Methods and apparatus for improved administration of fentanyl and sufentanil

• US 6,284,266 B1
• Filed: 09/29/1998
• Issued: 09/04/2001
• 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): Williamson, Michael A.
• Application Number:
  US09/162,587
• Time in Patent Office: 1,071 Days
• Field of Search: 424/402, 424/443, 424/447, 424/448, 424/449, 602/41, 602/46
• US Class Current: 424/449
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
• 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 7/02 Compresses or poultices for effecting heating or cooling
• 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
• CPC Class Codes: A61P 29/02 without antiinflammatory effect

Abstract

Methods and apparatus for improving administration of analgesics through the use of heat. The present invention relates to the use of heat in conjunction with specially designed transdermal analgesic delivery systems and conventional commercial transdermal analgesic delivery systems to alter, mainly increase, the analgesic release rate from the transdermal analgesic delivery systems or the depot sites to accommodate certain clinical needs.

Claims

1. A method of controlling the rate of analgesic delivery to a systemic circulation of a human body comprising:

applying a transdermal analgesic delivery system to the skin of said human body for delivery of an analgesic to said systemic circulation of said human body;

applying a temperature modification apparatus capable of generating controlled heat proximate said transdermal analgesic delivery system by exposing an oxygen activated exothermic medium within the apparatus to oxygen and varying the amount of oxygen to which the exothermic medium is exposed to vary a rate of reaction of the exothermic medium; and

heating said skin of said human body proximate said transdermal analgesic delivery system with said temperature modification apparatus to achieve an increased rate of delivery of analgesic to said systemic circulation of said human body.

2. The method of claim 1, wherein said applying said temperature modification apparatus capable of generating heat proximate said transdermal analgesic delivery system comprises applying said temperature modification apparatus to said transdermal analgesic delivery system.

3. The method of claim 1, wherein said heating said transdermal analgesic delivery system includes heating said skin of said human body proximate said transdermal analgesic delivery system up to a temperature of about 60°

C.

4. The method of claim 1, wherein said heating said skin of said human body effectuates an increase in said rate of analgesic delivery to said systemic circulation of said human body through increasing skin permeability by said heating.

5. The method of claim 1, wherein said heating said skin of said human body effectuates an increase in said rate of analgesic delivery to said systemic circulation of said human body through increasing the permeability of blood vessel walls in sub-skin tissues by said heating.

6. The method of claim 1, wherein said heating said skin of said human body effectuates an increase in said rate of analgesic delivery to said systemic circulation of said human body through driving said analgesic in depot sites in tissues under said transdermal analgesic delivery system into the systemic circulation at faster rates by said heating.

7. The method of claim 1, wherein said heating said skin of said human body effectuates an increase in said rate of analgesic delivery to said systemic circulation of said human body through increasing circulation of body fluid in tissues proximate said transdermal analgesic deliver system by said heating.

8. The method of claim 1, wherein said applying said temperature modification apparatus proximate said transdermal administered analgesic comprises applying said temperature modification apparatus proximate said temperature when breakthrough pain occurs.

9. The method of claim 8, further including discontinuing temperature adjustment when said breakthrough pain diminishes.

10. The method of claim 1, further including discontinuing said heating of said skin of said human body with said temperature modification apparatus when a desired clinical effect in said human body is achieved.

11. The method of claim 1, further including removing said temperature modification apparatus when a desired clinical effect in said human body is achieved.

12. The method of claim 1, further including terminating said heating said skin with a heat termination mechanism after a pre-determined duration of time.