Reduction of skin irritation during electrotransport
First Claim
1. In a method of operating an electrotransport delivery device which delivers an agent by electrotransport under the influence of an electric current through a skin site, the device comprising an anodic electrode assembly, a cathodic electrode assembly, a source of electrical power electrically connected to the electrode assemblies and an agent reservoir in at least one of the electrode assemblies;
- the improvement whereby electrotransport-induced irritation of the skin site can be reduced or avoided;
which improvement comprises;
a) monitoring potassium concentration in the cathodic electrode assembly during electrotransport agent delivery; and
b) reducing the electric current flowing through the skin site when the potassium concentration reaches a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin.
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Accused Products
Abstract
An electrotransport delivery device utilizing reservoir buffering at a select pH ranges in order to reduce skin irritation and skin resistance is provided. Cathodic reservoirs are buffered to a pH of less than about 4, preferably to a pH in the range of about 2 to 4, while anodic reservoirs are buffered to a pH above about 4, preferably to a pH in the range of about 4 to 10. Another electrotransport delivery device utilizes a potassium sensor to monitor potassium efflux from the skin. Potassium efflux above a certain predetermined level has been found to be a precursor to skin irritation/erythema. Operation of the device is modified (eg, terminated) when the predetermined potassium efflux level is sensed.
130 Citations
15 Claims
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1. In a method of operating an electrotransport delivery device which delivers an agent by electrotransport under the influence of an electric current through a skin site, the device comprising an anodic electrode assembly, a cathodic electrode assembly, a source of electrical power electrically connected to the electrode assemblies and an agent reservoir in at least one of the electrode assemblies;
the improvement whereby electrotransport-induced irritation of the skin site can be reduced or avoided;
which improvement comprises;a) monitoring potassium concentration in the cathodic electrode assembly during electrotransport agent delivery; and b) reducing the electric current flowing through the skin site when the potassium concentration reaches a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising:
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a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal alerting the patient when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin. - View Dependent Claims (9)
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10. An electrotransport device for delivering an agent through a skin site under the influence of an electrical current, said device being capable of reducing irritation associated with such delivery, said device comprising:
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a) an anodic electrode assembly and a cathodic electrode assembly; b) an agent reservoir in at least one of said electrode assemblies; c) a source of electrical power electrically connected between said electrode assemblies whereby an electrical current can be caused to flow between said electrode assemblies through said agent reservoir and said skin site; d) means for monitoring the concentration of potassium in said cathodic electrode assembly during electrotransport administration of said agent; and e) means for emitting a signal to a controller when said monitoring means detects an increase in the potassium concentration to a value which corresponds to a predetermined potassium efflux level associated with electrotransport-induced irritation of the skin; f) a controller for reducing the electric current applied by the device in response to receiving said signal. - View Dependent Claims (11, 12, 13, 14, 15)
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Specification