Drugs may lose their therapeutic efficacy and potentially develop harmful consequences due to physical and chemical degradation. Therefore, the aim of this work is to study the physical stability and degradation kinetics of Mirtazapine (MRT) loaded aquasomes in situ nasal gel and calculate the shelf life of the tested formula. International Conference on Harmonization (ICH) protocols were followed in conducting the stability tests. MRT was prepared as nanoparticles called aquasomes and incorporated into a nasal gel. Four gelling polymers were used in this study, namely HPMC K4M (F1), carbopol (F2), chitosan (F3), and carrageenan (F4). The formulations were kept in storage for six months at 4 ± 2 °C, 25 ± 2°C and 65 % ± 5 relative humidity (RH). As a consequence, each gel formulation is assessed for its physical stability, including its clarity, pH, gelation temperature, and gelling time. The drug content, degradation kinetics, and shelf life of the nasal gel formulation were also calculated. The study's results demonstrated that the tested formulae were physically stable during the period of testing with very slow degradation and were found to be of zero order, Variations in the characteristics were not statistically significant by using one-way ANOVA analysis. The shelf life of the Arrhenius plot ranged from 1.333 years (F3) to 2.2 years (F1). The results indicate that the stability of MRT-loaded aquasomes in situ nasal gel is acceptable and stable. Furthermore, HPMC K4M shows higher stability and longer shelf -life.
Go Back