Composition for reducing frequency of urination, method of making and use thereof

Abstract

Pharmaceutical compositions for reducing frequency of urination are disclosed. The pharmaceutical compositions comprise one or more prostaglandin pathway inhibitors and a pharmaceutically acceptable carrier. Also disclosed are methods of making and using the pharmaceutical compositions.

1 .- 13 . (canceled) 
     
     
         14 . A method for manufacturing a pharmaceutical composition for reducing the frequency of urination, comprising:
 forming a core structure comprising a first active ingredient formulated for immediate release and a second active ingredient formulated for extended release;   coating the core structure with a delayed release coating to form a coated core structure;   mixing the coated core structure with a third active ingredient formulated for immediate release and a fourth active ingredient formulated for extended release to form a final mixture; and   preparing a dosage form with the final mixture,   wherein at least one of the first, second, third and fourth active ingredients comprises a prostaglandin pathway inhibitor.   
     
     
         15 . The method of  claim 14 , wherein at least one of the first, second, third and fourth active ingredients comprises an analgesic agent. 
     
     
         16 . The method of  claim 15 , wherein at least one of the first, second, third and fourth active ingredients comprises (1) prostaglandin pathway inhibitor and (2) an analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin, nabumetone, and acetaminophen. 
     
     
         17 . The method of  claim 15 , wherein the prostaglandin pathway inhibitor is an inhibitor of prostaglandin activity and wherein the analgesic agent is acetaminophen. 
     
     
         18 . The method of  claim 15 , wherein the prostaglandin pathway inhibitor is an inhibitor of prostaglandin synthesis and wherein the analgesic agent is acetaminophen. 
     
     
         19 . The method of  claim 15 , wherein the prostaglandin pathway inhibitor is an inhibitor of prostaglandin transporter activity or prostaglandin transporter expression and wherein the analgesic agent is acetaminophen. 
     
     
         20 . The method of  claim 15 , wherein the prostaglandin pathway inhibitor is an inhibitor of prostaglandin receptor activity or prostaglandin receptor expression and wherein the analgesic agent is acetaminophen. 
     
     
         21 . The method of  claim 15 , wherein at least one of the first, second, third and fourth active ingredients comprises an agent selected from the group consisting antimuscarinic agents, antidiuretic agents and spasmolytics. 
     
     
         22 . A pharmaceutical composition produced by the method of  claim 14 . 
     
     
         23 .- 48 . (canceled) 
     
     
         49 . A pharmaceutical composition, comprising:
 an immediate-release component comprising acetaminophen and an NSAID, each in an amount of 5-2000 mg; and   an extended-release component comprising acetaminophen and an NSAID, each in an amount of 5-2000 mg,   wherein the immediate-release component, or the extended-release component, or both, further comprise a prostaglandin pathway inhibitor.   
     
     
         50 . The pharmaceutical composition of  claim 49 , wherein the extended-release component is further coated with a delayed-release coating. 
     
     
         51 . The method of  claim 14 , wherein the delayed release coating is an enteric coating. 
     
     
         52 . The method of  claim 51 , wherein the enteric coating comprises a pH-dependent polymer. 
     
     
         53 . The method of  claim 14 , wherein the delayed release coating comprises a swelling layer covered by an outer semi-permeable polymer layer. 
     
     
         54 . The method of  claim 14 , wherein the second active ingredient, or the fourth active ingredient or both comprise an active core comprising an extended-release coating or a polymeric matrix effecting diffusion controlled release. 
     
     
         55 . The method of  claim 14 , wherein at least one of the first, second, third and fourth active ingredients comprises acetaminophen in an amount of 5-2000 mg. 
     
     
         56 . The method of  claim 14 , wherein each of the first, second, third and fourth active ingredients comprises acetaminophen in an amount of 5-2000 mg.