DESIGN UTILIZING BILE SALT SURFACTANTAND IN VITRO EVALUATION: IMIDAZOLE CLASS DRUG NASAL SPRAY FOR TREATMENT OF NASAL CONGESTION

The objective of the present work is to develop the meter dose nasal formulation of xylometazoline hydrochloride with a view to improve the effectiveness as nasal decongestion. The 3² factorial experimental design was employed for optimization of sodium cholate (X₁) and PEG 400 concentration (X₂) in the formulation. All the possible experimental trials were carried out according to design layout. The experimental model was further validated by six check point batches. The optimized formulation contains 1.5% w/v sodium cholate and 20% v/v PEG 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. The percentage diffusion and viscosity were observed 89.33 ± 0.57% and 25.33 ± 0.57 centipoise respectively. For spray pattern of optimized formulation, the ovality obtained was 1.217, while perimeter and area were found to be 104.56 mm and 791.5 mm² respectively. The meter dose nasal formulation shows the superior performance during in-vitro drug release compared with currently marketed formulations, which provides alternative option for treatment of nasal congestion.