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Evaluation of Accelerated Stability Testing of a Mirtazapine-loaded Nanoemulsion as per International Conference on Harmonization (ich) Protocols

Ezealisiji M. Kenneth, Siwe Noundou Xaveir, Mbah C. John, Osadebe O. Patience, Rui Krause

Abstract


Remarkable alteration in bio – therapeutic toxicity may occur as a result of physicochemical deterioration of active pharmaceutical ingredients or drugs hence the need for drug stability studies. The aim of this research was to investigate the stability of mirtazapine in nano-emulsion and to establish the shelf life of mirtazapine in the formulation. Nanoemulsion was prepared by spontaneous emulsification method (titration method). Thermodynamic stability studies on the nanoemulsions were performed at various temperatures. Particle sizes, polydispersity index, zeta potential were used to characterize the nanoemulsions. Physicochemical properties were determined on the optimized nanoemulsions using standard methods. Mirtazapine was incorporated into the oil phase in 1.5 % w/v to give an oil/water nanoemulsion formulation. The ICH protocols were observed in carrying out the stability studies for a period of three months. Determination of the shelf life of the nano-emulsion formulation was achieved following accelerated stability studies at 4 ± 0.7°C, 25± 0.5°C, 40± 0.5°C, 50± 0.4°C and 65 % ± 5 relative humidity (RH). Result showed that the droplet size, conductivity, refractive index were slightly increased while the pH and viscosity slightly decreased during the 3 months period. The observed slight changes in the parameters were not statistically significant (p ≥ 0.05). The shelf life was found to be 2.88 years at room temperature. The degradation (%) of the optimized mirtazapine nanoemulsion was determined. This research work confirmed that the physicochemical stability of mirtazapine was enhanced in the nanoemulsion.


Keywords


Nano-emulsion; Mirtazapine; Shelf-life; ICH; Conductivity; Viscosity

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