Extended-release formulation for reducing the frequency of urination and method of use thereof

Abstract

A method for reducing the frequency of urination is disclosed. The method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising one or more analgesic agents and one or more α-blockers. In one embodiment, the one or more analgesic agents are formulated for extended-release.

1 . A method for reducing the frequency of urination, comprising:
 administering to a subject in need thereof a pharmaceutical composition comprising:   acetaminophen;   ibuprofen; and   one or more additional active ingredients selected from the group consisting of α-blockers and 5α-reductase inhibitors.   
     
     
         2 . The method of  claim 1 , wherein said acetaminophen, ibuprofen and said one or more additional active ingredients are formulated for immediate release. 
     
     
         3 . The method of  claim 1 , wherein said acetaminophen, ibuprofen and said one or more additional active ingredients are formulated for delayed release. 
     
     
         4 . The method of  claim 1 , wherein said acetaminophen, ibuprofen and said one or more additional active ingredients are formulated for extended release. 
     
     
         5 . The method of  claim 4 , wherein said acetaminophen and ibuprofen are administered in an amount of 50-2000 mg per agent, and wherein said pharmaceutical composition is formulated for extended-release such that said acetaminophen, ibuprofen and said one or more additional active ingredients are released continuously over a period of 5-24 hours. 
     
     
         6 . The method of  claim 5 , wherein said one or more additional active ingredients comprise tamsulosin. 
     
     
         7 . The method of  claim 5 , wherein said one or more additional active ingredients comprise finasteride. 
     
     
         8 . The method of  claim 5 , wherein said one or more additional active ingredients comprise tamsulosin and finasteride. 
     
     
         9 . The method of  claim 4 , wherein said acetaminophen and ibuprofen are administered in an amount of 50-2000 mg per agent, and wherein said pharmaceutical composition is formulated for extended release, characterized by a two-phase release profile in which 20-60% of said acetaminophen and ibuprofen are released within two hours of administration and remainder of said acetaminophen and ibuprofen are released continuously over a period of 5-24 hours. 
     
     
         10 . The method of  claim 9 , wherein said one or more additional active ingredients comprise tamsulosin. 
     
     
         11 . The method of  claim 9 , wherein said one or more additional active ingredients comprise finasteride. 
     
     
         12 . The method of  claim 9 , wherein said one or more additional active ingredients comprise tamsulosin and finasteride. 
     
     
         13 . The method of  claim 1 , wherein said acetaminophen and ibuprofen are formulated for extended release and said one or more additional active ingredients are formulated for immediate release. 
     
     
         14 . The method of  claim 13 , wherein said acetaminophen and ibuprofen are administered in an amount of 50-2000 mg per agent, and wherein said acetaminophen and ibuprofen are formulated for extended-release such that said acetaminophen and ibuprofen are released continuously over a period of 5-24 hours. 
     
     
         15 . The method of  claim 14 , wherein said one or more additional active ingredients comprise tamsulosin. 
     
     
         16 . The method of  claim 14 , wherein said one or more additional active ingredients comprise finasteride. 
     
     
         17 . The method of  claim 14 , wherein said one or more additional active ingredients comprise tamsulosin and finasteride. 
     
     
         18 . The method of  claim 13 , wherein said acetaminophen and ibuprofen are administered in an amount of 50-2000 mg per agent, and wherein said acetaminophen and ibuprofen are formulated for extended release, characterized by a two-phase release profile in which 20-60% of said acetaminophen and ibuprofen are released within two hours of administration and remainder of said acetaminophen and ibuprofen are released continuously over a period of 5-24 hours. 
     
     
         19 . The method of  claim 18 , wherein said one or more additional active ingredients comprise tamsulosin. 
     
     
         20 . The method of  claim 18 , wherein said one or more additional active ingredients comprise finasteride. 
     
     
         21 . The method of  claim 18 , wherein said one or more additional active ingredients comprise tamsulosin and finasteride. 
     
     
         22 . The method of  claim 1 , wherein said pharmaceutical composition further comprises an antimuscarinic agent. 
     
     
         23 . The method of  claim 1 , wherein said pharmaceutical composition further comprises an antidiuretic agent. 
     
     
         24 . The method of  claim 1 , wherein said pharmaceutical composition further comprises a spasmolytic. 
     
     
         25 . The method of  claim 1 , further comprising the step of administering an effective amount of a diuretic prior to the administration of said pharmaceutical composition, wherein said diuretic is administered 7 or 8 hours prior to bedtime. 
     
     
         26 . The method of  claim 1 , wherein said subject is a mammal. 
     
     
         27 . A pharmaceutical composition for reducing frequency of urination, comprising:
 acetaminophen;   one or more α-blockers, and   a pharmaceutically acceptable carrier'   wherein said one or more analgesic agents are formulated for extended release and wherein said one or more α-blockers are formulated for immediate release.   
     
     
         28 . The pharmaceutical composition of  claim 27 , comprising acetaminophen in an amount of 50-2000 mg, and wherein said acetaminophen formulated for extended-release such that said acetaminophen is released continuously over a period of 5-24 hours. 
     
     
         29 . The pharmaceutical composition of  claim 28 , wherein said one or more α-blockers comprise tamsulosin. 
     
     
         30 . The pharmaceutical composition of  claim 27 , wherein said pharmaceutical composition is formulated for extended release, characterized by a two-phase release profile in which 20-60% of said acetaminophen is released within two hours of administration and remainder of said acetaminophen is released continuously over a period of 5-24 hours. 
     
     
         31 . The pharmaceutical composition of  claim 30 , wherein said one or more α-blockers comprise tamsulosin. 
     
     
         32 . A pharmaceutical composition for reducing frequency of urination, comprising:
 acetaminophen;   one or more 5α-reductase inhibitors, and   a pharmaceutically acceptable carrier   wherein said acetaminophen is formulated for extended release and wherein said one or more 5α-reductase inhibitors are formulated for immediate release.   
     
     
         33 . The pharmaceutical composition of  claim 32 , comprising acetaminopen in an amount of 50-2000 mg, and wherein said acetaminophen is formulated for extended-release such that said acetaminophen is released continuously over a period of 5-24 hours. 
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein said one or more 5α-reductase inhibitors comprise finasteride. 
     
     
         35 . The pharmaceutical composition of  claim 32 , comprising acetaminopen in an amount of 50-2000 mg, and wherein said pharmaceutical composition is formulated for extended release, characterized by a two-phase release profile in which 20-60% of said acetaminophen is released within two hours of administration and remainder of said acetaminophen is released continuously over a period of 5-24 hours. 
     
     
         36 . The pharmaceutical composition of  claim 35 , wherein said one or more 5α-reductase inhibitors comprise finasteride.