Electrical apparatus for heating to a desired temperature for improved administration of pharmaceutically active compounds

• US 6,613,350 B1
• Filed: 04/07/2000
• Issued: 09/02/2003
• Est. Priority Date: 07/28/1995
• Status: Expired due to Fees

• Current Assignee: Zars, Inc.
• Original Assignee: Zars, Inc.
• Inventors: Zhang, Hao, Zhang, Jie
• Primary Examiner(s): Dodson, Shelley A.
• Application Number:
  US09/544,897
• Time in Patent Office: 1,243 Days
• Field of Search: 724/449, 724/402, 724/447, 724/448, 524/817, 524/937, 524/944, 602/41, 602/46
• US Class Current: 424/449
• 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

Methods and apparatus for improving administration of drugs through the use of heat and other physical means. The present invention relates to the use of heat and other physical means in conjunction with specially designed dermal drug delivery systems, conventional commercial dermal drug delivery systems, or drugs delivered into a sub-skin depot site via injection and other methods to alter, mainly increase, the drug release rate from the dermal drug delivery systems or the depot sites to accommodate certain clinical needs.

Claims

1. A controlled heat generating apparatus configured to selectively provide heat in a desired, narrow temperature range for a desired length of time, the apparatus comprising:

a heating unit capable of generating heat when supplied with electricity wherein said heating unit includes a temperature feedback system; and

a substantially two-dimensional surface coupled to said heating unit and configured to pass said heat to at least one of;

(i) a dermal drug delivery system; and

(ii) a patient'"'"'s skin.

2. The controlled heat generating apparatus of claim 1, wherein said dermal drug delivery system is in contact with said patient'"'"'s skin.

3. The controlled heat generating apparatus of claim 1, wherein said substantially two-dimensional surface is configured to pass heat when said surface is in contact with an area of said patient'"'"'s skin and said skin was previously in contact with said dermal drug delivery system.

4. The controlled heat generating apparatus of claim 1, wherein said substantially two-dimensional surface is configured to pass heat when said surface is in contact with an area of said patient'"'"'s skin under which a storage site exists.

5. The controlled heat generating apparatus of claim 1, wherein said substantially two-dimensional surface is configured to pass said heat to a rate limiting membrane and a pharmaceutical formulation dispersed within said dermal drug delivery system.

6. The controlled heat generating apparatus of claim 1, wherein said temperature range is a range below 60°

centigrade.

7. The controlled heat generating apparatus of claim 1, wherein said desired length of time is between about 3 minutes and about 7 days.

8. The controlled heat generating apparatus of claim 1, further comprising a temperature sensor coupled to said temperature feedback system.

9. The controlled heat generating apparatus of claim 8, wherein said sensor is configured to be selectively coupled to at least one of:

(i) said dermal drug delivery system; and

(ii) said patient'"'"'s skin.

10. In a system that includes a dermal drug delivery system and a heating unit configured to generate heat when supplied with electricity, a method for improving an administration of a pharmaceutical formulation through a patient'"'"'s skin, the method comprising the steps for:

using the electrical heating unit to selectively generate heat;

using a two-dimensional surface of the electrical heating unit to pass the heat to a receiving surface; and

employing a temperature feedback system to regulate an amount of heat passed to the receiving surface

11. The method of claim 10, wherein the receiving surface comprises at least one of:

(i) the dermal drug delivery system; and

(ii) a patient'"'"'s skin.

12. The method of claim 11, wherein the step for employing a temperature feedback system includes the step for using a temperature sensor to monitor a temperature at the receiving surface.

13. The method of claim 12, wherein the step for employing a temperature feedback system includes the step for transmitting a signal based on the temperature monitored to a controller that regulates an amount of heat generated by the electrical heating unit.

14. The method of claim 13, further comprising the step for securing the electrical heating unit to the patient'"'"'s skin.

15. The method of claim 10, wherein the receiving surface comprises one of:

(i) a rate limiting membrane and pharmaceutical formulation disposed in the dermal drug delivery system;

(ii) healing skin of the patient; and

(iii) a storage site located under a layer of skin.

16. The method of claim 10, further comprises the step for selectively passing the heat to facilitate transdermal absorption of a pharmaceutical formulation into the patient.

17. The method of claim 16, wherein the step for selectively passing further comprises the step for passing the heat to increase a solubility of an active ingredient in a pharmaceutical formulation dispersed within the dermal drug delivery system into the patient.

18. The method of claim 10, further comprising the step for maintaining a temperature range at the receiving surface below 60°

centigrade.

19. An electrical heating apparatus kit configured to selectively heat a patient'"'"'s skin in an area associated with a dermal drug delivery system, the kit comprising:

a dermal drug delivery system configured to selectively deliver a predetermined amount of a pharmaceutical formulation to a patient; and

an electrical heat generating unit having a feedback mechanism to selectively provide an amount of heat to at least one of;

(i) the dermal drug delivery system; and

(ii) the area of the patient'"'"'s skin associated with the dermal drug delivery system.

20. The electrical heating apparatus kit of claim 19, further comprising a temperature sensor configured to selectively monitor the amount of heat provided.