Objective: The main aim of this study was to formulate, develop and optimized a duloxetine hydrochloride (dlx-hcl) loaded mucoadhesive microemulsion intended for intranasal administration. Methods:Established on solubility studies capmul mcm, transcutol-p, labrasol were used as oil, co-surfactant and surfactant respectively. The optimized mucoadhesive microemulsion prepared using water titration method was further characterized for particle size, polydispersity index, zeta potential and conductivity measurements followed by drug content, nasal cilio toxicity and biochemical estimation of the selected formulation.Results: All physicochemical parameters conducted, proved that dlx-hcl microemulsion was appropriate for nasal delivery. Chitosan, used as mucoadhesive polymer demonstrated enhanced retention time of the microemulsion in nasal mucosa with no signs of toxicity and epithelial damage. The particle size and zeta potential were found to be of 200 nm and-15 mV respectively considering the formulation safe for nasal delivery. Conclusion:This formulation strategy can be used as an effective targeting technique for the drugs having low bioavailability and poor brain penetration along with an effective method for the treatment long-term disease like depression.

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Background : Nanotechnology has been one of the most prominent forefront grounds in several traditional research areas of science and technology, and development of medicines at nanoscale can be reflected by the tremendous surge in market interest. Present outlook: Its applications include various research areas of medicine, drug delivery technology, diagnostic devices, tissue engineering and gene therapy. Along with immense advances, this technology comes with major limitations including potential immune reactivity and complex characterization of these products. Regulatory Challenges: The lack of a proper regulatory perspective due to infidelities in scientific findings have led to further uncertainties and vagueness of the nanoscale domain, particularly its safety implications. Guideline Scenario: Early development pathways and regulations should be a top-notch priority to help researchers fail faster and more economically. This would facilitate the peaking utility of these materials in medicine without compromising public health and environmental integrity. This review attempts to emphasize the regulatory rationales of key considerations in nanotechnology along with a portray of the present scenario.

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