Pharmaceutical formulation for bedwetting and method of use thereof

Abstract

Methods and compositions for treating bedwetting are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising one or more analgesic agents.

What is claimed is: 
     
         1 . A method for treating bedwetting in a subject, comprising:
 administering to a subject in need thereof a pharmaceutical composition comprising:   an active ingredient comprising one or more analgesic agents in an amount of 1-1000 mg per agent, wherein said one or more analgesic agents are selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen.   
     
     
         2 . The method of  claim 1 , wherein said pharmaceutical composition is formulated for extended-release such that said active ingredient is released continuously over a period of 2-12 hours. 
     
     
         3 . The method of  claim 2 , wherein said pharmaceutical composition is further coated with an enteric coating. 
     
     
         4 . The method of  claim 1 , wherein said pharmaceutical composition is formulated for extended release, characterized by a two-phase release profile in which 20-60% of said active ingredient is released within two hours of administration and remainder of said active ingredient is released continuously over a period of 2-12 hours. 
     
     
         5 . The method of  claim 4 , wherein said pharmaceutical composition is coated with an enteric coating. 
     
     
         6 . The method of  claim 1 , wherein said pharmaceutical composition is formulated for delayed-release. 
     
     
         7 . The method of  claim 1 , wherein said one or more analgesic agents consist of acetaminophen. 
     
     
         8 . The method of  claim 7 , wherein said one or more analgesic agents consist of acetaminophen in an amount of 3-300 mg. 
     
     
         9 . The method of  claim 1 , wherein said one or more analgesic agents consist of acetaminophen and one other analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, and nabumetone. 
     
     
         10 . The method of  claim 1 , wherein said active ingredient further comprises an antimuscarinic agent. 
     
     
         11 . The method of  claim 1 , wherein said active ingredient further comprises an antidiuretic. 
     
     
         12 . The method of  claim 11 , wherein said antidiuretic is desmopressin. 
     
     
         13 . The method of  claim 1 , wherein said active ingredient further comprises a spasmolytic. 
     
     
         14 . The method of  claim 1 , wherein said active ingredient further comprises an inhibitor of phosphodiesterase type 5 (PDE 5 inhibitor). 
     
     
         15 . The method of  claim 14 , wherein said PDE 5 inhibitor is tadalafil. 
     
     
         16 . The method of  claim 1 , wherein said active ingredient further comprises two additional agents selected from the group consisting of an antimuscarinic agent, an antidiuretic, a spasmolytic and a PDE 5 inhibitor. 
     
     
         17 . The method of  claim 1 , wherein said pharmaceutical composition is formulated for immediate-release. 
     
     
         18 . A method for treating bedwetting in a subject, comprising:
 administering to a subject in need thereof a pharmaceutical composition comprising:   a first active ingredient comprising one or more agents selected from the group consisting analgesic agents, antimuscarinic agents, antidiuretics, spasmolytics and PDE 5 inhibitors; and   a second active ingredient comprising one or more agents selected from the group consisting of analgesic agents, antimuscarinic agents, antidiuretics, spasmolytics and PDE 5 inhibitors,   wherein said first active ingredient is formulated for immediate release and wherein said second active ingredient is formulated for extended release.   
     
     
         19 . The method of  claim 18 , wherein said pharmaceutical composition is further coated with an enteric coating. 
     
     
         20 . The method of  claim 18 , wherein said first active ingredient comprises an analgesic. 
     
     
         21 . The method of  claim 20 , wherein said first active ingredient further comprises an antimuscarinic agent. 
     
     
         22 . The method of  claim 20 , wherein said active ingredient further comprises an antidiuretic. 
     
     
         23 . The method of  claim 22 , wherein said antidiuretic is desmopressin. 
     
     
         24 . The method of  claim 18 , wherein said first active ingredient further comprises a spasmolytic. 
     
     
         25 . The method of  claim 18 , wherein said first active ingredient further comprises a PDE 5 inhibitor. 
     
     
         26 . The method of  claim 25 , wherein said PDE 5 inhibitor is tadalafil. 
     
     
         27 . A pharmaceutical composition, comprising:
 one or more analgesic agents;   desmopressin; and   a pharmaceutically acceptable carrier.   
     
     
         28 . The pharmaceutical composition of  claim 27 , wherein said one or more analgesic agents are formulated for extended release and wherein said desmopressin is formulated for immediate release. 
     
     
         29 . The pharmaceutical composition of  claim 27 , wherein said one or more analgesic agents and said desmopressin are formulated for extended release over a period of 2-12 hours. 
     
     
         30 . The pharmaceutical composition of  claim 27 , wherein said desmopressin and 20-60% of each of said one or more analgesic agents are formulated for immediate release, and wherein remainder of each of said one or more analgesic agents is formulated for extended release. 
     
     
         31 . The pharmaceutical composition of  claim 27 , wherein said pharmaceutical composition is coated with an enteric coating.