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Related Experiment Video

Updated: May 10, 2025

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Deconstructing Annealing Phenomena in Modified Release Lipid Multiparticulates.

Kellyn M Patros Zagaja1, Michael C Roy1, Kavan Jakuba1

  • 1Pfizer Research and Development, Pfizer Inc., Groton, Connecticut 06340, United States.

Molecular Pharmaceutics
|April 24, 2025
PubMed
Summary
This summary is machine-generated.

Annealing modified release lipid multiparticulates, made of glyceryl behenate and poloxamer 407, refines crystals and separates phases. This process is crucial for achieving stable drug dissolution profiles.

Keywords:
annealingglyceryl behenatelipid polymorphismmicrospheremultiparticulatepoloxamer 407

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Modified release drug delivery systems are crucial for therapeutic efficacy.
  • Lipid multiparticulates offer a versatile platform for controlled drug release.
  • Understanding excipient behavior during manufacturing is key to product performance.

Purpose of the Study:

  • To investigate the impact of annealing on glyceryl behenate and poloxamer 407 lipid multiparticulates.
  • To elucidate the mechanisms driving changes in dissolution profiles post-annealing.
  • To establish a link between material properties and drug release kinetics.

Main Methods:

  • Synthesis and annealing of lipid multiparticulates using glyceryl behenate and poloxamer 407.
  • Characterization using powder X-ray diffraction, scanning electron microscopy, quantitative 1H NMR, and Raman spectroscopy.
  • Analysis of dissolution profiles using novel flow-NMR techniques and nonlinear mixed effects modeling.

Main Results:

  • Annealing induced glyceryl behenate crystal refinement and poloxamer 407 phase separation.
  • These microstructural changes directly correlated with altered drug dissolution rates.
  • Kinetically stable dissolution profiles were achieved after optimized annealing.

Conclusions:

  • Annealing is a critical step for controlling the microstructure of glyceryl behenate-poloxamer 407 multiparticulates.
  • Crystal refinement and phase separation are the primary mechanisms governing dissolution changes.
  • This study highlights the importance of thermal processing for achieving desired modified-release characteristics.