Comparative Pharmacological Evaluation of Different Sublingual Nitroglycerin Formulations

Abstract

Using a double blind, randomized cross-over design, the heart rate and systolic blood pressure of five healthy human subjects were compared following sublingual administration of three different nitroglycerin tablets and a placebo. The nitro-glycerin formulations included two commercially available tablets (one molded and one directly compressed) and an experimental tablet (directly compressed) which was developed in our laboratorq. Significant increase in heart.rate (P<0. 05) was demonstrated for two of the three nitroglycerin formulations when compared to placebo, but no difference in heart rate elevation could be observed among the three active products. Decrease in systolic blood pressure was shown to be a less consistt.nt circulatory response to sublingual nitroglycerin in this study, and no statistical significance (P > 0.05) in this parameter could be observed in the different treatments. It appeared that formulation factors such as addition of stabilizers and insoluble adjuvants to the dosage forms and change in tablet prt-paration methods did not significantly affect the pharmaculogical performance in circulatory effects of nitroglycerin.