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 . Pharmaceutical preparation comprising the active substance glyceryl trinitrate, characterised in that the preparation further contains at least one buffer substance. 
     
     
         2 . Preparation according to  claim 1 , characterised in that the buffer substance is able to absorb protons at a pH below 7. 
     
     
         3 . Preparation according to  claim 1 , characterised in that the buffer substance is chosen from the group consisting of physiologically compatible salts of organic acids, physiologically compatible salts of polymeric anions and/or physiologically compatible salts of inorganic acids. 
     
     
         4 . Preparation according to  claim 1 , characterised in that the buffer substance is chosen 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. 
     
     
         5 . Preparation according to  claim 1 , characterised in that the buffer substance is chosen 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. 
     
     
         6 . Preparation according to  claim 1 , characterised in that the content of buffer substance is less than 0.5% by weight with reference to the preparation. 
     
     
         7 . Preparation according to  claim 1 , characterised in that the buffer substance sodium lactate in contained in a quantity of 0.001-0.5% by weight with reference to the preparation. 
     
     
         8 . Preparation according to  claim 1 , characterised in that the preparation comprises less than 0.5% by weight water. 
     
     
         9 . Preparation according to  claim 1 , characterised in that the preparation contains between 10 and 80% by weight ethanol and between 10 and 80% by weight triglycerides, in each case with reference to the preparation. 
     
     
         10 . Preparation according to  claim 1 , characterised in that the preparation contains between 0.2 and 5% by weight glyceryl trinitrate with reference to the preparation. 
     
     
         11 . Container comprising a preparation according to  claim 1 , characterised in that it consists of glass or plastic material. 
     
     
         12 . Container comprising a preparation according to  claim 1 , wherein the buffer substance is applied onto the parts of the container which are in contact with the preparation. 
     
     
         13 . Container according to  claim 12  in the form of a bottle, wherein the buffer substance is applied to the inside surface of the bottle. 
     
     
         14 . Container according to  claim 13  in the form of a spray bottle, whereby the buffer substance is applied onto the parts of the spray pump being in contact with the preparation. 
     
     
         15 . Container according to  claim 1 , characterised in that the container consists of a plastic material.