Stabilized compressed nitroglycerin tablets.
A stabilized compressed nitroglycerin tablet, containing microocrystalline cellulose NF and providone NF as stabilizing agents, was formulated. Bioavailability and physical tests were conducted on the compressed tablet and two leading brands of molded tablets. There was no difference in the mean pulse rate between a molded tablet formulation and the compressed tablet in a crossover study using 10 human volunteers and three tablet strengths, 0.3, 0.4, and 0.6 mg. The compressed tablet was most uniform when tested according to the USP method for weight variation and content uniformity. Various tests for nitroglycerin loss due to volatility, i.e., open dish test, thermogravimetric analysis, and simulated in-use test, all indicated that the stabilized compressed tablet was substantially more stable than partially stabilized or unstabilized molded tablets.
D000328:Adult; D000818:Animals; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D004285:Dogs; D004355:Drug Stability; D005260:Female; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000032:analysis / Q000494:pharmacology; D012995:Solubility; D013607:Tablets; D013997:Time Factors; D014835:Volatilization
D013607:Tablets; D005996:Nitroglycerin