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Abstract
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Article Information:
In vitro and in vivo Evaluation of Glibenclamide using Surface Solid Dispersion (SSD) Approach
A.A. Abd Elbary, H.F. Salem and M.E. Maher
Corresponding Author: Heba F. Salem
Submitted: 2010 June, 15
Accepted: 2010 July, 27
Published: 2011 February, 10 |
Abstract:
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The aim of this study is to enhance the solubility of poorly water soluble drugs via the Surface Solid
Dispersion (SSD) strategy using glibenclamide as a model drug. The drug was solubilized by surfactants and/or
polymers then adsorbed onto the surface of extremely fine carriers to increase its surface area and to form the
SSD. Characterization of SSD was carried out using differential scanning calorimetry, X-ray diffraction,
infrared spectroscopy, scanning electron microscopy and in vitro drug release. F5 showed the highest drug
release with r2>0.99. Furthermore, both DSC and X-ray diffraction showed a decrease in the melting enthalpy
and reduced drug crystallinity consequently in SSDs. However, infrared spectroscopy revealed no drug
interactions with the carriers. A bioequivalence study using six male volunteers showed a significant difference
(p = 0.006) between the mean Cmax estimates from F5 tablets (391.21±2.36 ng/mL) and Daonil tablets (296.3±3.18 ng/mL). The t max was 2±0.173 h for the experimental group and 2.5±0.2 h for the control group, which
suggests that enhanced solubility accelerates the absorption of the drug. The two formulas were shown to be
bioequivalent due to lack of significant difference between their mean AUC0-24 . The results indicate that surface
solid dispersion may serve as a successful strategy for enhancing solubility of poorly water soluble drugs.
Key words: Glibenclamide, poor water soluble, surface solid dispersion, , , ,
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Cite this Reference:
A.A. Abd Elbary, H.F. Salem and M.E. Maher, . In vitro and in vivo Evaluation of Glibenclamide using Surface Solid Dispersion (SSD) Approach. British Journal of Pharmacology and Toxicology, (1): 51-62.
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ISSN (Online): 2044-2467
ISSN (Print): 2044-2459 |
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