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Placing Growth Factor-Coated Beads on Early Stage Chicken Embryos
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Two Contrasting Failure Modes of Enteric Coated Beads.

Galen H Shi1, Xia Dong2, Michelle Lytle2

  • 1Delivery Device and Connected Systems, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, 46285, USA. galen_shi@lilly.com.

AAPS Pharmscitech
|April 11, 2018
PubMed
Summary

High humidity causes enteric coated bead failure through cracking or agglomeration, impacting drug release. Understanding these distinct failure mechanisms is crucial for pharmaceutical stability.

Keywords:
Coating fractureCoating fusionDMAEnteric coated beadsSEMX-ray CT

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Physical Chemistry

Background:

  • Enteric coatings protect drugs from stomach acid but can fail under storage conditions.
  • Understanding coating failure mechanisms is vital for ensuring drug product stability and efficacy.

Purpose of the Study:

  • To investigate the mechanisms and kinetics of enteric coated bead failure under high humidity and varying temperatures.
  • To identify distinct failure models for enteric coated dosage forms.

Main Methods:

  • Enteric coated beads were exposed to high humidity (75-98% RH) at temperatures ranging from 5-40°C.
  • Analyses included acid dissolution, water activity, Scanning Electron Microscopy (SEM), X-ray Computed Tomography (X-ray CT), and Dynamic Mechanical Analysis (DMA).

Main Results:

  • High humidity exposure led to increased drug release, failing dissolution specifications.
  • SEM revealed cracks at 5°C and agglomeration at 40°C.
  • X-ray CT showed core swelling and crack propagation; DMA indicated reduced glass transition temperature (Tg) of the coating.

Conclusions:

  • Two distinct failure models were identified: core swelling-induced fracture at low temperatures and coating melt flow-induced agglomeration at higher temperatures.
  • These findings provide critical insights into enteric coating stability and degradation pathways.