US2014154320A1PendingUtilityA1

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

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Assignee: WELLESLEY PHARMACEUTICALS LLCPriority: Jul 8, 2010Filed: Feb 4, 2014Published: Jun 5, 2014
Est. expiryJul 8, 2030(~4 yrs left)· nominal 20-yr term from priority
Inventors:David A. Dill
A61P 43/00A61K 31/167A61K 31/12A61K 31/616A61K 31/216A61K 45/06A61K 31/60A61K 31/4725A61K 31/4025A61K 31/46A61P 13/00A61P 13/06A61K 31/405A61K 9/0002A61K 31/19A61P 13/10A61P 13/02A61K 31/192A61K 9/48A61K 2121/00A61P 7/12A61K 2300/00A61K 9/28
56
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 28 . (canceled) 
     
     
         29 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated for extended-release,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg.   
     
     
         30 . The method of  claim 29 , wherein said acetaminophen is administered at a daily dose of 100 mg to 500 mg. 
     
     
         31 . The method of  claim 29 , wherein said acetaminophen is administered at a daily dose of 500 mg to 2000 mg. 
     
     
         32 . The method of  claim 29 , wherein said acetaminophen is administered at a daily dose of 50 mg to 1600 mg. 
     
     
         33 . The method of  claim 29 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents. 
     
     
         34 . The method of  claim 29 , wherein said pharmaceutical composition further comprises one or more antidiuretics. 
     
     
         35 . The method of  claim 29 , wherein said pharmaceutical composition further comprises one or more spasmolytics. 
     
     
         36 . The method of  claim 29 , wherein acetaminophen is embedded in a matrix of insoluble substance(s). 
     
     
         37 . The method of  claim 29 , wherein said pharmaceutical composition comprises a polymer controlling release by dissolution controlled release. 
     
     
         38 . The method of  claim 29 , wherein said pharmaceutical composition comprises a water soluble or water-swellable matrix-forming polymer. 
     
     
         39 . The method of  claim 29 , wherein said pharmaceutical composition further comprises an enteric coating. 
     
     
         40 . The method of  claim 29 , wherein said pharmaceutical composition is administered orally. 
     
     
         41 . The method of  claim 29 , wherein said pharmaceutical composition is formulated for the oral administration. 
     
     
         42 . The method of  claim 29 , wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. 
     
     
         43 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated for immediate release,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg.   
     
     
         44 . The method of  claim 43 , wherein said acetaminophen is administered at a daily dose of 100 mg to 1500 mg. 
     
     
         45 . The method of  claim 43 , wherein said acetaminophen is administered at a daily dose of 200 mg to 1000 mg. 
     
     
         46 . The method of  claim 43 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents. 
     
     
         47 . The method of  claim 43 , wherein said pharmaceutical composition further comprises one or more antidiuretics. 
     
     
         48 . The method of  claim 43 , wherein said pharmaceutical composition further comprises one or more spasmolytics. 
     
     
         49 . The method of  claim 43 , wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. 
     
     
         50 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in an extended-release formulation having an immediate-release component and an extended-release component,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg.   
     
     
         51 . The method of  claim 50 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents in said immediate-release component, or said extended-release component, or both components. 
     
     
         52 . The method of  claim 50 , wherein said pharmaceutical composition further comprises one or more antidiuretics in said immediate-release component, or said extended-release component, or both components. 
     
     
         53 . The method of  claim 50 , wherein said pharmaceutical composition further comprises one or more spasmolytics in said immediate-release component, or said extended-release component, or both components. 
     
     
         54 . The method of  claim 50 , wherein said pharmaceutical composition further comprises one or more analgesic agents in said immediate-release component, or said extended-release component, or both components,
 wherein said one or more analgesic agents are selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone.   
     
     
         55 . The method of  claim 50 , wherein said pharmaceutical composition is administered orally. 
     
     
         56 . The method of  claim 50 , wherein said pharmaceutical composition is formulated for the oral administration. 
     
     
         57 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in an extended-release formulation having an immediate-release component and an extended-release component,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg and wherein said extended release component of said pharmaceutical composition is coated with a delayed release coating.   
     
     
         58 . The method of  claim 57 , wherein said delayed release coating is enteric coating. 
     
     
         59 . The method of  claim 57 , wherein said pharmaceutical composition is administered orally. 
     
     
         60 . The method of  claim 57 , wherein said pharmaceutical composition is formulated for the oral administration. 
     
     
         61 . The method of  claim 57 , wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. 
     
     
         62 . The method of  claim 61 , wherein said analgesic agents is administered at a daily dose of 5 mg to 2000 mg and wherein said extended release component of said pharmaceutical composition is coated with a delayed release coating.

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