Quality by design micro-engineering optimisation of NSAID-loaded electrospun fibrous patches

Kazem Nazari, Prina Mehta, Muhammad Sohail Arshad, Shahabuddin Ahmed, Eleftherios G. Andriotis, Neenu Singh, Omar Qutachi, Ming Wei Chang, Dimitrios G. Fatouros, Zeeshan Ahmad

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    1 Citation (Scopus)
    7 Downloads (Pure)

    Abstract

    The purpose of this study was to apply the Quality by Design (QbD) approach to the electrospinning of fibres loaded with the nonsteroidal anti-inflammatory drugs (NSAIDs) indomethacin (INDO) and diclofenac sodium (DICLO). A Quality Target Product Profile (QTPP) was made, and risk assessments (preliminary hazard analysis) were conducted to identify the impact of material attributes and process parameters on the critical quality attributes (CQAs) of the fibres. A full factorial design of experiments (DoE) of 20 runs was built, which was used to carry out experiments. The following factors were assessed: Drugs, voltage, flow rate, and the distance between the processing needle and collector. Release studies exhibited INDO fibres had greater total release of active drug compared to DICLO fibres. Voltage and distance were found to be the most significant factors of the experiment. Multivariate statistical analytical software helped to build six feasible design spaces and two flexible, universal design spaces for both drugs, at distances of 5 cm and 12.5 cm, along with a flexible control strategy. The current findings and their analysis confirm that QbD is a viable and invaluable tool to enhance product and process understanding of electrospinning for the assurance of high-quality fibres.

    Original languageEnglish
    Article number2
    JournalPharmaceutics
    Volume12
    Issue number1
    DOIs
    Publication statusPublished - 18 Dec 2019

    Keywords

    • Electrospinning
    • Fibres
    • NSAID
    • Oromucosal delivery
    • Quality by design

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