Formulation and characterization of nystatin gel

Abstract

The main objective of this research is to develop and characterize a series of carbopol 934 (CP) hydroxypropyl methylcellulose (HPMC) and a combination of carbopol-HPMC as a gel base for topical delivery of nystatin. The drug level was held constant at 1.72% w/w and the level of propylene glycol which is used as a co-solvent and penetration enhancer was also kept constant at 2% w/w. The total level of the polymer was held constant at 1.5% w/w as a single polymer or combination of two polymers. The polymers combination selected were: carbopol 934 to HPMC at a ratio of 0:1, 1:0, 1:2, 2:1 and 1:1. The batch size was 500 g and triethanolamine was used to adjust the pH of the gel. The rheological study showed that formulation containing combination of 2 carbopol and 1 HPMC ratio gave the highest viscosity, and exhibited an apparent pseudoplastic thixotropic behavior. The diffusion study indicated that gel formulation containing carbopol –HPMC at a ratio of 2:1 gave the highest percent drug diffusion compared to formulation containing low carbopol to HPMC ratio, carbopol alone or HPMC alone. Both in-vitro release and rheological study indicated that carbopol-HPMC had the best gel strength, physical properties and ability to diffuse the drug than carbopol or HPMC alone. The results obtained in this study demonstrated that the combination of carbopol and hydroxypropyl methylcellulose can be used as a gel vehicle for nystatin topical application.