Design and Optimization of Gastro-Retentive Repaglinide Microspheres by Box-Behnken Design

Author(s)

Patel, D. S., Nashatar, S. A., Patel, K. N., Patel, P. A.

Author's Affiliation

Abstract

The current study involves development and optimization of microspheres based floating system containing Repaglinide by solvent evaporation method for gastro retentive delivery. Combination of polymer Ethyl cellulose and Eudragit RSPO were used to prepare microspheres having poly vinyl alcohol as an emulsifying agent where it sustain the drug delivery upto 12 hr. The effect of various process variables like drug polymer ratio, organic phase addition time and stirring speed on drug release at 2 hr (Q₂), drug release at 8 hr (Q₈) was optimized using box behnken design and analyzed using response surface methodology. The result of FT-IR shows no interaction between drug and polymer. There was an effect on mean particle size by altering drug polymer ratio and stirring speed. The observed responses were coincided well with the predicted values given by the optimization technique. All the batches of microspheres were evaluated for flow properties, % yield, % drug loading, particle size analysis, % buoyancy, in vitro drug release at 2 hr and at 8 hr. The optimized batch MS30 showed the highest % yield (98.34%), % drug loading (55.12%), % CDR at 2 hr (15.79 %) and %CDR at 8 hr (80.01%). The average particle size of optimized batch MS30 was 160 µm. The result of kinetic model of optimized batch MS30 shows non fickian diffusion kinetics. Stability study was performed on optimized batch MS30 as per ICH guidelines and no significant change was found in drug content on storage.

Keywords

Repaglinide, Ethyl Cellulose, Eudragit RSPO, Solvent Evaporation Method

Cite This Article

Patel, D. S., Nashatar, S. A., Patel, K. N., & Patel, P. A. (2013). Design and Optimization of Gastro-Retentive Repaglinide Microspheres by Box-Behnken Design. International Journal for Pharmaceutical Research Scholars (IJPRS), 2(2), 279-294.