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Related Experiment Videos

Endotoxin testing in inhalation grade lactose-a useful quality parameter?

Hartwig Steckel1, Franz H Furkert

  • 1Department of Pharmaceutics and Biopharmaceutics, Christian Albrecht University Kiel, Gutenbergstrasse 76, 24118 Kiel, Germany. steckel@pharmazie.uni-kiel.de

International Journal of Pharmaceutics
|April 15, 2004
PubMed
Summary

Alpha-lactose monohydrate, a common inhalation drug carrier, shows low endotoxin levels. This study found endotoxin content well below limits, ensuring safety for dry powder inhalation products.

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Area of Science:

  • Pharmaceutical Sciences
  • Microbiology
  • Drug Delivery

Background:

  • Alpha-lactose monohydrate is a critical excipient in dry powder inhalation (DPI) formulations.
  • Ensuring the quality of DPIs requires careful control of physico-chemical and microbiological properties.
  • Endotoxin contamination is a key microbiological parameter for inhaled products.

Purpose of the Study:

  • To determine the endotoxin content in multiple batches of alpha-lactose monohydrate from different manufacturers.
  • To assess the safety of using alpha-lactose monohydrate in DPIs concerning endotoxin exposure.
  • To compare endotoxin exposure from DPIs with established air quality guidelines.

Main Methods:

  • Semi-quantitative Limulus Amebocyte Lysate (LAL) assay was used for endotoxin determination.

Related Experiment Videos

  • Nineteen batches of alpha-lactose monohydrate from two suppliers were tested.
  • Calculations were performed to estimate daily endotoxin exposure from DPI use.

    • Main Results:

    • All tested batches of alpha-lactose monohydrate contained less than 18 endotoxin units (EU)/g.
    • Most batches exhibited endotoxin levels below 3 EU/g.
    • Estimated daily endotoxin exposure from DPI use is significantly lower (two log steps) than recommended limits for inhaled air.

    Conclusions:

    • Alpha-lactose monohydrate generally possesses low endotoxin levels, suitable for DPI applications.
    • The endotoxin exposure from typical DPI usage is well within safe limits.
    • Routine monitoring of endotoxin in lactose excipients is essential for DPI product quality and patient safety.