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Membrane-Based Solvent Exchange Process for Purification of API Crystal Suspensions.

Fatima Anjum1, Maximilian Wessner1, Gabriele Sadowski1

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Membranes
|March 29, 2023
PubMed
Summary

Membrane diafiltration effectively removes ethanol from active pharmaceutical ingredient (API) crystal suspensions, meeting strict residual solvent limits. This bottom-up approach maintains crystal stability, crucial for pharmaceutical manufacturing.

Keywords:
diafiltrationlong acting injectablesorganic solvent nanofiltrationpharmaceutical crystal suspensions

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Bottom-up production of active pharmaceutical ingredient (API) crystal suspensions, like anti-solvent crystallization, offers superior control over particle properties.
  • A critical challenge in API crystallization is the removal of organic solvents to meet stringent regulatory limits for human safety.

Purpose of the Study:

  • To investigate the efficacy of membrane-based diafiltration for removing organic solvents from API crystal suspensions.
  • To establish a proof of concept for a scalable solvent removal process in API production.

Main Methods:

  • A four-stage membrane diafiltration process was employed to remove ethanol from a naproxen crystal suspension.
  • Ethanol concentration was monitored to ensure compliance with International Council for Harmonisation (ICH) guidelines.

Main Results:

  • The diafiltration process successfully reduced ethanol concentration below the 0.5 wt% ICH residual solvent limit.
  • The process achieved this reduction with a water consumption of 1.5 g water per g of feed.
  • No adverse effects on crystal stability, including size and polymorphic form, were observed.

Conclusions:

  • Membrane diafiltration is a viable and effective method for removing organic solvents from API crystal suspensions.
  • This technique supports the development of bottom-up manufacturing processes for APIs, ensuring product safety and quality.