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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


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.


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

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Sanjay B, Dienesh S, Neha S. Stability testing of pharmaceutical products. J Applied Pharm Sci. 2012; 02 (03):129-138

Anuja D, Ganesh D, Varsha A, et al. Review of Nanoemulsion: A novel drug delivery system. European J Biomed Pharm Sci. 2016, 3 (4) 156-166

Raj KM, Soni GC, Mishra RP. A Review Article: On Nanoemulsion. World J Pharm Pharm Sci. 2014, 3 (9) 258-274

Jiao J, Burgess DJ. Ostwald ripening of water–in-hydrocarbon. J Colloid Interface Sci. 2003, 264 (2) 509-516

Ee SL, Duan X, Liew J, et al. Droplet size and stability of nanoemulsion produced by the temperature phase inversion method. J Chem Eng. 2008, 140:626-631

Capek I. Degradetion of kineticaly stable o/w emulsions. Advances in colloid and Interfacial Sci. 2004, 107:125-155

Skartlien R, Grimes B, Meakin P, et al. Coalescence kinetics in surfactant stabilized emulsions; Evolution Equations From Direct Numerical Simulations. J Chem Phys. 2012, 137(21), 214-232.

Akbari B, Tavandashti MP, Zandrahimi M. Particle Size Characterization of Nanoparticlea- A practical approach. Iranian J Material Sci & Eng. 2011, 8(2),138-146

Baranowski P, Karolewicz B, Gajda M, et al . Optalmic Drug Dosage forms: Characterisation and Research Methods. The Sci World J. 2014,

Ezealisiji KM, Mbah CJ, Osadebe PO. Aqueous Solubility Enhancement of Mirtazapine: Effect of Cosolvent and Surfactant. J Pharmacol. and Pharm. 2015, 3 (6) 471-476

Sonal S, Poornima N, Razdan BK, et al . Design, development and in-vitro investigation of water in oil. Nanoemulsion for Transdermal Delivery. 2014 , 3 (12) 1495-1512

Mohamed A. The Rheological Properties of Different GNPs. J Lipid Health Dis. 2012 ;11:14

Carless JE, Swarbrick J. The solubility of benzaldehyde in water as determined by refractive index measurements. J Pharm Pharmacol. 1964, 16 (9) 633-634

Nagahiro HY, Micheal SR. Prediction of Cathode Iontophoretic Transport of various Anions Across Excisized Skin from different vehicles using conductivity measurements. J Pharm Pharmcol. 1995, (11), 883-890.

Sambasivarad A, Chandra SRB, Reddy MH. Accelerated Stability Testing of Dosage forms as per ICH Guidelines. World J Pharm and Med Res. 2016, 2 (3) 99-103

Chard MS, Shinde MM, Welankiwa AS, et al . Development of Analytical and Stability Testing Method for Vitamin-A Palmitate Formulation. Inter. J Pharm Chem. 2014, 04 (01) :567-576


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