Abstract
The aim of the present study was to investigate the in-vitro release rate of diazepam from a commercially available sustained-release preparation using the flow-through dissolution apparatus (USP apparatus 4) and a dissolution permeation apparatus developed in these laboratories, and to investigate the in-vitro permeation rate of diazepam using the latter. The release profiles of diazepam at pH 6.9 and 7.2 were very similar for both apparatuses tested. At pH 1.5 the release of diazepam is much lower, and at pH 4.5 the release is the lowest (20–25%). The permeation profiles of diazepam for the dissolution permeation apparatus at pH 6.9 and 7.2 are very similar. At pH 1.5 the permeation of diazepam is much lower and at pH 4.5 the permeation is practically undetectable, presumably because of the very low diazepam concentration in the donor compartment. As the pH of enteric fluids may vary depending on several physiological conditions, diazepam release and absorption must be conditional on previous study of those pH variations. Both apparatuses used showed a similar release profile for the various release conditions, and we can therefore consider them as equivalent for this kind of study.
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