Bronchodilator expectorant composition containing theophylline and a guaiacol

Abstract

.Iadd.Palatable liquid pharmaceutical compositions containing theophylline and guaiacol or other water soluble form thereof such as glyceryl guaiacolate. The latter have a solubilizing effect on theophylline making possible concentrations of theophylline in solution in excess of the saturated solution value in the absence of said solubilizing agents. .Iaddend.

What is claimed is: 
     
       1. A pharmaceutical composition comprised of at least about 40% by volume of water having dissolved therein at room temperature more than 0.83 g. of theophylline per 100 ml. of water contained therein, and a solubilizing agent selected from the group consisting of guaiacol and pharmaceutically acceptable water soluble forms thereof in amount sufficient to maintain said theophylline in solution .[...]. .Iadd., wherein a greater amount of theophylline is dissolved at room temperature than the amount thereof which is soluble in the composition in the absence of said solubilizing agent, and wherein the greater amount of theophylline dissolved is made possible by the solubilizing agent. .Iaddend. 
     
     
       2. The composition of claim 1 containing up to 4.37 g. of theophylline per 100 ml. of water contained therein. 
     
     
       3. The composition of claim 1 wherein said solubilizing agent is glyceryl guaiacolate. 
     
     
       4. The composition of claim 1 containing glyceryl guaiacolate as said solubilizing agent in an amount of from 0.75 to 7.64 g. per 100 ml. of water contained therein. 
     
     
       5. The composition of claim 1 wherein said solubilizing agent is guaiacol. 
     
     
       6. The composition of claim 1 containing guaiacol as said solubilizing agent in an amount of from 0.47 to 4.05 g. per 100 ml. of water contained therein. 
     
     
       7. The composition of claim 1 containing up to 20% by volume of ethanol. 
     
     
       8. The composition of claim 1 containing sucrose as supplementary solubilizing and sweetening agent. 
     
     
       9. A pharmaceutical composition comprised of at least about 40% by volume of water having dissolved therein more than 0.83 and up to 4.37 g. of theophylline and from 0.75 to 7.64 g. of glyceryl guaiacolate per 100 ml. of water contained therein .[...]. .Iadd., wherein a greater amount of theophylline is dissolved at room temperature than the amount thereof which is soluble in the composition in the absence of said glyceryl guaiacolate, and wherein the greater amount of theophylline dissolved is made possible by the glyceryl guaiacolate. .Iaddend. 
     
     
       10. A pharmaecutical composition comprised of at least about 40% by volume of water having dissolved therein more than 0.83 and up to 3.18 g. of theophylline and from 0.75 to 4.23 g. of glyceryl guaiacolate per 100 ml. of water contained therein .[...]. .Iadd., wherein a greater amount of theophylline is dissolved at room temperature than the amount thereof which is soluble in the composition in the absence of glyceryl guaiacolate, and wherein the greater amount of theophylline dissolved is made possible by the glyceryl guaiacolate. .Iaddend. 
     
     
       11. The composition of claim 10 containing 50 mg. of theophylline, 30 mg. of glyceryl guaiacolate, 2.4 ml. of water, 0.79 ml. of ethanol U.S.P., 2.5 g. of sucrose, and sufficient flavoring agents and preservatives to provide a pharmaceutically elegant oral dosage form. 
     
     
       12. A liquid theophylline composition comprising in each 5 ml. dosage unit thereof at least 2.0 ml. of water and from 16.6 to 175 mg. of theophylline, and from 7.5 to 350 mg. of glyceryl guaiacolate, and sufficent additional pharmaceutically acceptable ingredients to provide a pharmaceutically elegant oral dosage form.[...]..Iadd., wherein a greater amount of theophylline is dissolved at room temperature than the amount thereof which is soluble in the composition in the absence of glyceryl guaiacolate, and wherein the greater amount of theophylline dissolved is made possible by the glyceryl guaiacolate..Iaddend.