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

Abstract

Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in an extended-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients formulated for extended-release. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of a pharmaceutical composition comprising an analgesic agent formulated for extended-release.

1 - 28 . (canceled) 
     
     
         29 . A pharmaceutical composition, comprising:
 a first component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and   a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents,   wherein the immediate-release subcomponent and the extended-release subcomponent in the first component each comprises an active ingredient comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and   wherein the immediate-release subcomponent and the extended-release subcomponent in the second component each comprises an active ingredient comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen.   
     
     
         30 . The pharmaceutical composition of  claim 29 , wherein the second component is coated with an enteric coating. 
     
     
         31 . The pharmaceutical composition of  claim 29 , wherein the second component is formulated to release the subcomponents after a lag time of 2-4 hours following oral administration. 
     
     
         32 . The pharmaceutical composition of  claim 29 , wherein the extended-release subcomponent in the first component is formulated to release its active ingredient over a time interval of about 2-10 hours. 
     
     
         33 . The pharmaceutical composition of  claim 32 , wherein the extended-release subcomponent in the second component is formulated to release its active ingredient over a time interval of about 2-10 hours. 
     
     
         34 . The pharmaceutical composition of  claim 29 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the first component further comprises an antimuscarinic agent. 
     
     
         35 . The pharmaceutical composition of  claim 34 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the second component further comprises an antimuscarinic agent. 
     
     
         36 . The pharmaceutical composition of  claim 29 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the first component further comprises an antidiuretic agent. 
     
     
         37 . The pharmaceutical composition of  claim 36 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the second component further comprises an antidiuretic agent. 
     
     
         38 . The pharmaceutical composition of  claim 29 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the first component further comprises an spasmolytic. 
     
     
         39 . The pharmaceutical composition of  claim 38 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent in the second component further comprises an spasmolytic. 
     
     
         40 . The pharmaceutical composition of  claim 29 , wherein the immediate-release subcomponent and the extended-release subcomponent in the first component each comprises acetaminophen in an amount of 5-2000 mg. 
     
     
         41 . The pharmaceutical composition of  claim 40 , wherein the immediate-release subcomponent and the extended-release subcomponent in the second component each comprises acetaminophen in an amount of 5-2000 mg. 
     
     
         42 . The pharmaceutical composition of  claim 29 , wherein the active ingredient in the immediate-release subcomponent of the first component and the active ingredient in the immediate-release subcomponent of the second component comprise different analgesic agents. 
     
     
         43 . A pharmaceutical composition, comprising:
 a first component comprising an immediate-release subcomponent, wherein the immediate-release subcomponent comprises an active ingredient comprising acetaminophen in an amount of 5-2000 mg, wherein the first component is formulated to release its subcomponent immediately after oral administration; and   a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated to release its subcomponent after gastric emptying,   wherein the immediate-release subcomponent and the extended-release subcomponent in the second component each comprises an active ingredient comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen.   
     
     
         44 . The pharmaceutical composition of  claim 43 , wherein the second component is formulated to release the subcomponents after a lag time of 2-4 hours following oral administration. 
     
     
         45 . The pharmaceutical composition of  claim 43 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent of the second component comprises acetaminophen. 
     
     
         46 . The pharmaceutical composition of  claim 43 , wherein the first component further comprises an extended-release subcomponent, wherein the extended-release subcomponent comprises an active ingredient comprising an analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen. 
     
     
         47 . The pharmaceutical composition of  claim 46 , wherein active ingredient in the immediate-release subcomponent and the extended-release subcomponent of the second component further comprises an agent selected from the group consisting of antimuscarinic agents, antidiuretic agents and spasmolytics. 
     
     
         48 . The pharmaceutical composition of  claim 47 , wherein the active ingredient in the immediate-release subcomponent and the extended-release subcomponent of the first component further comprises an agent selected from the group consisting of antimuscarinic agents, antidiuretic agents and spasmolytics. 
     
     
         49 . A pharmaceutical composition for reducing the frequency of urination, comprising:
 a first component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the first component is formulated to release the subcomponents immediately after administration; and   a second component comprising an immediate-release subcomponent and an extended-release subcomponent, wherein the second component is formulated for a delayed-release of the subcomponents,   wherein the immediate-release subcomponent and the extended-release subcomponent in the first component each comprises an active ingredient comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and   wherein the immediate-release subcomponent and the extended-release subcomponent in the second component each comprises an active ingredient comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen,   wherein the pharmaceutical composition reduces the frequency of urination in patients in need thereof.