Pharmaceutical Compositions Including Low Dosages of Desmopressin

Abstract

The present invention is directed to a pharmaceutical composition comprising 0.5 ng to 20 μg desmopressin and a pharmaceutically acceptable carrier. The present invention is also directed to a pharmaceutical composition comprising desmopressin and a pharmaceutically acceptable carrier, wherein the pharmaceutical composition is effective to establish a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL plasma/serum. Articles of manufacture and methods of using the above invention are also disclosed.

1 . A pharmaceutical composition, comprising 0.5 ng to 20 μg desmopressin and a pharmaceutically acceptable carrier. 
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition comprises from about 0.5 ng to about 2000 ng desmopressin. 
     
     
         3 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition comprises from about 0.05 μg to about 10 μg desmopressin. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition comprises from about 0.1 μg to about 20 μg desmopressin. 
     
     
         5 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition is adapted for intravenous, subcutaneous, transmucosal, transdermal, or intradermal delivery. 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein said pharmaceutical composition is in the form of an orodispersible solid. 
     
     
         7 . The pharmaceutical composition of  claim 1 , further comprising an open matrix network, said open matrix network comprising a water-soluble or water-dispersible carrier material that is inert towards desmopressin. 
     
     
         8 . A pharmaceutical composition, comprising desmopressin and a pharmaceutically acceptable carrier, wherein said pharmaceutical composition is effective to establish a steady plasma/serum desmopressin concentration in the range of from about 0.1 picograms desmopressin per mL plasma/serum to about 10.0 picogram desmopressin per mL plasma/serum. 
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein said steady plasma/serum desmopressin concentration is in the range of from about 0.5 picograms desmopressin per mL plasma/serum to about 5.0 picogram desmopressin per mL plasma/serum. 
     
     
         10 . The pharmaceutical composition of  claim 8 , wherein said pharmaceutical composition comprises from about 0.5 ng to about 2000 ng desmopressin. 
     
     
         11 . The pharmaceutical composition of  claim 8 , wherein said pharmaceutical composition comprises from about 0.05 μg to about 10 μg desmopressin. 
     
     
         12 . The pharmaceutical composition of  claim 8 , wherein said pharmaceutical composition comprises from about 0.1 μg to about 20 μg desmopressin. 
     
     
         13 . The pharmaceutical composition of  claim 8 , wherein said pharmaceutical composition is adapted for intravenous, subcutaneous, transmucosal, transdermal, or intradermal delivery. 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . A method inducing an antidiuretic effect in a patient, comprising the step of administering to a patient a daily dose of a therapeutically effective amount of a pharmaceutical composition comprising 0.5 ng to 20 μg desmopressin and a pharmaceutically acceptable carrier. 
     
     
         18 . The method of  claim 17 , wherein said patient is suffering from a disease selected from the group consisting of Von Willebrand's Disease, incontinence, primary nocturnal enuresis (PNE), nocturia, or central diabetes insipidus.