Controlled-release isosorbide dinitrate pellets. Part II: In vivo studies.

Isosorbide dinitrate (ISDN) capsules containing 20.0 and 40.0 mg of the drug (reported earlier in Part I of this series) were evaluated in vivo in eight healthy volunteers in a double-blind study with marketed sustained-release preparations containing 20.0 and 40.0 mg of ISDN. The results were normalized by administering placebo and four conventional ISDN tablets, each containing 5.0 mg of ISDN, to the same group of volunteers in a separate study. The blood pressure of the volunteers was monitored for 8 h. The results indicate that the capsules prepared in the laboratory with the new formulation gave controlled release when compared with the respective marketed SR product.