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Fabrication of efavirenz loaded nano-formulation using quality by design (QbD) based approach: Exploring characterizations and in vivo safety

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Abstract Quality by design (QbD) approach was practically applied in fabrication of nanostructured lipid carrier (NLC) encapsulating efavirenz (EF) to ensure the quality in product. Initially, risk factors were categorized… Click to show full abstract

Abstract Quality by design (QbD) approach was practically applied in fabrication of nanostructured lipid carrier (NLC) encapsulating efavirenz (EF) to ensure the quality in product. Initially, risk factors were categorized based on risk priority number (RPN) using risk identification and assessment tools. A central composite rotatable design (CCRD) was employed to assess the influence of critical process parameter (CPP) (pressure of high pressure homogenizer) and critical material attributes (CMAs) (combination of solid lipid and oil; combination of stabilizers) on responses such as particle size, dispersity and entrapment efficiency. ANOVA was applied to evaluate the data for confirmation of statistical significance (p

Keywords: design qbd; fabrication; quality design; approach; design

Journal Title: Journal of Drug Delivery Science and Technology
Year Published: 2020

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