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Study of quality and stability of ursodeoxycholic acid formulations for oral pediatric administration

A Santoveña1, E Sánchez-Negrín1, L Charola1

  • 1Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de La Laguna, 38200 La Laguna, Tenerife, Spain.

International Journal of Pharmaceutics
|October 12, 2014
PubMed

Insights

This study developed a method to test pediatric ursodeoxycholic acid (UDCA) oral suspensions. UDCA proved stable, but glycerol is needed for accurate dosing, and refrigeration increases dose variability.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Pediatric Pharmacology

Background:

  • Ursodeoxycholic acid (UDCA) is crucial for pediatric cholestatic liver diseases.
  • No suitable commercial UDCA formulations exist for infants and children, necessitating API development.
  • Low solubility and dose (1.5%) of UDCA present formulation challenges.

Purpose of the Study:

  • To develop and validate a rational method for characterizing the biopharmaceutical stability and dose uniformity of pediatric UDCA oral suspensions.
  • To assess the impact of storage conditions and formulation components on UDCA suspension quality.
  • To ensure accurate and reliable dosing for pediatric patients.

Main Methods:

  • Preparation of two UDCA oral suspensions using minimal, EMA-recommended excipients.
  • Characterization of particle size, stability, and rheological properties following Standard Operating Procedures (SOPs).
  • Determination of dose uniformity (mass and content variability) according to European and United States Pharmacopoeia criteria, assessing variations over 30 and 60 days under different storage conditions.

Main Results:

  • UDCA suspensions demonstrated acceptable particle size and rheological behavior post-stirring.
  • UDCA was found to be stable under all tested conditions.
  • Glycerol inclusion was essential for achieving the declared API content after stirring; refrigeration increased dose variability.

Conclusions:

  • A validated method for assessing UDCA suspension dose uniformity and stability in pediatrics was established.
  • Formulation requires glycerol to ensure accurate dosing, highlighting its critical role.
  • Refrigerated storage negatively impacts dose consistency, advising against it for these suspensions.

Keywords:
Dose uniformityPediatric administrationStabilityStandard Operating ProcedureUrsodeoxycholic acid oral suspension

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