Apparatus and methods for improved noninvasive dermal administration of pharmaceuticals
First Claim
1. An apparatus for enhancing dermal absorption of pharmaceutical(s) comprising:
- a hollow frame having a first open end and a second open end;
a non-permeable wall disposed between said hollow frame'"'"'s first and second open ends;
a first chamber defined by said hollow frame, said non-permeable wall, and said hollow frame first open end;
a second chamber defined by said hollow frame, said non-permeable wall, and said hollow frame second open end, said second chamber configured for housing a pharmaceutically active formulation; and
a heating element for heating the user'"'"'s skin and regulating the temperature thereof, said heating element comprising a heat-generating means disposed within said first chamber.
10 Assignments
0 Petitions
Accused Products
Abstract
An apparatus, product formulation, and method for improved dermal permeation of pharmaceuticals wherein the apparatus includes a thin drug formulation reservoir and a heat-generating chamber separated by a first non-permeable wall, wherein the reservoir and chamber are formed in or supported by a housing. The drug formulation reservoir houses or is capable of housing a predetermined amount of a formulation containing pharmaceutically-active agent(s). The heat-generating/temperature-regulating chamber includes a medium for generating controlled heat, preferably a chemical composition made of carbon, iron, water and/or salt which is activated upon contact with air (oxygen). The function of the heat-generating/temperature-regulating element is to heat the user'"'"'s skin, rapidly bring the skin temperature to a desired and elevated narrow range and keep it in this range for sufficient time to obtain more rapid, enhanced and less variable dermal absorption of selected pharmaceutically-active agents and to obtain improved clinical effects. Structure for controlling the generation of heat is also disclosed. The apparatus may optionally include a spacing or standoff structure which spans the drug formulation reservoir between the non-permeable wall and the user'"'"'s skin surface for maintaining a predetermined thickness of the drug formulation on the user'"'"'s skin surface. Also, a novel product formulation which can be used with the apparatus which uses high percentage of eutectic mixture of local anesthetics to reduce the overall degradation rate of the local anesthetic compound(s) in formulations which are subject to hydrolysis.
-
Citations
51 Claims
-
1. An apparatus for enhancing dermal absorption of pharmaceutical(s) comprising:
-
a hollow frame having a first open end and a second open end; a non-permeable wall disposed between said hollow frame'"'"'s first and second open ends; a first chamber defined by said hollow frame, said non-permeable wall, and said hollow frame first open end; a second chamber defined by said hollow frame, said non-permeable wall, and said hollow frame second open end, said second chamber configured for housing a pharmaceutically active formulation; and a heating element for heating the user'"'"'s skin and regulating the temperature thereof, said heating element comprising a heat-generating means disposed within said first chamber. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
-
-
15. An apparatus for enhancing dermal absorption of pharmaceutical(s) comprising:
-
a hollow frame of flexible foam which is substantially deformable to conform to an irregular or non-planar surface, said hollow frame having a first open end and a second open end; a non-permeable wall disposed between said hollow frame first and second open ends; a first chamber defined by said hollow frame, said non-permeable wall, and said hollow frame first open end; a second chamber defined by said hollow frame, said non-permeable wall, and said hollow frame second open end said second chamber configured for housing a pharmaceutically active formulation; a heating element for heating the user'"'"'s skin and regulating the temperature thereof into a desired and elevated range for a desired length of time, said heating element comprising a heat-generating medium disposed within said first chamber and being a composition made of carbon, iron, water, salt, or a combination thereof which is activated upon contact with ambient air; said hollow frame first open end being capped with a structure for controlling ambient air contact with said heat-generating medium, said structure comprising an opening(s) or area(s) of said cap comprising a membrane with desired permeability to air; spacing means disposed between said non-permeable wall and said hollow frame second open end for substantially maintaining a predetermined depth between said non-permeable wall and said hollow frame second open end, said spacing means selected from a group comprising a grid, parallel baffles, concentric circles, pins, posts, or a 3-D sponge matrix which substantially maintains a predetermined depth between said non-permeable wall and said hollow frame second open end while still allowing said pharmaceutically-active formulation to reside within said second chamber; and means for adhering said frame to the skin of a user with said hollow frame second open end in contact therewith.
-
-
16. A method for enhancing dermal absorption of pharmaceutical(s) comprising:
- providing a patch comprising;
a) a hollow frame having a first open end and a second open end; b) a non-permeable wall disposed between said hollow frame'"'"'s first and second open ends; c) a first chamber defined by said hollow frame, said non-permeable wall, and said hollow frame first open end; d) a second chamber defined by said hollow frame, said non-permeable wall, and said hollow frame second open end said second chamber configured for housing a pharmaceutically active formulation; and e) a medium for heating and regulating the temperature of a user'"'"'s skin, said heat-generating medium disposed within said first chamber; inserting a predetermined amount of pharmaceutically-active formulation into said second chamber, either during the fabrication of said patch or immediately prior to use thereof; activating said heating medium; affixing said patch to said user'"'"'s skin such that said pharmaceutically-active formulation is in direct contact therewith; and allowing said patch to remain on said user'"'"'s skin for a predetermined duration of time. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
- providing a patch comprising;
-
27. An apparatus for facilitating enhanced dermal absorption of pharmaceutical(s), comprising:
-
a housing defining first and second superimposed, substantially laterally coextensive predominantly two-dimensional chambers separated by a wall; a heating and temperature-regulating element comprising said first chamber containing a heat-generating medium; and said second chamber for containing a pharmaceutically-active formulation. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37)
-
-
38. A method of facilitating enhanced dermal absorption of pharmaceutically-active agent(s), comprising:
-
providing a quantity of a selected pharmaceutically-active formulation; applying said formulation to the skin of a patient over a selected two-dimensional area thereof; and generating heat substantially over said two-dimensional area of said skin with said formulation interposed between said heat and said skin. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45)
-
-
46. An apparatus for facilitating enhanced dermal absorption of pharmaceutical(s), comprising:
-
a housing defining predominantly two-dimensional chamber; a heating and temperature-regulating element comprising said chamber containing a heat-generating medium; and structure for affixation of said housing over the skin of a user over a separate drug delivery system. - View Dependent Claims (47, 48, 49, 50, 51)
-
Specification