Method and apparatus for improved heat controlled administration of pharmaceuticals

• US 20030138464A1
• Filed: 11/27/2002
• Published: 07/24/2003
• Est. Priority Date: 07/28/1995
• Status: Active Grant

• Current Assignee: Nuvo Research AG (Searchlight Pharma, Inc.)
• Original Assignee: Zars, Inc.
• Inventors: Zhang, Hao, Zhang, Jie
• Granted Patent: US 6,780,426 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• 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

The present invention features methods and apparatus'"'"'for improving administration of drugs through the use of specifically controlled 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 method of reducing an onset time of the effect of a drug in a target area of a human body comprising:

administering a drug to a portion if said human body;

applying a temperature of modification apparatus proximate said drug being administered, said temperature modification apparatus capable of generating controlled heat by exposing an oxygen activated exothermic medium within the apparatus to a safe, pre-determined amount of oxygen; and

heating the temperature of skin proximate said portion of said human body for a safe, pre-determined amount of time and within a safe, pre-determined temperature range, said temperature modification apparatus to achieve said reduced onset time of said drug in said targeted area.

2. A method of reducing the onset time of a drug in a targeted area of a human body comprising:

administering a drug to a portion of said human body, wherein said administering said drug is a method selected from the group consisting of transdermal application, application of a dermal drug delivery system, subcutaneous administration, and intramuscular administration;

applying an apparatus capable of generating heat proximate said drug being administered, said apparatus capable of generating controlled heat proximate said portion of said human body by exposing an oxygen activated exothermic medium within the apparatus to a safe, pre-determined amount of oxygen, thus heating the skin proximate said portion of said human body to a safe, pre-determined temperature and for a safe, pre-determined amount of time to achieve said reduced onset time of said drug.

3. A method of reducing the onset time of an analgesic in a targeted area of a human body comprising:

administering said analgesic into a site of said human body within about 3 centimeters from the surface of the skin proximate said site;

applying a temperature modification apparatus proximate said skin proximate said site, said temperature modification apparatus capable of generating controlled heat proximate said site of said administered analgesic by exposing an oxygen activated exothermic medium within the apparatus to a safe, pre-determined amount of oxygen, thus heating the skin proximate said portion of said human body to a safe, pre-determnined temperature and for a safe, pre-determined amount of time to achieve said reduced onset time of said analgesic.

4. A method of treating baseline and suddenly increased pain in a human body comprising:

administering an analgesic in a sustained release formulation into a portion of said human body to treat a baseline pain within 3 centimeter of a skin surface;

applying an apparatus capable of generating controlled heat for a pre-determined duration of time by exposing an oxygen activated exothermic medium within the apparatus to a safe, pre-determined amount of oxygen of the exothermic medium proximate said injected, sustained release analgesic at the onset of suddenly increased pain; and

increasing the temperature of skin proximate said portion of said human body to a safe, pre-determined temperature and for a safe, pre-determined amount of time with said apparatus to achieve a desired increased concentration of said analgesic in said human body.

5. An apparatus capable of heating to a safe, pre-determined temperature range for a safe, pre-determined amount of time, said apparatus comprising:

a shallow chamber defined by an air impermeable wall having an opening and a cover capable of covering said opening, said covering having a desired air permeability, and

a heat generating medium disposed within said shallow chamber of said apparatus, said apparatus capable of generating controlled heat by exposing an oxygen activated exothermic medium within the apparatus to a safe, pre-determined amount of oxygen.

6. A controlled heat generating apparatus configured to selectively provide heat at a safe, pre-determined temperature and for a safe, pre-determined amount of time, said 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.

7. In a system that includes a dermal drug delivery system and a heating unit configured to generate heat when supplied with electricity for a safe, pre-determined amount of time and between a safe, pre-determined temperature range, 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 between a safe, pre-determined temperature range and for a safe, pre-determined amount of time.

8. 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 pre-determined amount of a pharmaceutical formulation to a patient; and

an electrical heat generating unit having a feedback mechanism to selectively provide heat, regulated between a safe, pre-determined temperature range for a safe, pre-determined amount of time, 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.

9. A heating apparatus configured to selectively heat a patient'"'"'s skin in an area immediately surrounding and under a dermal drug delivery system, the heating apparatus comprising:

a dermal drug delivery system configured to be selectively placed in contact with a patient'"'"'s skin and to selectively deliver a pre-determined amount of a pharmaceutical formulation through the patient'"'"'s skin;

an infrared generating unit coupled to the dermal drug delivery system and configured to emit infrared radiation to selectively heat the patient'"'"'s skin between a safe, pre-determined temperature range for a safe, pre-determined amount of time;

a directing mechanism coupled to the infrared generating unit and configured to direct the infrared radiation onto at least one of

(i) the dermal drug delivery system, and

(ii) the patient'"'"'s skin; and

a temperature feedback mechanism coupled to the infrared generating unit for regulating the applied heat, wherein the temperature feedback mechanism includes a temperature sensor.

10. In a system that includes a dermal drug delivery system and an infrared generating unit, a method for improving an administration of a pharmaceutical formulation through a patient'"'"'s skin, the method comprising the steps for:

providing the dermal drug delivery system in contact with the patient'"'"'s skin, wherein the drug delivery system includes the pharmaceutical formulation;

using the infrared generating unit to emit infrared radiation to selectively heat the patient'"'"'s skin between a safe, pre-determined temperature range for a safe, pre-determined amount of time in an area immediately surrounding and under the drug delivery system;

using a temperature sensor and feedback mechanism to provide feedback to the infrared generating unit relating to a temperature of the pharmaceutical formulation; and

using the dermal drug delivery system to administer the pharmaceutical formulation to the patient through the patient'"'"'s skin.

11. A heating apparatus kit configured to selectively heat a patient'"'"'s skin in an area immediately surrounding and under a dermal drug delivery system, the kit comprising:

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

an infrared generating unit configured to emit infrared radiation to selectively heat the patient'"'"'s skin between a safe, pre-determined temperature range for a safe, pre-determined amount of time, wherein the infrared generating unit includes a temperature sensor and feedback mechanism.