Design and Evaluation of Solid Dispersed Gliclazide TabletsAuthor(s): A. Prameela Rani, R. Santosh Kumar, N. Archana, B. Aruna and P. Sivatheja
Gliclazide (GZ), an oral hypoglycemic agent, belongs to BCS class II. It is poorly soluble in water (5.23 1g/mL) and requires enhancement in solubility and dissolution rate for increasing its oral bioavailability. In the present investigation, solid dispersed systems of GZ were prepared using polyethylene glycol (PEG-6000) and poly vinyl pyrrolidine (PVP k25). The feasibility of employing solid dispersion technique for enhancing the solubility and dissolution rate was investigated. The aqueous solubility of GZ was increased linearly as a function of the concentration of polymers used in the study. PVP gave higher enhancement in the solubility and dissolution rate when compared to PEG tested. Characterization of co-evaporates was studied by DSC thermograms. Solid dispersions of gliclazide- PVP prepared by co-evaporation were developed into tablet dosage forms by wet granulation method. The solid dispersion tablets were evaluated and compared with some of the gliclazide conventional tablets, which are commercially available. Solid dispersion tablets of co-evaporation method showed better correlation with marketed formulations.