Methods and apparatus for improved administration of testosterone pharmaceuticals
First Claim
1. A method of increasing the delivery rate of an androgen transdermal therapeutic system through skin to correspond to a natural circadian pattern, the method comprising:
- applying an androgen transdermal therapeutic system to the skin for delivery of androgen;
applying an apparatus capable of generating heat proximate the androgen transdermal therapeutic systems and configured to create heat in a manner that mimics the endogenous circadian androgen production; and
heating the androgen transdermal therapeutic system with the apparatus capable of generating heat at a safe, pre-designed temperature for a safe, pre-designed length of time to achieve an increased rate of delivery of androgen through the skin to simulate to a natural circadian pattern.
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Abstract
The present invention relates to a method and apparatus for increasing the delivery rate of an androgen transdermal therapeutic system through the skin. An androgen transdermal therapeutic system can be applied to a patient'"'"'s skin for delivery of the androgen. A temperature modification apparatus which is capable of generating controlled heat is applied approximate to the androgen transdermal therapeutic system. The heating from the temperature modification apparatus raises the temperature of the androgen transdermal therapeutic system and raises the temperature of the patient'"'"'s skin to achieve an increased rate of delivery of androgen through the skin. The controlled heat can also be used to adjust dosage rates of the androgen transdermal therapeutic system and to mimic natural circadian patterns. The controlled heating may also be used to improve or regulate the release of androgen from injected/implanted extended/controlled release systems.
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Citations
58 Claims
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1. A method of increasing the delivery rate of an androgen transdermal therapeutic system through skin to correspond to a natural circadian pattern, the method comprising:
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applying an androgen transdermal therapeutic system to the skin for delivery of androgen;
applying an apparatus capable of generating heat proximate the androgen transdermal therapeutic systems and configured to create heat in a manner that mimics the endogenous circadian androgen production; and
heating the androgen transdermal therapeutic system with the apparatus capable of generating heat at a safe, pre-designed temperature for a safe, pre-designed length of time to achieve an increased rate of delivery of androgen through the skin to simulate to a natural circadian pattern. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of reducing the time it takes to achieve a desired, increased concentration of a target androgen in a systemic circulation of a human body comprising:
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applying an androgen transdermal therapeutic system to the skin of the human body for delivery of therapeutic androgen to the systemic circulation of the human body;
applying a temperature control apparatus capable of generating heat proximate the androgen transdermal therapeutic system and configured to create heat in a manner that mimics the endogenous circadian androgen production; and
heating the skin under the androgen transdermal therapeutic systems with the temperature control apparatus to reduce the time it takes to achieve a desired increased concentration of the target androgen in the systemic circulation of the human body. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
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47. A method for adjusting a rate of androgen delivery from an androgen transdermal therapeutic system through the skin to mimic a natural circadian pattern, the method comprising:
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placing an androgen transdermal therapeutic system on the skin applying a temperature control apparatus configured to create heat in a manner that mimics the endogenous circadian androgen production;
heating the skin under said androgen transdermal therapeutic system to a safe, predetermined temperature range for a safe, predesigned length of time; and
terminating said heating after the predesigned length of time to mimic the natural circadian pattern. - View Dependent Claims (48, 49, 50, 51)
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52. A method for obtaining varying serum androgen release rates into the systemic circulation of the human body that correspond to a natural circadian pattern from otherwise substantially constant release delivery systems injected or implanted in said human body, the method comprising:
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administering a controlled/extended release androgen therapeutic system in a target site within 3 cm from the skin surface, applying a control heating apparatus on the skin proximate to the target site configured to create heat in a manner that mimics the endogenous circadian androgen production; and
heating the androgen therapeutic system to a safe, predesigned temperature for a safe, predesigned length of time to correspond to the natural circadian pattern. - View Dependent Claims (53, 54, 55, 56, 58)
a chamber defined by a bottom wall, a top wall and side walls, the bottom wall, top wall and side walls of the chamber being made of flexible substantially air impermeable material, the air impermeable material defining at least one hole through material, and a temperature regulating mechanism disposed within the chamber, the temperature regulating mechanism comprising reactants capable of creating an exothermic oxidation reaction when exposed to oxygen. -
56. The apparatus as in claim 55, wherein the temperature regulating mechanism comprises a mixture of activated carbon, iron powder, and water.
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58. The method of claim 55, where in the desired period of time is in the range of about 1-10 hours and the step of administering the patch is done in the morning to properly mimic the patient'"'"'s natural circadian pattern.
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57. A method of mimicking a variation of testosterone concentrations in the blood of the human body according to a natural circadian pattern, the method comprising the steps of:
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administrating an integrated patch capable of delivering androgen and capable of delivering controlled heat in a manner that mimics the endogenous circadian androgen production to the skin of a patient;
elevating the patient'"'"'s skin temperature proximate to the integrated patch to a safe, predesigned temperature for a safe, predesigned length of time using controlled heat, thereby allowing increased absorption of androgen that human body according to the natural circadian pattern; and
maintaining said increased absorption by said controlled heat for the predesigned length of time.
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Specification