Sublingual nitroglycerin. I. Comparative evaluation of the physical stability of commercially available tablets.

The physical stability of one type of stabilized molded and three types of compressed nitroglycerin tablets was studied. The evaporation rate of nitroglycerin was controlled by its vapour pressure and by the matrix effect of the dosage forms. The four products showed different vapour pressures and matrix effects. In time nitroglycerin escapes from the outmost layers of the tablets; the dosage form in which the drug showed the lowest vapour pressure (the stabilized molded tablet) was found to be the most stable one. However, from the time when the drug had escaped from the outmost layers of the dosage form, the matrix effect became dominant. When nitroglycerin tablets were stored in tightly closed containers at room temperature potency loss was minimal. Even when the bottles were opened regularly this did not result in a significant loss of the drug. Measures are suggested to minimize drug evaporation.