Formulation and Evaluation of Fluticasone Furoate and Oxymetazoline Hydrochloride Nasal Spray for treatment of Allergic rhinitis
Abstract
The aim of this study was to develop and assess a nasal delivery system containing Fluticasone furoate and oxymetazoline hydrochloride for treating allergic rhinitis. A colloidal dispersion of fluticasone furoate and oxymetazoline hydrochloride was utilized for the nasal drug delivery system, with Benzalkonium chloride (BKC) included as a preservative. The final formulation incorporated citric acid as an acid-modifying agent, sodium citrate as a buffering agent, polysorbate 80 as a surfactant, and MCC and CMC (Avicel 591) as viscosity-modifying agents. The formulation underwent evaluation for various parameters including pH, clarity, viscosity, drug content, spray content uniformity, pump delivery, spray pattern, plume geometry, droplet size distribution, priming, and repriming. Spray content uniformity ranged from 85% to 115%, while the pH was between 4 and 6. The spray pattern had an ovality of 1.121, with a perimeter of 113.42 mm and an area of 9.671 mm². The plume geometry had a mean spray angle of 59.0°, Plume Width 67.83 mm and Plume Length: 60 mm. The repriming efficiency varied between 83.9% and 100.1%, indicating satisfactory performance. Droplet size distribution was found to be between 25 and 30 µm. The formulation, along with its container, was tested for stability under accelerated conditions for up to three months. The results suggest that this formulation is a viable option for allergic rhinitis treatment, demonstrating comparable performance to existing marketed products.
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