Acta Pharm. 61 (2011) 323-334

 

full paper

Original research paper

 

Dissolution rate enhancement of gliclazide by ordered mixing

VIKAS A. SAHARAN and PRATIM K. CHOUDHURY

vikas.pharmaceutics@gmail.com

1 Institute of Pharmaceutical Sciences and Drug Research, Seth G.L. Bihani S.D. College of Technical Education, Sri Ganganagar, Rajasthan, India

2 Department of Pharmaceutical Sciences, M.L. Sukhadia University, Udaipur, Rajasthan, India

Accepted June 7, 2011

 

The poorly water soluble antidiabetic drug gliclazide was selected to study the effect of excipients on dissolution rate enhancement. Ordered mixtures of micronized gliclazide with lactose, mannitol, sorbitol, maltitol and sodium chloride were prepared by manual shaking of glass vials containing the drug and excipient(s). Different water soluble excipients, addition of surfactant and superdisintegrant, drug concentration and carrier particle size influenced the dissolution rate of the drug. Dissolution rate studies of the prepared ordered mixtures revealed an increase in drug dissolution with all water soluble excipients. The order of dissolution rate improvement for gliclazide was mannitol > lactose > maltitol > sorbitol > sodium chloride. Composite granules of the particle size range 355-710 µm were superior in increasing the drug dissolution rate from ordered mixtures. Reducing the carrier particle size decreased the dissolution rate of the drug, as well as the increase in drug concentration. Kinetic modeling of drug release data fitted best the Hixson-Crowell model, which indicates that all the ordered mixture formulations followed the cube root law fairly well.

 

Keywords: gliclazide, excipient, dissolution, solubility, ordered mixture