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 - 18 . (canceled) 
   
   
       19 . A nasal spray for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia, the nasal spray comprising 0.1 μg to about 2 μg desmopressin, the nasal spray being formulated to establish in the bloodstream of the patient no more than about 2 ng/kg of desmopressin, being effective to produce an antidiuretic effect in the patient lasting for no more than about 6 hours, and being effective to produce a plasma/serum desmopressin concentration up to a maximum of about 10.0 picograms desmopressin per ml plasma/serum. 
   
   
       20 . The nasal spray of  claim 19  wherein the nasal spray is effective to establish in an adult an antidiuretic effect lasting for a maximum of between about 4 and about 6 hours. 
   
   
       21 . The nasal spray of  claim 19  which produces a plasma/serum desmopressin concentration within the range from about 0.5 picograms desmopressin per ml plasma/serum to a maximum of about 5.0 picograms desmopressin per ml plasma/serum. 
   
   
       22 . The nasal spray of  claim 19  formulated to establish in the bloodstream of the patient no more than about 1 ng/kg of desmopressin. 
   
   
       23 . The nasal spray of  claim 19  wherein the nasal spray is formulated to establish in the patient a urine osmolality ranging above about 300 mOsm/kg for less than about 5 hours after administration. 
   
   
       24 . The nasal spray of  claim 19  effective to produce an antidiuretic effect in the patient lasting no more than about 4 hours. 
   
   
       25 . An article of manufacture for inducing voiding postponement in a patient while reducing the risk that the patient develops hyponatremia comprising
 a dispenser which delivers a pharmaceutical composition comprising 0.1 μg to about 2 μg desmopressin as a spray for intranasal administration, the composition being formulated to establish in the bloodstream of the patient no more than about 2 ng/kg of desmopressin, being effective to produce an antidiuretic effect in the patient lasting for no more than about 6 hours, and being effective to produce a plasma/serum desmopressin concentration up to a maximum of about 10.0 picograms desmopressin per ml plasma/serum.   
   
   
       26 . The article of  claim 25  wherein the dispenser which delivers a pharmaceutical composition is effective to establish in an adult an antidiuretic effect lasting for a maximum of between about 4 and about 6 hours. 
   
   
       27 . The article of  claim 25  which produces a plasma/serum desmopressin concentration within the range from about 0.5 picograms desmopressin per ml plasma/serum to a maximum of about 5.0 picograms desmopressin per ml plasma/serum. 
   
   
       28 . The article of  claim 25  formulated to establish in the bloodstream of the patient no more than about 1 ng/kg of desmopressin. 
   
   
       29 . The article of  claim 25  wherein the composition is formulated to establish in the patient a urine osmolality ranging above about 300 mOsm/kg for less than about 5 hours after administration. 
   
   
       30 . The article of  claim 25  effective to produce an antidiuretic effect in the patient lasting no more than about 4 hours. 
   
   
       31 . The article of  claim 25  further comprising packaging material comprising written instructions for use of said dispenser by adults. 
   
   
       32 . The article of  claim 25  further comprising packaging material comprising written instructions advising a patient that fluid intake should be restricted after administration. 
   
   
       33 . The article of  claim 25  further comprising packaging material comprising written instructions advising a patient that the composition is for use for inducing voiding postponement or for treating a condition selected from the group consisting of hemophilia, Von Willebrand's Disease, incontinence, primary nocturnal enuresis (PNE), nocturia, and central diabetes insipidus. 
   
   
       34 . The article of  claim 25  further comprising packaging material comprising written instructions advising the patient that the composition is for use for treating nocturia, primary nocturnal enuresis (PNE), or incontinence.