Long-term stable pharmaceutical preparation containing the active ingredient glyceryl trinitrate

Abstract

A pharmaceutical preparation containing the active substance glyceryl trinitrate having improved storage stability in a container. The improved storage stability is achieved by the addition of a proton-absorbing substance either as part of the preparation as placed into the container or applied to the surface of the preparation's storage container before the remaining components of the preparation are placed into the container. The preparation can preferably be filled into a plastic bottle having a spray pump.

1 - 8 . (canceled) 
     
     
         9 . A solution of glyceryl trinitrate, said solution prepared in accordance with the steps of: combining glyceryl trinitrate with a triglyceride and a proton absorbing agent, thereby preparing a solution of glyceryl trinitrate wherein the formation of its degradation product, 1,2-glyceryl dinitrate, is retarded. 
     
     
         10 . The solution of  claim 9 , wherein the solution is contained in a pump spray container. 
     
     
         11 . The solution of  claim 9 , wherein the proton absorbing agent is in the form of a container coated with a proton absorbing agent or a container fabricated from a material having properties of a proton absorbing agent, wherein the container retards formation of the degradation product, 1,2-glyceryl dinitrate. 
     
     
         12 . An article of manufacture comprising a solution of glyceryl trinitrate and a triglyceride; a proton absorbing agent; and a container for containing the solution. 
     
     
         13 . The article of manufacture of  claim 12  wherein the proton absorbing agent is applied to a surface of the container which is in contact with the solution of glyceryl trinitrate. 
     
     
         14 . The article of manufacture of  claim 13 , wherein the container is a spray bottle having a spray pump and wherein the proton absorbing agent is applied to a part of the spray pump which is in contact with the solution of glyceryl trinitrate. 
     
     
         15 . The article of manufacture of  claim 13 , wherein the proton absorbing agent applied to the container is a buffer substance. 
     
     
         16 . The article of manufacture of  claim 15 , wherein the buffer substance is selected from the group consisting of: physiologically compatible salts of organic acids, physiologically compatible salts of polymeric anions, and physiologically compatible salts of inorganic acids. 
     
     
         17 . The article of manufacture of  claim 15 , wherein the buffer substance is selected from the group consisting of: sodium and calcium salts of mono- and dicarboxylic acids, sodium salts of polymeric carboxylates, sodium and calcium compounds of silicic acid or silica gel, respectively, and sodium, potassium, magnesium and calcium salts of phosphoric acid. 
     
     
         18 . The article of manufacture of  claim 15 , wherein the buffer substance is selected from the group consisting of: sodium and calcium stearate, the sodium salt of hydroxypropyl methylcellulose acetate succinate, the sodium salt of polyacrylate, polymethacrylate or carboxymethylcellulose, disodium monohydrogen phosphate, sodium phosphate and sodium lactate. 
     
     
         19 . The article of manufacture of  claim 15 , wherein the buffer substance is sodium phosphate or sodium lactate. 
     
     
         20 . The article of manufacture of  claim 15 , wherein the buffer substance is sodium lactate. 
     
     
         21 . The article of manufacture of  claim 12 , further comprising less than about 5.0% by weight water. 
     
     
         22 . The article of manufacture of  claim 12 , wherein the solution further comprises an alcohol wherein the alcohol and the triglyceride are mixed in a ratio of about 10:90 to about 90:10.