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Evaluation of the bioavailability of a Tamiflu taste-masking pediatric formulation using a juvenile pig model and

Jiang Wang1, Jianghong Gu1, Patrick J Faustino1

  • 1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation, US Food and Drug Administration. New Hampshire Avenue, Silver Spring, MD 10903, USA.

Bioanalysis
|September 10, 2024
PubMed

Insights

Taste-masking formulations of Tamiflu showed comparable bioavailability to the commercial version in a pediatric pig model. This indicates taste-masking ionic complex technology is a viable strategy for improving pediatric drug compliance.

Area of Science:

  • Pharmacokinetics
  • Drug Formulation
  • Pediatric Pharmacology

Background:

  • Improving medication adherence in children is crucial for effective treatment.
  • Taste-masking technologies are essential for enhancing palatability in pediatric formulations.
  • The NIH Pediatric Formulation Initiative supports the development of better pediatric drug delivery systems.

Purpose of the Study:

  • To evaluate the bioavailability of a taste-masked formulation of Tamiflu compared to the commercial version.
  • To assess the efficacy of taste-masking technology in improving pediatric drug compliance.
  • To validate a juvenile porcine model for pediatric drug formulation studies.

Main Methods:

  • A juvenile porcine model was utilized to simulate pediatric pharmacokinetics.
  • Ultra-High-Performance Liquid Chromatography-Tandem Mass Spectrometry (UHPLC-MS/MS) was employed for drug quantification.
  • Plasma samples were collected over 48 hours post-administration of Tamiflu formulations.

Main Results:

  • No significant difference in bioavailability was observed between the taste-masked and commercial Tamiflu formulations.
  • Taste-masking via ionic complex formation proved to be a successful formulation modification strategy.
  • The study demonstrated the potential of taste-masking to improve pediatric patient compliance.

Conclusions:

  • The juvenile porcine model serves as a promising platform for pre-clinical evaluation of pediatric drug formulations.
  • Ionic complexation is an effective method for developing palatable and bioavailable pediatric medications.
  • This research supports the development of improved taste-masked antiviral formulations for children.

Keywords:
UHPLC-MS/MSbioavailabilityoseltamivirpediatrictaste-masking formulation

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