Quality-By-Design (QBD) Approach in Developing a Thermoresponsive In-Situ Nasal Gel Containing Nanosized Antiviral

Design of patient acceptable and effective drug delivery systems is a major concern area in pharmaceutical research field especially when the aim is management of nasal and respiratory infections. This paper was an attempt to design and optimize a thermoresponsive in-situ nasal gel made with nanosized antiviral agent using Poloxamer 407, Poloxamer 188, and HPMC as variables of the formulation. To determine the impact of these variables on the gelation temperature, viscosity and drug release, a Box- Behnken design was used together with Response Surface Methodology (RSM). ANOVA showed the effect of three excipients to be significant (p < 0.05), and the R 2 values were over 0.95, which represents considerable stability of the model. Optimized formulation displayed gelling temperature in the physiological range, a favorable drug delivery (gel) viscosity tailored to administrable in nasal cavity through nasal spray, and sustained drug release which was supported by predictive modelling and in-vitro tests. The results indicate the possibility of increasing drug bioavailability and mucosal adhesion and developing a fast onset of therapeutic effects with this formulation, so it should be considered one of the candidates in clinical translation.