Nasal compositions stimulating ciliary activity

Abstract

Nasal compositions, comprising an aqueous solution containing caffeine and/or theobromine in a total concentration of up to about 0.5% (w/v) and an aqueous carrier having a pH of about 6-8 and comprising physiologically acceptable salts of sodium, potassium and calcium. The nasal composition when used as a nasal spray or as nasal drops or irrigation fluid is able to clean the nasal passages and to stimulate nasal mucociliary clearance and, in contrast to nasal decongestants, may be used on a daily-basis for a period longer than 5 days.

1 . An aqueous nasal composition comprising caffeine and/or theobromine in a total concentration of at least 0.001% and up to about 0.5% (w/v) and an aqueous carrier having a pH of about 6-8 and comprising physiologically acceptable salts of sodium, potassium and calcium. 
     
     
         2 . A composition as claimed in  claim 1 , comprising about 80-200 mM Na+. 
     
     
         3 . A composition as claimed in  claim 1 , comprising about 1-10 mM K+. 
     
     
         4 . A composition as claimed in  claim 1 , comprising about 0.5-7 mM Ca2+ ions. 
     
     
         5 . A composition as claimed in  claim 1 , comprising an aqueous infusion, extract, tea, and/or other galenical preparation prepared from one or more plant products, containing caffeine and/or theobromine. 
     
     
         6 . A composition as claimed in  claim 1 , which comprises physiologically acceptable chloride salts. 
     
     
         7 . An aqueous nasal composition according to  claim 1 , wherein the composition is sterile. 
     
     
         8 . An aqueous nasal composition according to  claim 1 , further comprising a buffer and/or a saccharide. 
     
     
         9 .- 14 . (canceled) 
     
     
         15 . A unit dose device or container containing a composition as claimed in  claim 1 . 
     
     
         16 . A method for the treatment of a human subject in need of nasal cleansing, or suffering from nasal congestion or common cold, or for the prevention of nasal infectious diseases or nasal allergic diseases, comprising administering to the nose of said human subject a composition according to  claim 1 . 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 16 , wherein the composition is administered as needed daily, and over a period of more than about 5 days. 
     
     
         19 . The method of  claim 16 , wherein the composition is administered about every 2-6 hours as needed. 
     
     
         20 . The method of  claim 16 , wherein the composition is delivered by a nasal spray configured to administer about 25-150 μl of said composition per activation. 
     
     
         21 . The method of  claim 16 , wherein the composition is delivered as doses consisting of one or more drops of said composition by a unit dose device or container for nasal administration, in a total volume of about 25-150 μl per administration. 
     
     
         22 . The method of  claim 16 , wherein the composition is delivered as a nasal wash or irrigation in a volume of about 250-2000 μl, or more, per administration.