Intranasal delivery of venlafaxine loaded nanostructured lipid carrier: Risk assessment and QbD based optimization
作者： Brijesh Shah , Dignesh Khunt , Himanshu Bhatt , Manju Misra , Harish Padh
DOI: 10.1016/J.JDDST.2016.03.008
关键词:
摘要: Abstract The objective of the present investigation was to optimize and develop venlafaxine (VLF) loaded nanostructured lipid carrier (NLC) using QbD risk assessment approach. Full factorial 3 2 design applied two independent variables viz ., X1: Drug total ratio X2: Surfactant concentration whereby their effect on dependent Y1: Size, Y2: PDI Y3: %EE studied. Compritol 888 ATO Capmul MCM EP showed highest solubility for VLF as solid liquid respectively which depicted superior miscibility at solid: 70:30% w/w. NLC were formulated based optimized formula obtained from space gave experimental values CQA (Size: 77.08 ± 3.45 nm, PDI: 0.234 ± 0.062 %EE: 81.33 ± 3.05). FTIR, DSC XRD studies revealed formation less ordered crystalline structure matrix favouring higher encapsulation VLF. Ex-vivo diffusion study flux value with (14.2 ± 0.40 μg/cm /h) in comparison solution (9.62 ± 0.59 μg/cm across goat nasal mucosa. did not show toxicity mucosa intact indicating safety intranasal administration. Overall, approach sounds be apt successful development NLC.
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