Studies on Formulation Development and Evaluation of Nasal Delivery System of Xylometazoline

Abstract

Sinusitis is one of the major factor which boost complications during the upper respiratory tract infections treatments. The epidemiology data shows 15 to 40 cases per 1000 patients per annum. The objective of the present work is to develope the meter dose nasal formulation of xylometazoline hydrochloride for improved effectiveness of acute sinusitis and nasal decongestion treatment for adult and child. The 32 factorial design was employed using concentration of sodium cholate and PEG 400 as independent variables for formulation development of xylometazoline nasal solution. The % diffusion at 10 minutes and viscosity were selected as dependent variables. The contour and the response surface plot were constructed using Design Expert software. Batch FA5 containing 0.1 gm of sodium cholate and 1.5 ml polyethylene glycol 400 was selected as optimized formulation. Checkpoint batches were formulated to validate the evolved polynomial equation. The optimized nasal solution was subjected to in vitro drug diffusion using Franz diffusion cell to evaluate drug release as compared to Otrivin® nasal solution. The nasal spray solution was formulated and evaluated for spray parameters like pump delivery, spray pattern, spray content uniformity, droplet size distribution and weight loss, and the results were found satisfactory. The results of stability study revealed that xylometazoline nasal solution was stable. Nasal drug delivery route is considered as critical route for drug delivery.In the study, the goal was to develope and evaluate the nasal Insitu gel of xylometazoline hydrochloride to prolong the therapy of nasal congestion. newline