Delayed-release formulations, methods of making and use thereof

Abstract

Compositions for reducing the frequency of urination and methods of manufacture of the compositions are disclosed. One method of manufacture include the steps of forming a first mixture comprising a first active ingredient comprising one or more analgesic, coating the first mixture with a first delayed-release coating to form a first component, forming a second mixture comprising a second active ingredient comprising one or more analgesic agents, coating the second mixture with a second delayed-release coating to form a second component, and combining the first component with the second component to form a third mixture.

1 - 27 . (canceled) 
     
     
         28 . A pharmaceutical composition, comprising:
 a first component comprising acetaminophen in an amount of 5-2000 mg, wherein the first component is formulated for immediate-release; and   a second component comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, wherein the second component is formulated for delayed-release with a lag time of 1-4 hours; and   a third component comprising one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, wherein the third component is formulated for delayed-release with a lag time of 4-6 hours.   
     
     
         29 . The pharmaceutical composition of  claim 28 , wherein the second component is coated with an enteric coating. 
     
     
         30 . The pharmaceutical composition of  claim 28 , wherein the first component and/or the second component and/or the third component further comprises an agent selected from the group consisting of antimuscarinic agents, antidiuretic agents and spasmolytics. 
     
     
         31 . The pharmaceutical composition of  claim 30 , wherein the second component is coated with an enteric coating. 
     
     
         32 . The pharmaceutical composition of  claim 28 , wherein the second component or the third component is coated with a water insoluble polymer (WIP) and an enteric polymer (EP) at a WIP:EP ratio of 4:1 to 1:2. 
     
     
         33 . The pharmaceutical composition of  claim 28 , wherein the third component is coated with multiple coating layers. 
     
     
         34 . The pharmaceutical composition of  claim 28 , wherein the first component further comprises ibuprofen. 
     
     
         35 . The pharmaceutical composition of  claim 28 , wherein the second component comprises acetaminophen and ibuprofen. 
     
     
         36 . The pharmaceutical composition of  claim 28 , wherein the third component comprises acetaminophen and ibuprofen. 
     
     
         37 . The pharmaceutical composition of  claim 28 , wherein both the second component and third component comprise acetaminophen and ibuprofen. 
     
     
         38 . The pharmaceutical composition of  claim 28 , wherein the first component further comprises ibuprofen and wherein both the second component and third component comprise acetaminophen and ibuprofen.