Method and devices for transdermal delivery of lithium
OwnerCharles B. Nemeroff, Clinton D. Kiltsinventors
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Abstract
A method and device for treating acute mania or bipolar disorder is disclosed, by transdermal delivery of Li+ at substantially constant rate through the skin via a dermal patch.
Claims36
A method for administering lithium at a substantially constant rate without causing significant pain or tissue damage to a human patient in need thereof, which method comprises:
- (a) providing a source of iontophoretically deliverable lithium;
- and
- (b) iontophoretically delivering Li+ to said patient.
A method of treating in humans acute mania or bipolar (manic/depressive) disorder comprising the steps of
- (a) topically applying to the skin of a patient in need of such treatment a transdermal delivery system comprising a source of lithium, and
- (b) delivering an effective amount of lithium ion to the patient's bloodstream.
A dermal patch for administering lithium to a human patient at substantially constant rate without causing significant pain or tissue damage, which patch comprises:
- a source of lithium for iontophoretic delivery;
- a support for said lithium source;
- a current distribution member for delivering a pulsed direct current sufficient to iontophoretically deliver lithium across a stratum corneum layer of the epidermis of said human, said current distribution member comprising an electrochemically active component in electrical connection with a battery, a voltage pulse generator and a precision resistor;
- and
- a detoxification or neutralization effective amount of a complexing agent selected from EDTA or EGTA or pharmaceutically acceptable salts thereof;
- wherein the lithium source is unbuffered;
- and
- wherein the patch is substantially free of any skin permeability enhancers.
A method of treating acute mania or bipolar (manic/depressive) disorder with lithium, by providing and maintaining blood Li+ concentrations of between about 0.6 and about 1.4 mEq/L in humans in need thereof, which method comprises the steps of
- (a) providing a dermal patch for administering lithium to a patient at substantially constant rate;
- (b) attaching the patch to the patient's skin;
- (c) iontophoretically delivering Li+ from said patch to the patient.
A method of treating acute mania or bipolar (manic/depressive) disorder with lithium, by providing and maintaining blood Li+ concentrations of between about 0.6 and about 1.4 mEq/L in humans in need thereof, which method comprises the steps of:
- (a) providing a dermal patch for administering lithium to a patient at substantially constant rate without causing significant pain or tissue damage;
- (b) attaching the patch to the patient's skin;
- (c) iontophoretically delivering Li+ from said patch to the patient;
- wherein the dermal patch for administering lithium to a patient at substantially constant rate comprises:
- a source of lithium for iontophoretic delivery;
- a support for said lithium source;
- a current distribution member for delivering a pulsed direct current sufficient to iontophoretically deliver lithium across a stratum corneum layer of the epidermis of said human, said current distribution member comprising an electrochemically active component in electrical connection with a battery, a voltage pulse generator and a precision resistor;
- and
- a detoxification or neutralization effective amount of a complexing agent selected from the group consisting of EDTA, EOTA, and pharmaceutically acceptable salts thereof;
- wherein the patch lithium source is unbuffered, and
- wherein the patch is substantially free of skin permeability enhancers.
A dermal patch for administering lithium to a human patient at substantially constant rate without causing significant pain or tissue damage, which patch comprises:
- a source of lithium for iontophoretic delivery;
- a support for said lithium source;
- a current distribution member for delivering a pulsed direct current sufficient to iontophoretically deliver lithium across a stratum corneum layer of the epidermis of said human, said current distribution member comprising an electrochemically active component in electrical connection with a battery, a voltage pulse generator and a precision resistor.
Dependencies are inferred from the claim text.