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Related Concept Videos

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Multifractal and mechanical analysis of amorphous solid dispersions.

Camille Adler1, Alexandra Teleki2, Martin Kuentz3

  • 1University of Applied Sciences and Arts Northwestern Switzerland, Institute of Pharmaceutical Technology, Gründenstrasse 40, 4132 Muttenz, Switzerland; University of Basel, Institute of Pharmaceutical Technology, Klingelbergstrasse 50, 4056 Basel, Switzerland.

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Summary

Investigating hot-melt extrudates using multifractal analysis revealed that the carrier type and amorphous beta-carotene (BC) impact microstructure and mechanical properties, crucial for complex pharmaceutical formulations.

Keywords:
Hot-melt extrusionInorganic carrierMechanical propertiesMultifractalScanning electron microscopySolid dispersion

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Formulating lipophilic and hydrophobic compounds presents significant challenges in the pharmaceutical industry, necessitating advanced formulation strategies.
  • The microstructure of extrudates can critically influence the mechanical properties and performance of solid dosage forms.
  • Understanding these relationships is key to developing robust and effective drug delivery systems.

Purpose of the Study:

  • To analyze the microstructural characteristics of hot-melt extrudates using multifractal analysis via scanning electron microscopy (SEM).
  • To investigate the impact of different inorganic carrier types and the presence of amorphous beta-carotene (BC) on the mechanical hardness of extrudates.
  • To establish a comprehensive understanding of complex formulations produced via hot-melt extrusion.

Main Methods:

  • Hot-melt extrusion was employed to produce formulations containing a polymer, lipid, and two distinct silica-based inorganic carriers, with beta-carotene as the model compound.
  • Scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDX) coupled with multifractal formalism was used for microstructural analysis.
  • Mechanical properties were assessed using a three-point bending test to determine extrudate hardness.

Main Results:

  • Multifractal analysis demonstrated that the nature of interparticle interactions within the inorganic carrier significantly influences extrudate microstructure.
  • The presence of amorphous beta-carotene (BC) was found to alter the microstructure and consequently affect the mechanical performance of the extrudates.
  • A correlation was observed between microstructural features, determined by multifractal analysis, and the mechanical properties (hardness) of the extrudates.

Conclusions:

  • Multifractal analysis provides a powerful tool for characterizing the complex microstructures of hot-melt extrudates.
  • The choice of inorganic carrier and the physical state of the active compound (amorphous BC) are critical factors affecting extrudate mechanical properties.
  • Combining multifractal analysis with mechanical testing offers complementary insights for optimizing complex pharmaceutical formulations.