Preliminary studies for the development of intranasal nanoemulsion containing CNS agent: emphasizing the utilization of cut and weigh method. (3rd April 2017) - Kumar, Amrish
Abstract: Context : The selection of excipients and preformulation strategy plays a vital role for the development of nanoemulsion, due to anatomical and physiological challenges posed by nasal cavity.Objective : This attempt is focused on the selection and optimization of excipients for the development of a nanoemulsion system for intranasal delivery.Materials and methods : Excipients were selected on the basis of solubility of active drug, compatibility interactions and nasal irritancy. Surfactant and co-surfactant combination and their ratio were finalized on the basis of nanoemulsion region obtained from constructed phase diagrams with Capmul MCM as oil phase. A validated cut and weigh method was employed for the optimization of different phase diagrams with respect to nanoemulsion region.Results and discussion : The solubility of drug in Capmul MCM, Labrasol, and Transcutol-P was found to be superior with numeric values of 79.50 ± 1.68 mg/ml, 51.10 ± 1.39 mg/ml, and 36.60 ± 0.85 mg/ml, respectively. On the basis of phase diagram analysis, Labrasol and Transcutol-P in 3:1 ratio provides greater nanoemulsion region of 65.28 ± 0.18%. The validation of cut and weigh method revealed that there was no significant statistical difference ( P > 0.05) with a %RSD value of 2.38 for intersheet variation.Conclusion : The results of validation studies for cut and weigh method suggests that it can be effectively used as an optimization method for the selection of nanoemulsion composition.