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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Sonocrystallization yields monoclinic paracetamol with significantly improved compaction behavior.

Dejan-Krešimir Bučar1, James A Elliott, Mark D Eddleston

  • 1Department of Chemistry, University College London, 20 Gordon Street, London WC1H 0AJ (UK). d.bucar@ucl.ac.uk.

Angewandte Chemie (International Ed. in English)
|November 6, 2014
PubMed
Summary

Ultrasound-assisted crystallization produced nano- and micrometer-sized paracetamol crystals. These crystals significantly enhance tabletability, overcoming poor mechanical properties without additives.

Keywords:
crystal growthnanostructurespolymorphismpowder compactionsonocrystallization

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Crystallization Engineering

Background:

  • Paracetamol, a common analgesic, exhibits poor tabletability due to unfavorable mechanical properties.
  • Current methods to improve paracetamol tabletability often involve excipients, coatings, or complex salt/cocrystal formation.

Purpose of the Study:

  • To enhance the tabletability of monoclinic paracetamol.
  • To investigate the effect of crystal size on paracetamol's mechanical behavior.
  • To achieve improved compaction without resorting to additives.

Main Methods:

  • Ultrasound-assisted crystallization (sonocrystallization) to produce nano- and micrometer-sized paracetamol crystals.
  • Characterization of crystal size distribution.
  • Experimental compaction studies.
  • Finite element analysis (FEA) to model mechanical behavior.

Main Results:

  • Sonocrystallization yielded a mixture of nano- and micrometer-sized paracetamol crystals.
  • The resulting powder demonstrated significantly higher elastic moduli and bulk cohesions compared to macrometer-sized crystals.
  • Enhanced tabletability was achieved without the use of excipients, particle coating, salt, or cocrystal formation.

Conclusions:

  • Crystal size engineering via sonocrystallization is an effective strategy to improve paracetamol's mechanical properties.
  • The improved compaction behavior is attributed to the increased elastic moduli and bulk cohesions of smaller crystals.
  • This approach offers a novel, additive-free method for enhancing the tabletability of poorly performing pharmaceutical materials.