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Related Experiment Video

Updated: Mar 25, 2026

Intravenous Injections in Neonatal Mice
05:17

Intravenous Injections in Neonatal Mice

Published on: November 11, 2014

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Particulate Study on NeoProfen, a Neonatal Injectable Product.

Aravind Krishna1, Michael Rice1, Tom Kester2

  • 1Marathon Pharmaceuticals, Northbrook, IL; and.

PDA Journal of Pharmaceutical Science and Technology
|February 19, 2016
PubMed
Summary

Particulate matter in NeoProfen vials formed from ibuprofen reacting with glass. A new vial coating prevents this interaction, ensuring medication stability for neonatal patients requiring patent ductus arteriosus closure.

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Neonatal Medicine

Background:

  • NeoProfen (ibuprofen lysine) is a critical medication for closing patent ductus arteriosus in premature infants.
  • Particulate matter was observed in NeoProfen vials during stability testing, leading to recalls.
  • Neonatal patients are particularly vulnerable to drug product impurities due to immature organ systems.

Purpose of the Study:

  • To identify the root cause of particulate matter formation in NeoProfen vials.
  • To investigate the interaction between NeoProfen and Type I borosilicate glass.
  • To develop corrective actions to ensure NeoProfen product quality and stability.

Main Methods:

  • Inductively coupled plasma-mass spectrometry (ICP-MS)
  • X-ray photoelectron spectroscopy (XPS)
  • Scanning electron microscopy with energy dispersive X-ray spectrometry (SEM-EDS)
  • Raman and Fourier transform infrared microspectroscopy (FTIR)

Main Results:

  • Particulate matter identified as ibuprofen aluminum salts of varying stoichiometries.
  • Mechanism involves ibuprofen anion reacting with the vial's aluminum oxide network.
  • Formation of ibuprofen aluminum salts occurred over time within the Type I borosilicate glass vials.

Conclusions:

  • The interaction between NeoProfen and Type I borosilicate glass causes particulate formation.
  • An alternate Type I borosilicate glass vial with an interior coating prevents ibuprofen aluminum salt formation.
  • The new vial packaging ensures NeoProfen quality and stability for neonatal use.