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Stability characterization of controlled release coprecipitates and solid dispersions.

M A Khan1, A A Karnachi, V Agarwal

  • 1Department of Pharmaceutical Sciences, Texas Tech University Health Sciences Center, Amarillo, TX 79106, USA. Khan@cortex.ama.ttuhsc.edu

Journal of Controlled Release : Official Journal of the Controlled Release Society
|January 21, 2000
PubMed
Summary

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Ageing indomethacin tablets under harsh conditions significantly reduced drug release. Storage at 4 degrees C maintained drug release, while increased crystallinity was observed, indicating formulation instability.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Controlled release drug delivery systems are crucial for maintaining therapeutic drug levels.
  • Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) commonly formulated for sustained release.
  • Eudragit polymers are widely used in pharmaceutical formulations for controlled drug release.

Purpose of the Study:

  • To investigate the impact of exaggerated storage conditions on the stability and performance of controlled release tablets.
  • To evaluate the effects of ageing on indomethacin-Eudragit coprecipitates (CPs) and solid dispersions (SDs).

Main Methods:

  • Tablets prepared with indomethacin-Eudragit CPs and SDs were stored under various temperature and humidity conditions for six months.
  • Dissolution rates, crystalline reversion, and thermal properties were analyzed using techniques like X-ray diffractometry and Differential Scanning Calorimetry (DSC).

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Main Results:

  • A significant decrease in dissolution rates was observed at extreme temperatures (-20°C, 45°C, 55°C) and high humidity (37°C/91% RH).
  • Tablets stored at 4°C showed no significant change in release rates.
  • Increased crystallinity was confirmed by X-ray diffractometry, indicating potential drug degradation or phase transformation.
  • DSC revealed indomethacin exists in two polymorphic forms (Form I and Form II), with CPs showing Form I and SDs a mixture of both.

Conclusions:

  • Exaggerated storage conditions negatively impact the controlled release performance of indomethacin-Eudragit formulations.
  • Formulation stability is highly dependent on storage temperature and humidity.
  • The observed increase in crystallinity suggests potential instability issues in both CPs and SDs under stress conditions.