Factorial Design Methodology for Development of Pediatric Nasal Spray: Study on Xylometazoline Nasal Solution Used For Treatment of Nasal Congestion

Abstract

Objective: The objective of the present work is to develop the meter dose pediatric formulation of xylometazoline hydrochloride for enhanced effectiveness for nasal decongestion. Experimental Work: The 32 factorial experimental design was employed for optimization of sodium cholate (X1 ) and Polyethyleneglycol 400 concentration (X2 ) in the formulation. The optimized formulation contains 1.18 % w/v sodium cholate and 13 % v/v Polyethyleneglycol 400. The formulation was further evaluated for its drug content, pH, viscosity, spray content uniformity, In vitro-diffusion studies, pump delivery, spray pattern, sterility and stability study.Results: The percentage diffusion and viscosity was observed 91.33 ± 1.15 % and 19.33 ± 0.57 centipoise respectively. The meter dose nasal formulation shows the superior performance during in-vitro drug release compared with current marketed formulations, which provides alternative option for treatment of nasal decongestion

Keywords: Nasal congestion; Factorial design; Meter dose formulation; Xylometazoline; hydrochloride; Sodium cholate