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