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

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Electrospinning is a versatile technique for producing nanofibers for drug delivery.
• Optimizing electrospinning processes is crucial for consistent drug loading and release.
• Quality by Design (QbD) principles offer a systematic approach to process development and control.

Purpose of the Study:

• To apply the Quality by Design (QbD) approach to the electrospinning of indomethacin (INDO) and diclofenac sodium (DICLO) loaded fibers.
• To identify critical material attributes and process parameters impacting the critical quality attributes (CQAs) of NSAID-loaded fibers.
• To establish design spaces and control strategies for reproducible electrospinning of high-quality drug-loaded fibers.

Main Methods:

• Development of a Quality Target Product Profile (QTPP) and preliminary hazard analysis.
• Utilizing a full factorial design of experiments (DoE) with factors including drug type, voltage, flow rate, and needle-collector distance.
• Employing multivariate statistical analysis to define design spaces and control strategies.

Main Results:

• Indomethacin (INDO) fibers showed a greater total release of active drug compared to diclofenac sodium (DICLO) fibers.
• Process parameters, specifically voltage and distance, were identified as the most significant factors influencing fiber quality.
• Six feasible and two universal design spaces were established for both drugs, alongside a flexible control strategy.

Conclusions:

• The Quality by Design (QbD) approach is a valuable tool for enhancing product and process understanding in electrospinning.
• QbD facilitates the assurance of high-quality drug-loaded fibers through systematic development and control.
• This study demonstrates the successful application of QbD to optimize electrospinning of NSAID-loaded fibers, paving the way for improved drug delivery systems.