Enhancing Patient-Centric Drug Development: Coupling Hot Melt Extrusion with Fused Deposition Modeling and...

Area of Science:

• Pharmaceutical Manufacturing
• Materials Science
• Drug Delivery Systems

Background:

• Traditional pharmaceutical manufacturing struggles to meet the growing demand for complex, patient-centric medications.
• Existing methods like direct blending and granulation are inadequate for personalized dosing, combinations, and release profiles.
• The "one size fits all" approach in medicine is increasingly being replaced by a need for tailored treatments.

Purpose of the Study:

• To review advancements in additive manufacturing for creating patient-centric medications.
• To explore nozzle-based additive manufacturing techniques, specifically pressure-assisted microsyringe (PAM) and fused deposition modeling (FDM).
• To discuss the integration of these techniques with hot melt extrusion (HME) for continuous manufacturing and quality control.

Main Methods:

• Review of literature on nozzle-based additive manufacturing (PAM, FDM) for pharmaceutical applications.
• Discussion of thermal energy application in these processes and PAM's ambient condition capability.
• Exploration of pairing nozzle-based techniques with hot melt extrusion (HME) for continuous manufacturing.

Main Results:

• Nozzle-based additive manufacturing platforms (PAM, FDM) show significant potential for developing complex and on-demand medications.
• These techniques can be integrated with hot melt extrusion (HME) and process analytical technology (PAT) for continuous manufacturing.
• Critical parameters influencing product quality, continuous manufacturing, quality by design (QbD), and future perspectives are discussed.

Conclusions:

• Additive manufacturing, particularly nozzle-based methods, is crucial for advancing patient-centric pharmaceutical development.
• Integration with HME and PAT enables robust continuous manufacturing processes for safe and effective medications.
• Further research into critical parameters and QbD is essential for realizing the full potential of these technologies.