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Development and Optimization of Multiple-Unit Floating Drug Delivery System of Pregabalin Using Quality by Design (QbD) Approach
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| Author:
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MONIKA KHARB, Y.S.TANWAR
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| Abstract:
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The aim of current study was to develop multiple-unit floating drug delivery system, i.e. floating microspheres of pregabalin using quality by design based approach. In first step, quality target product profile and critical quality attributes were selected. Floating microspheres were prepared using solvent evaporation method using hydrophilic (poly vinyl pyrrolidone) and hydrophobic (ethyl cellulose) polymer in combination. Risk assessment matrix and Ishikawa fish bone diagram were used for selection of parameters highly influencing critical quality attributes (practical yield, encapsulation efficiency, floating ability and time required to 60% drug release). A Taguchi design was used for selection of critical parameters. The selected critical parameters were drug: polymer, poly vinyl pyrrolidone: ethyl cellulose and dichloromethane : methanol and Box-Behnken Design was employed for optimization of these critical parameters. The design space was defined overlaying the contour plots yielding smaller particle size, excellent encapsulation efficiency and floating ability, and sustained drug release. The optimized floating microspheres have shown excellent encapsulation efficiency, floating ability and sustained drug release up to 12 hr. The results leads to the conclusion that multiple-unit floating drug delivery system for pregabalin was successfully developed using QbD approach.
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| Keyword:
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Multiple-unit drug delivery, Quality by Design, Pregabalin, Box Behnken Design, Taguchi design, Optimization
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.366
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| Download:
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