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Open AccessArticle

Quality by Design Micro-Engineering Optimisation of NSAID-Loaded Electrospun Fibrous Patches

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The Leicester School of Pharmacy, De Montfort University, The Gateway, Leicester LE1 9BH, UK
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Laboratory of Pharmaceutical Technology, Department of Pharmacy, Aristotle University of Thessaloniki, GR-54124 Thessaloniki, Greece
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The School of Allied Health Sciences, De Montfort University, The Gateway, Leicester LE1 9BH, UK
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Nanotechnology and Integrated Bioengineering Centre, University of Ulster, Jordanstown Campus, Newtownabbey BT37 0QB, Northern Ireland, UK
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Authors to whom correspondence should be addressed.
Pharmaceutics 2020, 12(1), 2; https://doi.org/10.3390/pharmaceutics12010002
Received: 22 October 2019 / Revised: 9 December 2019 / Accepted: 12 December 2019 / Published: 18 December 2019
(This article belongs to the Special Issue Emerging Micro- and Nanofabrication Technologies for Drug Delivery)
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. View Full-Text
Keywords: quality by design; electrospinning; fibres; oromucosal delivery; NSAID quality by design; electrospinning; fibres; oromucosal delivery; NSAID
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MDPI and ACS Style

Nazari, K.; Mehta, P.; Arshad, M.S.; Ahmed, S.; Andriotis, E.G.; Singh, N.; Qutachi, O.; Chang, M.-W.; Fatouros, D.G.; Ahmad, Z. Quality by Design Micro-Engineering Optimisation of NSAID-Loaded Electrospun Fibrous Patches. Pharmaceutics 2020, 12, 2.

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