Methods and compositions for treating hyperhidrosis
AssigneeTheravida, Inc.
InventorBenjamin F. McGraw, III
Life of this patent
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Abstract
Aspects of the disclosure include methods for treating hyperhidrosis in a subject with a composition including a muscarinic antagonist and a muscarinic agonist. In practicing methods according to certain embodiments, a therapeutically effective amount of a composition including a muscarinic antagonist or a pharmaceutically acceptable salt thereof and a muscarinic agonist or a pharmaceutically acceptable salt thereof is administered to a subject and is sufficient to reduce hyperhidrosis in the subject and to reduce a dry mouth side effect of the muscarinic antagonist. Compositions for practicing the subject methods are also described as well as dose units containing one or more of the subject compositions.
Claims31
A method of treating hyperhidrosis in a subject in need thereof, the method comprising:
- orally administering to the subject once per day or twice per day a single unit dose of a therapeutically effective amount of a composition comprising
- an immediate release formulation of about 5 mg to 20 mg of oxybutynin or a pharmaceutically acceptable salt thereof and
- a delayed-immediate release formulation of about 5 mg to 20 mg of pilocarpine, or a pharmaceutically acceptable salt thereof, comprising a plurality of delayed-immediate release pilocarpine beads, wherein each pilocarpine bead comprises:
- a core;
- a first layer comprising pilocarpine or a pharmaceutically acceptable salt thereof positioned over the core;
- and
- a second layer comprising at least one polymer positioned over the first layer, and
- wherein the composition is administered to provide to the subject a total daily amount of from about 5 mg to about 20 mg of oxybutynin or a pharmaceutically acceptable salt thereof and a total daily amount of from about 5 mg to about 30 mg of pilocarpine or a pharmaceutically acceptable salt thereof.
A method of treating hyperhidrosis in a subject in need thereof, the method comprising:
- orally administering to the subject once per day or twice per day a single unit dose of a therapeutically effective amount of a composition comprising
- an immediate release formulation of about 5 mg to 20 mg of oxybutynin or a pharmaceutically acceptable salt thereof;
- and
- a delayed-immediate release formulation of about 5 mg to 20mg of pilocarpine, or a pharmaceutically acceptable salt thereof, comprising a plurality of delayed-immediate release pilocarpine beads, wherein each pilocarpine bead comprises:
- a core;
- a first layer comprising pilocarpine or a pharmaceutically acceptable salt thereof positioned over the core;
- and
- a second layer comprising at least one polymer positioned over the first layer,
- wherein the composition is administered to provide to the subject a total daily amount of from about 5 mg to about 20 mg of oxybutynin or a pharmaceutically acceptable salt thereof and a total daily amount of from about 5 mg to about 30 mg of pilocarpine or a pharmaceutically acceptable salt thereof, and
- wherein the composition is formulated such that the peak plasma concentration of oxybutynin or a pharmaceutically acceptable salt thereof and the peak plasma concentration of pilocarpine or a pharmaceutically acceptable salt thereof in the subject occurs at approximately the same time.
A method of treating hyperhidrosis in a subject in need thereof, the method comprising:
- orally administering to the subject once per day or twice per day a single unit dose of a therapeutically effective amount of a composition comprising
- an immediate release formulation of oxybutynin or a pharmaceutically acceptable salt thereof, wherein the oxybutynin or a pharmaceutically acceptable salt thereof is present in the composition in an amount from 5 mg to 10 mg;
- and
- a plurality of delayed-immediate release pilocarpine beads, wherein each pilocarpine bead comprises:
- a core, wherein the core is about 15% w/w to about 40% w/w, relative to the total weight of the bead;
- a first layer comprising pilocarpine or a pharmaceutically acceptable salt thereof positioned over the core, wherein the first layer is about 5% w/w to about 30% w/w, relative to the total weight of the bead, wherein the pilocarpine or a pharmaceutically acceptable salt thereof is present in the composition in an amount from 5 mg to 20 mg;
- and
- a second layer comprising hydroxypropylcellulose and ethylcellulose positioned over the first layer, wherein the second layer is about 40% w/w to about 70% w/w, relative to the total weight of the bead.
Dependencies are inferred from the claim text.