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Melt milling as manufacturing method for solid crystalline suspensions.

Philip da Igreja1, Annika Erve2, Markus Thommes2

  • 1INVITE GmbH, Chempark Building W32, 51368 Leverkusen, Germany; Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, TU Dortmund University, 44227 Dortmund, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|November 30, 2020
PubMed
Summary

Melt milling successfully produced submicron particles for poorly soluble drugs, enhancing bioavailability. This solid crystalline suspension (SCS) manufacturing method offers improved stability and dissolution compared to traditional nanosuspensions.

Keywords:
Annular gap millMelt millingSolid crystalline suspensionSubmicron particles

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Area of Science:

  • Pharmaceutical technology
  • Materials science
  • Drug delivery

Background:

  • Submicron particle production is crucial for enhancing the bioavailability of poorly water-soluble drugs.
  • Traditional nanosuspensions often face long-term stability challenges.
  • Solid crystalline suspension (SCS) offers a stable alternative by embedding crystalline drugs in a hydrophilic carrier matrix.

Purpose of the Study:

  • To investigate the application of fine grinding in SCS manufacturing.
  • To produce submicron particles (0.1-1 μm) using melt milling.
  • To optimize the melt milling process for improved energy efficiency and reduced thermal drug exposure.

Main Methods:

  • Utilized a custom-built mill with annular gap geometry for fine grinding.
  • Employed differential scanning calorimetry and X-ray powder diffraction to analyze solid-state properties.
  • Conducted dissolution experiments to evaluate the performance of the melt-milled SCS.

Main Results:

  • Successfully produced particles in the submicron range using the custom mill.
  • Optimized grinding process led to improved energy utilization and reduced grinding time.
  • Melt-milled SCS demonstrated superior dissolution performance compared to previous formulations, despite observed agglomerates.

Conclusions:

  • Melt milling is an effective technique for overcoming the low aqueous solubility of drugs.
  • The SCS approach using melt milling provides a stable and effective method for drug formulation.
  • Further research may focus on mitigating agglomeration during solidification.