Claims for Patent: 6,780,426

Summary for Patent: 6,780,426

Title:	Method and apparatus for improved heat controlled administration of pharmaceuticals
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.
Inventor(s):	Zhang; Jie (Salt Lake City, UT), Zhang; Hao (Salt Lake City, UT)
Assignee:	Zars, Inc. (Salt Lake City, UT)
Application Number:	10/307,091
Patent 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-determined 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 beating 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.