Design and evaluation of prolonged release gliclazide matrix tablets
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Date
2007
Authors
Abdelkareem Adam, Fathlrahman Abdelraziq
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Abstract
The prolonged release gliclazide matrix tablets were prepared using polymeric
materials, namely, HPMC, Kollidon SR, Carbopol with Xanthan gum, Eudragit
RSPO and Eudragit RLPO. HPMC, Kollidon SR and Carbopol with Xanthan
gum were able to retard gliclazide release from matrix tablets in a concentration
dependent manner, but the rate of retardation differed among the polymers. On
the other hand, drug release from matrix tablets containing Eudragit RSPO and
Eudragit RLPO, was independent of the amount of polymer used, and no
consistent drug release pattern was observed. Among the various types of
polymers and concentrations studied, the dissolution profile of matrix tablets
containing 6% HPMC (formulation H2) was found to be similar to that of
Diamicron MR tablets as indicated by the values of similarity factor and
difference factor. In addition, the drug release of formulation H2, was not
affected by changes in pH but affected drastically by changes in the stirring
rate. Prior to the in vivo study, a simple, sensitive, and specific isocratic HPLCUV
method for the determination of gliclazide concentration in rabbit plasma
was developed and validated. A liquid-liquid extraction method was used in the
sample treatment. The assay method was used in the pharmacokinetic study of
gliclazide, comparing formulation H2 and Diamicron MR as a reference
product. Four rabbits were used in the in vivo evaluation. There was no
statistically significant difference between formulation F2 and Diamicron MR in
the values of Tmax, Cmax and AUC. In conclusion, the rate and extent of
absorptions of gliclazide for formulation H2 was comparable with Diamicron
MR.
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Keywords
Prolonged release