DEVELOPMENT OF SUSTAINED RELEASE DOSAGE FORM OF GLICLAZIDE

Abstract

The main aim of present work was to prepare solid dispersion of poorly water soluble drug Gliclazide to enhance its in-vitro dissolution rate and aqueous solubility of drug. Gliclazide is a second generation of hypoglycemic sulfonyl urea. The major drawback in the therapeutic application and efficacy of Gliclazide as oral dosage forms is its very low aqueous solubility because of its hydrophobic nature. It has short biological half-life, small dose (30-80 mg) hence suitable for solid dispersion and sustained release formulation. In present study, polyethylene glycol 6000 and PVP K-30 were selected as carrier because of their chemical and pharmacological inertness. Polyethylene glycol 6000 and PVP K-30 by virtue of their water solubility leads to high degree of solubilization of poorly soluble drug. After comparing the solubility and dissolution profiles of various solid dispersions, it was observed that solid dispersion such as SDPEG ½ or SDPVP ½ gave desired dissolution profile of Gliclazide (more than 80% release in first 120 min). In-vitro dissolution studies also revealed that SDPVP K-30 ½ has shown less percentage of drug release from tablet for first two to three hours than SDPEG ½. It may due to binding effect of PVP K-30.

KEY WORDS: Gliclazide, Poorly water soluble, In-vitro dissolution, solid dispersion, Matrix tablet