Research Article
Journal of Pharmaceutical Sciences
Volume 82 Issue 12, Pages 1288 - 1291
Published Online: 21 Sep 2006
Copyright © 2009 Wiley-Liss, Inc., A Wiley Company
Controlled-release isosorbide dinitrate pellets. Part I: Design and evaluation of controlled-release capsule dosage form
J. K. Lalla *, Shruti U. Bhat
Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Plot No. 47, DR. R. G. Thadani Marg, Worii Sea Face, Bombay, 400 018, India
or Shruti Bhat at http://www.drshrutibhat.com
*Correspondence to J. K. Lalla, Department of Pharmaceutics, Principal K. M. Kundnani College of Pharmacy, Plot No. 47, DR. R. G. Thadani Marg, Worii Sea Face, Bombay, 400 018, India.
Design and evaluation of 8-h controlled-release isosorbide dinitrate capsules representing 20.0 and 40.0 mg of the drug are described. The formulation conforms to the total drug incorporated in the dosage form. In vitro dissolution studies indicate that the formulations behave as controlled-release dosage forms. Studies of storage at 30 ± 2 and 40 ± 2 °C at relative humidities of 72.0 and 90.0%, respectively, indicate that both temperature and humidity accelerate the degradation of the formulation. These results indicate the need of controlled packaging conditions during manufacture of these capsules.

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