Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective

Area of Science:

• Pharmaceutical Manufacturing
• Chemical Engineering
• Process Chemistry

Background:

• The pharmaceutical industry is transitioning from traditional batch manufacturing to continuous manufacturing.
• This shift offers enhanced flexibility for diverse populations and improved product quality and efficacy.
• Basic process steps like material feeding become critical in continuous systems.

Purpose of the Study:

• To highlight the fundamental differences between batch dispensing and continuous feeding.
• To explain the impact of these differences on formulation design space.
• To present a rational development approach for continuous manufacturing processes.

Main Methods:

• Reviewing the principles of batch dispensing and continuous feeding.
• Analyzing the effects on formulation design.
• Outlining a standardized approach for material and process characterization.
• Utilizing multidomain simulation tools for predictive modeling.

Main Results:

• Continuous manufacturing necessitates a re-evaluation of fundamental process steps like feeding.
• Understanding the distinct characteristics of dispensing versus feeding is crucial for successful formulation.
• A structured development strategy incorporating characterization and simulation is applicable to continuous unit operations.

Conclusions:

• The transition to continuous manufacturing requires careful consideration of material feeding strategies.
• A rational, data-driven development approach is essential for optimizing continuous pharmaceutical processes.
• Advanced simulation tools aid in predicting and managing process behavior in continuous manufacturing.