Statistical Design for Formulation Optimization of Diclofenac Sodium-Loaded Ethylcellulose Microsponges

Abstract

For a better use of the drug, a decrease in side effects, an improvement in effectiveness, and a uniform release of the active ingredients, sustained-release forms have been developed. The objective of this study is to estimate the effect of the factors on the responses involved in the formulation of Diclofenac Sodium (DC) loaded ethylcellulose (EC) microsponges (MP) using Central Composite Design (CCD). Quasi emulsion solvent diffusion method was used to formulate MP. The ratio of ethylcellulose to Diclofenac Sodium and polyvinyl alcohol (PVA) concentration (w/v%) were selected as independent variables for CCD. Entrapment efficiency (EE) and production yield (PY) were selected as dependent variables. The optimal formulation was characterized by Fourier Transform Infrared (FTIR), Optical Microscopy, and in vitro release. Optimized MP showed an EE of 31.02% and a PY of 66.44%, FTIR studies revealed no chemical interaction between drug and polymer used, MP were spherical and present an average size of 9.21±0.3µm. Kinetic studies revealed that drug release from optimized formulation followed Higuchi model. The results demonstrated the effectiveness of proposed design for development of DC microsponges for the sustained release.