Long-term stable pharmaceutical preparation containing the active ingredient glycerol 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 . A pharmaceutical preparation consisting essentially of: glycerol trinitrate in a quantity between about 0.2% and about 5% w/w; a triglyceride and an alcohol, wherein the triglyceride and the alcohol are mixed in a ratio of about 10:90 to about 90:10; a buffer selected from the group consisting of: pharmaceutically acceptable salts of lactic acid, phosphoric acid, and stearic acid, in a quantity less than about 0.5% w/w; water in a quantity less than about 5.0% w/w; a medium-chain partial glyceride, and a flavoring agent; wherein the pharmaceutical preparation is in the form of a spray solution. 
   
   
       2 . The preparation according to  claim 1 , wherein the buffer is sodium lactate, disodium monohydrogen phosphate, sodium phosphate, or calcium stearate. 
   
   
       3 . The preparation according to  claim 1 , wherein the preparation contains water in a quantity less than about 0.5% w/w. 
   
   
       4 . The preparation of  claim 1 , wherein the triglyceride is a medium-chain triglyceride, a medium-chain partial glyceride, a triglyceride of plant or semi-synthetic origin, a miglyol-type saturated C 8  to C 12  fatty acid triglyceride, Miglyol 810, Miglyol 812, or a combination of any two or more of the foregoing. 
   
   
       5 . The preparation of  claim 1 , wherein the alcohol is a physiologically compatible alcohol, a polyalcohol, propylene glycol, ethanol, absolute ethanol, or a combination of any two or more of the foregoing. 
   
   
       6 . The preparation of  claim 1 , wherein the glyceryl trinitrate is provided in an effective dose when delivered using a pump spray. 
   
   
       7 . The preparation of  claim 1 , wherein the quantity of glycerol trinitrate is effective to treat angina pectoris. 
   
   
       8 . The preparation of  claim 1 , wherein the triglyceride is in a quantity between about 10% and about 80% w/w and the alcohol is in a quantity between about 10% and about 80% w/w.