Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling...

Area of Science:

• Chemical Engineering
• Pharmaceutical Manufacturing
• Process Development

Background:

• Continuous end-to-end pharmaceutical manufacturing requires a final, integrated isolation process for active pharmaceutical ingredients (APIs).
• Existing continuous filtration and washing prototypes are established, but continuous drying remains a challenge.
• Static drying of solvent-wet crystalline APIs in a fixed bed presents issues like particle breakage and lump formation.

Purpose of the Study:

• To develop a continuous drying process for pharmaceutical development.
• To design a continuous filter dryer for pharmaceutical applications.
• To prevent particle breakage and interparticle bridging during API drying.

Main Methods:

• Investigated static drying of solvent-wet crystalline APIs in a fixed bed.
• Developed a drying model to aid process design.
• Evaluated the effects of different washing and drying techniques on particle agglomeration.

Main Results:

• Demonstrated the feasibility of drying small API batches within a time frame suitable for continuous manufacturing.
• Developed a predictive drying model for process design.
• Identified effective washing and drying strategies to minimize particle agglomeration.

Conclusions:

• The developed continuous drying approach is effective for pharmaceutical development.
• The technology's performance is amenable to predictive modeling, facilitating scale-up.
• This work addresses a critical gap in achieving fully continuous pharmaceutical manufacturing.