US2016151321A1PendingUtilityA1

Methods for the treatment of sialorrhea

72
Individually held — no corporate assignee on recordPriority: Nov 13, 2012Filed: Nov 12, 2014Published: Jun 2, 2016
Est. expiryNov 13, 2032(~6.3 yrs left)· nominal 20-yr term from priority
Inventors:Dinesh C. Patel
A61K 9/7061A61K 9/2018A61K 31/216A61K 9/2009A61K 9/0056A61K 9/2054
72
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Claims

Abstract

The present invention provides safe and effective methods for the treatment of sialorrhea (excessive drooling) by administering an effective amount of N-desethyloxybutynin, or an optical R- or S-isomer thereof or a pharmaceutically acceptable salt thereof.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of treating sialorrhea in a subject comprising:
 providing a therapeutically effective amount of a N-desethyloxybutynin compound; and   non-parenterally administering the therapeutically effective amount of the N-desethyloxybutynin compound to the subject.   
     
     
         2 . The method of  claim 1 , wherein the N-desethyloxybutynin comprises (R)—N-desethyloxybutynin or a pharmaceutically acceptable salt thereof or (S)—N-desethyloxybutynin or a pharmaceutically acceptable salt thereof, or a combination thereof. 
     
     
         3 . The method of  claim 1 , wherein the N-desethyloxybutynin is administered via oral, buccal, transdermal, inhalation, implantation, vaginal or rectal route of administration. 
     
     
         4 . The method of  claim 1 , wherein the N-desethyloxybutynin is orally administered. 
     
     
         5 . The method of  claim 4 , wherein the oral administration is administered either transmucosally through the oral cavity or enterally, or by a combination thereof. 
     
     
         6 . The method of  claim 1 , wherein the N-desethyloxybutynin is administered as an immediate release dosage form. 
     
     
         7 . The method of  claim 1 , wherein the N-desethyloxybutynin is administered as a controlled release dosage form. 
     
     
         8 . The method of  claim 1 , wherein the amount of N-desethyloxybutynin is from about 1 mg to about 100 mg. 
     
     
         9 . The method of  claim 8 , where in the amount is from about 2 mg to about 30 mg of N-desethyloxybutynin. 
     
     
         10 . The method of  claim 1 , wherein the N-desethyloxybutynin is administered as an oral tablet, capsule, or liquid. 
     
     
         11 . A non-parenteral dosage form for administering N-desethyloxybutynin to a subject comprising a therapeutically effective amount of an N-desethyloxybutynin compound combined with a pharmaceutically acceptable carrier, wherein the dosage form provides a greater potency for treating sialorrhea when administered to a subject than an equivalent dosage form with an equivalent amount of oxybutynin. 
     
     
         12 . A dosage form according to  claim 11 , wherein the N-desethyloxybutynin comprises (R)—N-desethyloxybutynin or a pharmaceutically acceptable salt thereof or (S)—N-desethyloxybutynin or a pharmaceutically acceptable salt thereof, or a combination thereof. 
     
     
         13 . A dosage form according to  claim 11 , wherein the N-desethyloxybutynin is in a form capable of being administered via oral, buccal, transdermal, inhalation, implantation, vaginal or rectal routes of administration. 
     
     
         14 . A dosage form according to  claim 11 , wherein the N-desethyloxybutynin is formulated for oral administration. 
     
     
         15 . A dosage form according to  claim 14 , wherein the oral administration is either transmucosal administration through the oral cavity or enteral administration, or a combination thereof. 
     
     
         16 . A dosage form according to  claim 14 , wherein the dosage form is formulated for immediate release of N-desethyloxybutynin. 
     
     
         17 . A dosage form according to  claim 14 , wherein the dosage form is formulated for controlled release of N-desethyloxybutynin. 
     
     
         18 . A dosage form according to  claim 11 , wherein the N-desethyloxybutynin is formulated for transdermal administration. 
     
     
         19 . A dosage form according to  claim 11 , wherein the N-desethyloxybutynin is formulated as a tablet, capsule, or liquid for oral administration. 
     
     
         20 . A dosage form according to  claim 19 , wherein the N-desethyloxybutynin is an oral tablet.

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