Statistical modeling, optimization and characterization of spray-dried solid self-microemulsifying drug delivery...

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Solid self-microemulsifying drug delivery systems (SMEDDS) offer improved drug solubility and bioavailability.
• Optimizing spray-drying parameters is crucial for achieving desired solid-SMEDDS characteristics.

Purpose of the Study:

• To systematically investigate and optimize spray-drying process variables for solid-SMEDDS production.
• To achieve specific powder quality attributes including moisture content, yield, drug content, and droplet size.

Main Methods:

• Utilized a three-factor, three-level Box-Behnken design (DOE) to study inlet temperature, feed rate, and carrier concentration.
• Evaluated responses such as moisture content, yield, drug content, and droplet size.
• Assessed powder characteristics including morphology, thermal behavior, crystallinity, and flowability.

Main Results:

• Developed predictive models for responses, indicating good predictability.
• Identified significant effects of processing parameters on powder characteristics.
• Optimized parameters (134°C inlet temperature, 5% feed rate, 0.6% carrier concentration) yielded acceptable moisture content, yield, drug content, and droplet size.
• Achieved amorphous form of flurbiprofen from a crystalline state.

Conclusions:

• Demonstrated the successful application of DOE for optimizing solid-SMEDDS manufacturing.
• Validated the reproducibility of the developed models through batch production.
• Solid-SMEDDS produced with optimized parameters exhibited desired quality attributes and enhanced drug properties.