Optimization of Spray-Drying Parameters for Formulation Development at Preclinical Scale.

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Chemical Engineering

Background:

• Spray-drying dispersion (SDD) is crucial for creating amorphous solid dispersions (ASDs) to enhance the bioavailability of poorly soluble drugs.
• The complex nature of spray-drying processes often leads to extended development timelines and high resource demands, hindering preclinical development.

Purpose of the Study:

• To establish optimized, preset spray-drying parameters for the early development of amorphous solid dispersions (ASDs).
• To create a versatile and efficient spray-drying approach applicable across various formulations and scales, reducing individual optimization needs.

Main Methods:

• A mini-Design of Experiments (DoE) study was conducted using a mini spray dryer to assess the impact of solid load and atomizing spray gas flow on ASD critical quality attributes.
• Optimized parameters were validated across diverse drug-polymer combinations, drug loadings, and batch sizes.

Main Results:

• A 5% solid load and 35 mm height atomizing spray gas flow were identified as optimal preset parameters.
• Utilizing these parameters consistently yielded high-quality ASDs with good yields and uniform particle size distribution across varied formulations.
• The strategy demonstrated successful translation into a reproducible and efficient spray-drying platform.

Conclusions:

• Preset spray-drying parameters offer a rapid, material-saving, and efficient approach for early-stage amorphous solid dispersion development.
• This method significantly reduces development timelines and resource requirements, making it ideal for preclinical stages.
• The established parameters provide a robust foundation for developing diverse ASD formulations.