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Hoang Trinh, Kishore Cholkar, Ashim K Mitra; Development and optimization of clear, aqueous triamcinolone acetonide eye drop. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4144. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
There are almost 18.8 million people suffering from diabetes in U.S and this population develops diabetic macular edema (DME) or retinopathy during their life time. Triamcinolone acetonide (TA) is an anti-inflammatory and anti-angiogenic drug indicated for treat back of the eye diseases to reduce the central macular thickness.<br /> The purpose of this study is to develop, optimize, characterize and evaluate toxicity of triamcinolone acetonide loaded clear aqueous mixed nanomicellar formulation
A full factorial design was selected from screening design to predict response variables. Amount of Polymer 1 and Polymer 2 were selected as independent variables. Percent triamcinolone acetonide entrapment, loading and critical micellar concentration (CMC) were evaluated as dependent variables. Formulations were prepared by solvent casting/film hydration method. Response data was analyzed with standard least square fit analysis. Based on t-test, variables which had significant effect were determined. For optimization process, prediction profiler was generated to predict the levels of independent variables allowing maximum entrapment efficiency, loading efficiency while minimizing CMC
The formulation was prepared with predicted polymer ratio, Polymer 1 and Polymer 2 (5:1.5). The results were in agreement with predicted profile. Furthermore, all formulations were characterized for micelle size, polydispersity index, zeta potential, and viscosity. Qualitative 1H NMR studies confirmed the absence of free triamcinolone acetonide in aqueous solution. In vitro biocompatibility of formulations studies with WST-1 reagent assay produced no toxicity on human cornea epithelical cells (HCEC)
In conclusion, an aqueous, clear mixed nanomicellar triamcinolone acetomide loaded formulation is successfully prepared with the aid of Polymer 1 and Polymer 2.
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