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Effect of aging on the dissolution stability of glibenclamide/beta-cyclodextrin complex
1Department of Pharmaceutics, Banaras Hindu University, Varanasi, India.
Drug Development and Industrial Pharmacy
|December 22, 1999
Summary
Aging does not affect the stability of glibenclamide (GB) complexed with beta-cyclodextrin (CD). Tablets formulated with GB/CD complexes maintain dissolution rates over 4 years, overcoming age-related dissolution issues.
Area of Science:
- Pharmaceutical Science
- Materials Science
Background:
- Glibenclamide (GB) exhibits age-related dissolution challenges.
- Beta-cyclodextrin (CD) complexation is explored to enhance drug stability and dissolution.
Purpose of the Study:
- To investigate the impact of aging on the physicochemical stability of glibenclamide/beta-cyclodextrin systems.
- To evaluate the long-term dissolution performance of glibenclamide/beta-cyclodextrin complexed tablets.
Main Methods:
- Physicochemical stability assessed using Infrared (IR) spectrometry and X-ray diffraction.
- Dissolution rates evaluated for kneaded mixtures, inclusion complexes, and formulated tablets over a 4-year period.
Main Results:
- Product properties remained largely unaffected after 4 years of storage.
- A decrease in crystallinity was observed in glibenclamide/beta-cyclodextrin physical mixtures upon aging.
- Dissolution rates of kneaded mixtures, inclusion complexes, and tablets were stable over the 4-year study.
Conclusions:
- Glibenclamide/beta-cyclodextrin complexation enhances physicochemical stability.
- Formulating glibenclamide with beta-cyclodextrin in tablets overcomes age-related dissolution rate problems.