 seconds, preferably 0.2 to 1 s.

19. Process according to claim 14, characterized in that the pulse-like heating is performed repeatedly, with the length of the time intervals between the individual heat pulses being at least 0.01 s, preferably 0.1 to 100 s, with particular preference 1 to 60 s.

20. Process according to claim 14, characterized in that the temperature or temperature range reached during the pulse-like heating, and/or the duration of the individual heat pulses, and/or the length of the time intervals between the individual heat pulses, and/or the total number of heat pulses, and/or the maximum total duration of the treatment with heat pulses, are each preset or subsequently altered or adjusted by a control device connected with the heating element or heating elements and the source of current.

21. Process according to claim 14, characterized in that the heat pulses are generated by current intensities in the range of from 1 to 100 A, preferably from 5 to 20 A, at an applied voltage of from 1.2 to 24 V, preferably 1.2 to 7.2 V, during a pulse length of from 0.01 to 0.5 s, preferably from 0.05 to 0.1 s.

15. Process for topical or transdermal administration of active substances to human or animal skin, characterized in that

in a first step, the active substance(s) is/are applied to an area of skin in the form of an active substance preparation, and

in a second step, a device is applied to the above-mentioned skin area by means of which the application site is heated in a pulsed manner during the period of application in order to improve active substance permeation, with a temperature of at least 40°

C. being reached.

16. Process according to claim 15, characterized in that the second step is performed at a distance in time of 10 s to 24 h, preferably 1 min to 1 h, after the first step.

22. (cancelled)