[Optimize dropping process of Ginkgo biloba dropping pills by using design space approach]

Area of Science:

• Pharmaceutical Technology
• Process Engineering
• Herbal Medicine Manufacturing

Background:

• Optimizing the manufacturing process for herbal medicinal products like Ginkgo biloba dropping pills is crucial for consistent quality.
• Traditional methods may lack the precision needed for reproducible pharmaceutical production.

Purpose of the Study:

• To apply a design space approach to optimize the dropping process of Ginkgo biloba dropping pills.
• To identify critical process parameters (CPPs) and critical quality attributes (CQAs) for efficient production.

Main Methods:

• Literature research and pre-experiments to identify potential CPPs and CQAs.
• Box-Behnken design experiments to determine CPPs and CQAs.
• Development of second-order polynomial models to establish relationships between CPPs and CQAs.
• Calculation and verification of a probability-based design space.

Main Results:

• Critical process parameters and quality attributes were identified through experimental analysis.
• Second-order polynomial models quantitatively described the relationships between CPPs and CQAs.
• A verified design space ensures efficient production of Ginkgo biloba dropping pills.
• Recommended ranges: dropping distance (5.5–6.7 cm) and dropping speed (59–60 drops/min).

Conclusions:

• The design space approach effectively optimizes the Ginkgo biloba dropping pill manufacturing process.
• Operating within the defined design space guarantees efficient and reproducible production.
• The study provides valuable operational parameters for the industrial-scale manufacturing of Ginkgo biloba dropping pills.