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Complex Structures Made Simple - Continuous Flow Production of Core Cross-Linked Polymeric Micelles for Paclitaxel

Tobias A Bauer1, Jonas Schramm2, Federico Fenaroli3

  • 1Leiden Academic Centre for Drug Research (LACDR), Leiden University, Einsteinweg 55, Leiden, 2333CC, The Netherlands.

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Summary

This study introduces a continuous flow process for manufacturing core cross-linked polymeric micelles (CCPMs), enabling efficient, large-scale synthesis of drug carriers. The novel method produces redox-responsive CCPMs with pH-dependent drug release and improved safety profiles.

Keywords:
cross-linkingmicrofluidicsnanomedicinepolymeric micellespolypept(o)ides

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Area of Science:

  • Nanomaterials Science
  • Polymer Chemistry
  • Chemical Engineering

Background:

  • Translating nanomaterials into medical products necessitates scalable and reproducible manufacturing.
  • Multifunctional drug carriers are crucial for advanced medical applications.
  • Current methods often involve multiple separate steps for synthesis and purification.

Purpose of the Study:

  • To develop a continuous flow process for synthesizing pro-drug-loaded core cross-linked polymeric micelles (CCPMs).
  • To integrate micelle formation, cross-linking, functionalization, and purification into a single, efficient process.
  • To create redox-responsive CCPMs for pH-dependent drug delivery with enhanced safety and efficacy.

Main Methods:

  • Continuous flow microfluidic synthesis of CCPMs using polysarcosine-block-poly(S-ethylsulfonyl-l-cysteine) and dihydrolipoic acid hydrazide cross-linkers.
  • Slit interdigital micromixers for self-assembly and cross-linking.
  • Online tangential flow filtration for purification.
  • Paclitaxel loading and characterization of drug release profiles.
  • In vivo efficacy testing in a zebrafish model.

Main Results:

  • Spherical CCPMs (Dh = 35 nm) with low polydispersity (PDI < 0.1) were produced at rates of 350-700 mg/h.
  • The process avoided toxic organic solvents and achieved high purity (unimer ≤ 0.5%).
  • Paclitaxel-loaded CCPMs demonstrated pH-responsive release, stable encapsulation, reduced toxicity compared to Abraxane, and therapeutic efficacy in vivo.

Conclusions:

  • A single, continuous flow process enables efficient, scalable, and reproducible synthesis of functional CCPMs.
  • This microfluidic approach offers a promising platform for developing advanced, safer drug delivery systems.
  • The developed CCPMs show significant potential for therapeutic applications, particularly in cancer treatment.