Bodor Laboratories, Inc.

David Angulo

Nicholas S Bodor

John Joseph Koleng, Jr

Topical formulations comprising soft glycopyrrolates are useful for treating excessive sweating conditions in subjects, such as humans suffering from hyperhidrosis. Preferably, at least one soft anticholinergic agent is provided in an effective amount or concentration in an anhydrous formulation that can inhibit excessive perspiration resulting from a condition such as hyperhidrosis.

Formulation for soft anticholinergic analogs

A method of treating hyperhidrosis in a mammalian subject, said method comprising topically administering a composition comprising a compound having the formula (I): wherein R is methyl or ethyl, said compound having the R stereoisomeric configuration at the 2 position and the R, S, or RS stereoisomeric configuration at the 1' and 3&#x2032; position, or being a mixture thereof; in an amount of from about 1.0% to about 25% of said compound, an additional active substance that is an antiperspirant active substance and, optionally, a pharmaceutically acceptable vehicle, to skin of an area of a mammalian subject suffering from hyperhidrosis in a one to four times daily dosing regimen.

Method of dosing and use of soft anticholinergic esters

The subject application is directed to a method of treating hyperhidrosis in a mammalian subject comprising topically administering a composition comprising a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound selected from the group consisting of: (i) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-(methoxycarbonylmethyl)-1-methylpyrrolidinium bromide; and (ii) 3-(2-cyclopentyl-2-phenyl-2-hydroxyacetoxy)-1-(ethoxycarbonylmethyl)-1-methylpyrrolidinium bromide; to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours; and such that sweat production is reduced by an amount substantially equivalent to an amount that sweat production is reduced as compared to untreated, baseline conditions, following administration of a composition comprising the same concentration of glycopyrrolate.

A method of treating hyperhidrosis in a mammalian subject including: a) providing a composition including a pharmaceutically acceptable vehicle and from about 1.0% to about 25% of a compound having the formula: and b) topically administering the composition to skin of an area of a mammalian subject suffering from hyperhidosis, before bedtime, such that, compared to untreated, baseline conditions, sweat production is reduced by at least about 25% for at least about six (6) hours.

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Tampa, FL, United States of America

David Angulo