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Related Experiment Videos

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

J K Lalla1, S U Bhat, D M Girappanavar

  • 1Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Bombay, India.

Journal of Pharmaceutical Sciences
|December 1, 1993
PubMed
Summary

New laboratory-formulated Isosorbide dinitrate (ISDN) capsules demonstrated controlled release compared to marketed sustained-release (SR) products. This study evaluated ISDN capsules in healthy volunteers, monitoring blood pressure over 8 hours.

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Area of Science:

  • Pharmacology
  • Drug Delivery Systems
  • Cardiovascular Research

Background:

  • Isosorbide dinitrate (ISDN) is a vasodilator used for cardiovascular conditions.
  • Developing sustained-release (SR) formulations improves therapeutic efficacy and patient compliance.
  • Previous studies (Part I) detailed the formulation of ISDN capsules.

Purpose of the Study:

  • To evaluate the in vivo performance of newly formulated Isosorbide dinitrate (ISDN) sustained-release (SR) capsules.
  • To compare the controlled-release characteristics of the laboratory-developed ISDN capsules against marketed SR preparations.
  • To assess the pharmacokinetic profile and blood pressure effects of ISDN over an 8-hour period.

Main Methods:

  • A double-blind, in vivo study involving eight healthy volunteers.

Related Experiment Videos

  • Administration of laboratory-formulated ISDN capsules (20.0 and 40.0 mg) and marketed ISDN SR preparations (20.0 and 40.0 mg).
  • Normalization of results using placebo and conventional ISDN tablets (5.0 mg); blood pressure monitoring for 8 hours.

    • Main Results:

    • The laboratory-formulated ISDN capsules exhibited controlled-release properties.
    • Comparative analysis showed comparable or improved release profiles versus marketed SR products.
    • Blood pressure monitoring confirmed the pharmacokinetic behavior of the ISDN formulations.

    Conclusions:

    • The novel ISDN capsule formulation provides effective controlled release.
    • The developed formulation shows promise as a viable alternative to existing marketed SR products.
    • Further clinical evaluation may support the use of these ISDN capsules in managing cardiovascular conditions.