Abstract

DEVELOPMENT AND CHARACTERIZATION OF NANOSUSPENSION FOR SOLUBILITY ENHANCEMENT OF DIFLUNISAL

Muskan Singh Bais*, Dr. Tanu Bhargava, Prof. Kamlesh Dashora

Abstract

Diflunisal is a poorly water-soluble non-steroidal antiinflammatory drug, which results in ppor aqueous solubility. The present study aimed to develop and characterize a nanosuspension of diflunisal to enhance its solubility and dissolution behavior using the nanosuspension approach. The nanosuspension was prepared by the solvent–antisolvent precipitation method employing polyvinylpyrrolidone K30 (PVP K30) as a stabilizer. Various drug-to-stabilizer ratios (1:1, 1:2, 1:3, 1:4 and 1:5) were investigated to optimize the formulation. Among the prepared formulations, F2 was identified as the optimized batch, exhibiting a particle size in the range of 519–525 nm with a low polydispersity index of 0.0382, indicating uniform particle size distribution. The optimized formulation showed a zeta potential of −33.3 mV, confirming good physical stability. Fourier transform infrared (FTIR) analysis indicated no significant drug–excipient interactions. In vitro drug release studies revealed a marked improvement in dissolution, with formulation F2 achieving approximately 90% drug release within 180 minutes. Release kinetics followed a first-order model. Stability studies demonstrated that the optimized nanosuspension remained physically and chemically stable. The developed diflunisal nanosuspension proved to be an effective strategy for enhancing solubility and dissolution of poorly water-soluble drugs.

Keywords: Diflunisal; Nanosuspension; Solvent–antisolvent precipitation; PVP K30; Solubility enhancement; In vitro drug release.