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Related Experiment Videos

Controlled-release isosorbide dinitrate pellets. Part I: Design and evaluation of controlled-release capsule dosage

J K Lalla1, S U Bhat

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

Journal of Pharmaceutical Sciences
|December 1, 1993
PubMed
Summary

New 8-hour controlled-release isosorbide dinitrate capsules were developed. Storage studies revealed that temperature and humidity accelerate drug degradation, necessitating controlled packaging.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Formulation Development

Background:

  • Isosorbide dinitrate is a vasodilator used for angina.
  • Developing controlled-release formulations improves therapeutic efficacy and patient compliance.
  • The need for stable, long-acting isosorbide dinitrate formulations is critical.

Purpose of the Study:

  • To design and evaluate 8-hour controlled-release isosorbide dinitrate capsules.
  • To assess the in vitro drug release characteristics.
  • To investigate the stability of the formulation under various storage conditions.

Main Methods:

  • Formulation of 20.0 mg and 40.0 mg isosorbide dinitrate capsules.
  • In vitro dissolution testing to evaluate drug release kinetics.

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  • Accelerated stability studies at elevated temperatures (30°C, 40°C) and humidity (72%, 90%).
  • Main Results:

    • The developed capsules demonstrated 8-hour controlled-release properties.
    • Both temperature and relative humidity significantly accelerated the degradation of isosorbide dinitrate.
    • Degradation rates increased with higher temperatures and humidity levels.

    Conclusions:

    • The controlled-release isosorbide dinitrate capsules meet the desired release profile.
    • The formulation's stability is compromised by elevated temperature and humidity.
    • Controlled packaging conditions are essential during the manufacturing and storage of these capsules to ensure drug integrity.