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Stability of Pentobarbital Hydrogel for Rectal Administration in Pediatric Procedural Sedation

Sephora Belo1, Justine Touchard1, Philippe-Henri Secretan1,2

  • 1Hôpital Universitaire Necker-Enfants Malades, Paris, France.

Hospital Pharmacy
|August 12, 2021
PubMed

Insights

Rectal pentobarbital gel provides effective sedation for pediatric imaging. This ready-to-use hydrogel formulation is chemically stable for at least 90 days under various storage conditions.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Anesthesiology
  • Radiology

Background:

  • Pentobarbital is a crucial sedative for pediatric imaging procedures like MRI and CT scans.
  • Limited data exists on the stability and formulation of rectal pentobarbital for clinical use.

Purpose of the Study:

  • To formulate and evaluate the stability of a ready-to-use rectal pentobarbital gel.
  • To ensure a reliable and stable sedative option for pediatric patients.

Main Methods:

  • A pentobarbital sodium hydrogel (25 mg/mL) was formulated and packaged in amber glass bottles.
  • Stability was assessed over 90 days at controlled room temperature (22–25°C) and refrigerated conditions (2–8°C).
  • Evaluations included visual inspection, pH measurement, viscosity assessment, and HPLC analysis.

Main Results:

  • The freshly prepared gel was clear, colorless, and free of particulates with a pH of 9.75–9.83.
  • No significant changes in appearance or pH were observed over 90 days.
  • High-performance liquid chromatography confirmed the chemical stability of the formulation at both storage temperatures.

Conclusions:

  • The 25 mg/mL pentobarbital hydrogel is chemically stable for at least 90 days.
  • This stable formulation can be administered to children for effective and rapid sedation during imaging.
  • The study provides essential data supporting the clinical use of rectal pentobarbital gel.

Keywords:
imagingpentobarbitalrectal administrationsedationstability

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