Novel pharmaceutical composition and its use in a method for treatment of patients with upper respiratory mucosal congestion

Abstract

The present invention relates to a pharmaceutical composition including loratadine or a pharmaceutically acceptable form thereof, and phenylephrine or a pharmaceutically acceptable form thereof, for treating upper respiratory/mucosal congestion, optionally by administering to a patient four times a day.

1 . A pharmaceutical composition including loratadine or a pharmaceutically acceptable form thereof, and phenylephrine or a pharmaceutically acceptable form thereof, for treating upper respiratory/mucosal congestion. 
   
   
       2 . A pharmaceutical composition according to  claim 1 , wherein the composition is for administering to a patient four times a day. 
   
   
       3 . A composition according to  claim 1 , wherein the pharmaceutically acceptable form of loratadine is a salt form of such substance. 
   
   
       4 . A composition according to  claim 1 , wherein the pharmaceutically acceptable form of phenylephrine is a salt form of such substance. 
   
   
       5 . A composition according to  claim 1 , which is for administration on a qid basis. 
   
   
       6 . A composition according to  claim 1 , wherein the phenylephrine is present as a hydrochloride salt. 
   
   
       7 . A composition according to  claim 1 , which is in a solid dosage form. 
   
   
       8 . A pharmaceutical composition according to  claim 1 , which is in the form of a pill, capsule or tablet. 
   
   
       9 . A pharmaceutical composition according to  claim 1 , comprising lactose, maize starch, pregelatinised starch, quinoline yellow, sodium metabisulphite, disodium EDTA, talc and magnesium stearate. 
   
   
       10 . A pharmaceutical composition according to  claim 1 , having synergistic therapeutic activity. 
   
   
       11 . A pack including a pharmaceutical composition according to  claim 1 , wherein the pack includes instructions to administer the composition to a maximum of 4 times a day. 
   
   
       12 . The use of loratadine or a pharmaceutically acceptable form thereof, and phenylephrine or a pharmaceutically acceptable form thereof, in the manufacture of a pharmaceutical composition for treating upper respiratory/mucosal congestion. 
   
   
       13 . A use according to  claim 12 , wherein the composition is for administering to a patient four times a day. 
   
   
       14 . A use according to  claim 12 , wherein the pharmaceutically acceptable form of loratadine is a salt form of such substance. 
   
   
       15 . A use according to  claim 12 , wherein the pharmaceutically acceptable form of phenylephrine is a salt form of such substance. 
   
   
       16 . A use according to  claim 12 , wherein the pharmaceutical composition is for administration on a qid basis. 
   
   
       17 . A use according to  claim 12 , wherein the phenylephrine is present in the composition as a hydrochloride salt. 
   
   
       18 . A use according to  claim 12 , wherein the composition is a solid dosage form. 
   
   
       19 . A use according to  claim 12 , wherein the composition is in the form of a pill, capsule or tablet. 
   
   
       20 . A use according to  claim 12 , wherein lactose, maize starch, pregelatinised starch, sodium metabisulphite, disodium EDTA, talc, and magnesium stearate are also used in the manufacture of the pharmaceutical composition.