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Published on: September 25, 2016
Methodology for rapid development of a continuous loss-in-weight feeding process
Ana Martins1, Cláudia Moura2, João Henriques2
1Oral Drug Product Development, Hovione FarmaCiencia SA, Estrada do Paço do Lumiar, Campus do Lumiar, Edifício S, 1649-038 Lisboa, Portugal; Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-033 Lisboa, Portugal.
Continuous tableting offers advantages over batch processing. This study links material properties and feeder setup to predict feeding performance, accelerating pharmaceutical manufacturing development.
Area of Science:
- Pharmaceutical Manufacturing
- Chemical Engineering
- Materials Science
Background:
- Continuous manufacturing is increasingly adopted in the pharmaceutical industry for tablet production.
- Continuous tableting offers benefits such as higher efficiency, better control, smaller footprint, and consistent quality compared to batch processing.
- Accurate control of continuous processes relies on understanding mass flow variability and feed factor profiles in loss-in-weight feeding.
Purpose of the Study:
- To bridge the gap between raw material properties and feeder output in continuous manufacturing.
- To investigate the impact of feeder setup options on feeding performance.
- To expedite the process development stage for continuous tableting.
Main Methods:
- Characterization of nineteen diverse pharmaceutical materials (excipients, APIs) for physical and rheological properties.
- Conducting volumetric feeding trials using a loss-in-weight feeder to assess feeding performance (mass flow RSD, feed factor profile).
- Utilizing Partial Least Squares regression to correlate material properties with feeder performance and conducting experiments to evaluate feeder setup impacts.
Main Results:
- Feeder performance was successfully estimated using material properties like density, flowability, cohesion, charge density, and porosity.
- A data-driven workflow was developed to define feeder setup and operating ranges, demonstrating accuracy across five different materials.
- The workflow accurately predicted feeder setup parameters compared to experimental results.
Conclusions:
- A data-driven approach effectively predicts loss-in-weight feeder performance based on material characteristics and setup.
- The developed workflow accelerates the definition of feeder setup, reducing material and time requirements.
- This methodology enhances the efficiency of continuous manufacturing process development in the pharmaceutical industry.
