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INTERNATIONAL JOURNAL OF PHARMACEUTICAL RESEARCH

A Step Towards Excellence
Published by : Advanced Scientific Research
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0975-2366
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IJPR 9[3] July - September 2017 Special Issue

July - September 9[3] 2017

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Assessing the Effect of Process and Formulation Variables on Quality of Solid-Lipid Nanoparticles by Quality by Design Approach

Author: SANDHYA JAISWAL, G.D. GUPTA
Abstract: In the present study, Diltiazem hydrochloride (DTZ.HCL) loaded SLNs were developed using solvent diffusion method in aqueous system. The effect of independent variables on the physicochemical properties of DTZ.HCL-loaded SLNs, such as size and entrapment efficiency (% EE) was evaluated using factorial designing. The optimized formulation was evaluated for their morphology, particle size, zeta potential (ZP), EE and in-vitro drug release kinetics. The response surface plot indicated that the lipid concentration and stirring speed has huge impact on particle size and % EE. The optimized formulation has particle size of 293.69 ± 3.66 nm, ZP of -32.43 ± 3.54 mV and PDI of 0.213. Depending upon the value of coefficient of correlation, the optimized SLNs followed Korsemeyer-Peppas model. The n value was found between 0.5>n>1 which indicates anomalous drug transport followed by non-fickian release mechanism. To conclude, the developed DTZ.HCL-loaded SLNs have potential to enhance the bioavailability of Diltiazem hydrochloride and use the same as a carrier in development of transdermal patch.
Keyword: Diltiazem, Solid-lipid nanoparticles, Statistical optimization, Factorial design, Kinetic modeling, Drug delivery
DOI: https://doi.org/10.31838/ijpr/2020.12.04.080
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