FORMULATION AND IN-VITRO CHARACTERISATION OF SUSTAINED RELEASE MATRIX PELLETS OF NATEGLINIDE

Objective: Conventionally, sustained release pellets have been prepared in the form of reservoir systems by coating non-pareil pellets which is an expensive and tedious process. The aim of present study was to develop sustained release matrix (SRM) pellets of Nateglinide (NT), an oral antidiabetic agent, commonly used in the treatment of Type 2 Diabetes mellitus. Methods: The SRM pellet formulations of NT were prepared with different polymers like HPMC K4, HPMC K15, Kollidon® SR (K-SR), Hydrogenated castor oil (K-HCO) by extrusion spheronization process. The SRM pellet formulations were characterized for micromeritics properties, aspect ratio, sphericity, friability, Kawakita analysis, Fourier transform infrared spectroscopy (FTIR), drug content and In vitro drug release studies. Results: The optimized formulation of SRM pellets (Batch F7) prepared by using K-SR (35%w/w) and K-HCO (15 %w/w) has shown desired sphericity and excellent micromeritics properties. The friability and drug content value were found in the range of 0.22- 0.81% and 96.8-99.7% respectively for all formulations. FTIR spectroscopy studies have not revealed any chemical interaction between the NT and excipients. The Kawakita plot of F7 showed good flow ability with ‘a’ value 0.4537 and ‘b’ value 0.0029. The sustained release profile showed 53.63% drug release at 6 hrs and 100% drug release within 12 hrs and Higuchi kinetic model was followed by drug release. Conclusion: Thus, Nateglinide sustained release matrix pellets can be explored for commercial manufacturing instead of conventional reservoir pellets.