Abstract

FORMULATION AND CHARACTERIZATION OF NATEGLINIDE LOADED SOLID LIPID NANOPARTICULATE CAPSULES FOR THE TREATMENT OF TYPE II DIABETES MELLITUS

Karthickrajan N.*, Daisy Chella Kumari S., Elango K., Velmurugan K.

ABSTRACT

Nateglinide is a novel non-sulfonylurea oral hypoglycaemic agent which has outstanding clinical effectiveness in the treatment of Type II diabetes mellitus. The aim of the present study was to prepare and characterize Nateglinide loaded Solid lipid nanoparticulate capsules to improve the therapeutic efficacy and reducing the frequent dosing. Hot homogenization followed by ultra sonication method was employed using glyceryl behenate as a lipid with various drug-lipid ratios for the preparation of solid lipid nanoparticles and optimized formulation filled in hard gelatin capsules. Characterization techniques followed for the formed solid lipid nanoparticles were drug content, entrapment efficiency; in vitro drug release, particle size analysis, morphology and optimized formulation were filled hard gelatin capsules and evaluation of nanoparticulate capsules, kinetic drug release and stability studies. The drug-lipid ratio showed remarkable impact on drug content, entrapment efficiency. The solid lipid nanoparticles were then loaded in capsules followed by in vitro drug release study, SEM micrographs revealed that solid lipid nanoparticles are circular in shape with smooth surface. Which depicted that solid lipid nanoparticles with drug - lipid ratio 1:3 was more proficient to give controlled release at the end of 12 h. the flow property measurements for optimized formulation observed good flow were its filled in capsules and evaluate uniformity of weight, disintegration test, drug content and in vitro drug release for capsules. The uniformity of weight, disintegration test, drug content complies with official specifications and Accelerated stability studies revealed that the formulation is stable as per International Council on Hormonisation guidelines.

Keywords: Solid lipid Nanoparticles, Nateglinide, Hot homogenization method, Glyceryl behenate (Compritol 888 ATO), Poloxomer.