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A solution for low-dose feeding in continuous pharmaceutical processes.

Stephan Sacher1, Nikolaus Heindl1, Jesús Alberto Afonso Urich1

  • 1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13/2, 8010 Graz, Austria.

International Journal of Pharmaceutics
|October 17, 2020
PubMed
Summary
This summary is machine-generated.

A new micro-feeder accurately dispenses active pharmaceutical ingredients (APIs) at low rates for continuous manufacturing. This technology ensures stable powder feeding, crucial for precise pharmaceutical production.

Keywords:
Continuous feedingHot melt extrusionLow dose APIMicro-feeding

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Drug Delivery Systems

Background:

  • Continuous powder feeding is vital in pharmaceutical manufacturing, demanding accuracy and stability.
  • Accurate dosing of highly potent active pharmaceutical ingredients (APIs) at low feed rates (grams per hour) is challenging for conventional feeders, especially with difficult material properties.

Purpose of the Study:

  • To evaluate a novel micro-feeder's capability for precise and stable powder feeding at low rates.
  • To assess the micro-feeder's integration into a continuous manufacturing line for active pharmaceutical ingredient (API) delivery.

Main Methods:

  • A novel micro-feeder, utilizing active volumetric displacement, was integrated into a hot melt extrusion process.
  • The micro-feeder delivered API at rates as low as one gram per hour.
  • High-performance liquid chromatography (HPLC) was used to analyze the API content in the extruded product.

Main Results:

  • The micro-feeder demonstrated accurate and reproducible powder feeding at low rates.
  • The system proved capable of delivering API at feed rates down to one gram per hour.
  • Successful integration into a continuous manufacturing line was achieved.

Conclusions:

  • The novel micro-feeder system shows high potential for implementation in continuous pharmaceutical manufacturing.
  • Its accuracy and reproducibility at low feed rates address a critical need for handling potent APIs.
  • This technology can enhance the stability and precision of continuous powder feeding processes.