Strategizing Spray Drying Process Optimization for the Manufacture of Redispersible Indomethacin Nanoparticles Using...

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Indomethacin nanosuspension (IMC-NS) requires optimized drying for improved therapeutic efficacy.
• Spray drying is a critical process for nanoparticle formulation, influencing drug release and stability.
• Quality by Design (QbD) offers a systematic approach to process development and optimization.

Purpose of the Study:

• To develop and optimize an indomethacin spray-dried nanosuspension (IMC-SD-NS) using a Quality by Design (QbD) approach.
• To evaluate the impact of spray drying parameters on critical quality attributes (CQAs) of IMC-SD-NS.
• To characterize the physicochemical properties and in vitro dissolution of the optimized IMC-SD-NS.

Main Methods:

• Utilized Box-Behnken Design (BBD) to investigate effects of inlet temperature, aspiration rate, and feed rate on CQAs.
• Applied regression analysis and ANOVA to identify significant process variables and develop predictive models.
• Characterized IMC-SD-NS using X-ray powder diffraction (XRPD), Fourier transform infrared spectroscopy (FTIR), and in vitro dissolution studies.

Main Results:

• Spray drying parameters significantly influenced redispersibility index (RDI), % yield, and % release at 15 min.
• Developed predictive models for CQAs were statistically significant (p < 0.05).
• Optimized IMC-SD-NS exhibited maintained crystalline state, no drug-excipient interactions, and a 3.82-fold increase in drug release.

Conclusions:

• A QbD-based approach effectively optimized the spray drying of indomethacin nanosuspension.
• The developed IMC-SD-NS demonstrated enhanced dissolution rates attributed to nanosized particles.
• Design of Experiments (DoE) is crucial for developing robust and efficient spray drying processes for nanoparticle formulations.