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Automated process development with pure API filling using vacuum drum.

Isabel Gallego1, Thomas Brinz2, Martin Sommerfeld3

  • 1Syntegon Technology GmbH, Stuttgarter Str. 130, 71332 Waiblingen, Germany; Multiphase Flow Systems (MPS), Institute Process Engineering, Otto-von-Guericke-University, Universitätsplatz 2, 39106 Magdeburg, Germany.

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|May 5, 2025
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Summary

Automated Process Development (APD) optimized pure active pharmaceutical ingredient (API) filling using vacuum drum fillers. Powder preparation parameters, especially the 3-wire stirrer, significantly improved capsule filling accuracy and reduced variability.

Keywords:
Automated process developmentCapsule fillingDesign of experimentsParacetamolPure APIVacuum drum

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Drug Development

Background:

  • Dosing pure active pharmaceutical ingredients (APIs) is crucial for efficiency in pharmaceutical development, reducing consumption and development time.
  • Vacuum drum fillers are precise instruments for micro-dosing, commonly used in dry powder inhalation (DPI) but their suitability for pure API filling requires investigation.
  • Automated Process Development (APD) combines design of experiments (DoE) with automated execution for efficient process optimization.

Purpose of the Study:

  • To evaluate the suitability of vacuum drum fillers for pure API capsule filling.
  • To analyze the impact of various process parameters on filling weight and relative standard deviation (RSD) using the APD method.
  • To identify key parameters for optimizing pure API filling processes.

Main Methods:

  • Investigated pure API filling using a vacuum drum filler system.
  • Employed the Automated Process Development (APD) method, integrating design of experiments (DoE).
  • Tested two forms of paracetamol: powdered and micronized, assessing filling weight and RSD.

Main Results:

  • Process parameters related to powder preparation in the chamber, not vacuum or pressure, had the most significant impact on filling accuracy.
  • The 3-wire stirrer consistently improved filling weights and reduced RSD for both powdered and micronized paracetamol.
  • APD successfully identified parameters minimizing RSD for powdered paracetamol, highlighting the need for tailored optimization.

Conclusions:

  • The APD method is effective in optimizing vacuum drum filling of pure APIs.
  • Powder preparation parameters, particularly the use of a 3-wire stirrer, are critical for achieving precise and consistent capsule filling.
  • Further research is required to optimize powder preparation for micronized paracetamol to achieve consistent filling.