PEDIATRIC NASAL SPRAY SOLUTION: FACTORIAL DESIGN DEVELOPMENT AND EVALUATION

Abstract

The work was aimed to develope the meter dose formulation of pediatric xylometazoline nasal spray formulation. The 32 factorial design was utilized for development of the pediatric formulation. The independent factors were sodium cholate (X1) and Polyethyleneglycol 400 concentration (X2). The optimized formulation composition consisted of 0.105 g sodium cholate and 1.35 ml polyethyleneglycol 400. The formulation was evaluated for solution parameters like drug content, pH, viscosity, % diffusion, sterility and spray evaluation parameters like spray content uniformity, pump delivery, spray pattern, and weight loss. The results for spray content uniformity were in the range of 95-102 %, while pH in the range of 6.5 ± 0.3. The ovality of spray was 1.118, while perimeter and area of spray pattern were found to be 57.42 mm and 258.8 mm2 respectively for optimized formulation. The least value for repriming was 97.6 % while the extreme value was 102.2 % indicating one actuation was satisfactory for repriming. The results for droplet size test were obtained in the range of 51.63 to 58.90 µm. The formulation along with its container closure was evaluated for its stability up to 12 months at long term conditions. The formulated batch PFE showed better performance for in-vitro drug release with marketed product thus providing another option for treatment of nasal congestion.