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

Bioanalysis

Division 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.

Published: September 2024

To improve the palatability and increase compliance in pediatric patients, different taste-masking technologies have been evaluated to support the NIH Pediatric Formulation Initiative. This bioavailability approach combined a juvenile porcine model which represented the pediatric population, and an advanced UHPLCMS/MS method. Juvenile pigs were administered with either commercial Tamiflu or its taste-masking formulation and plasma samples were obtained from 0 to 48 h. The mass spectrometer was operated in positive mode with electrospray ionization. The bioavailability profiles were not significantly different between the two formulations which demonstrated that taste-masking by forming an ionic complex was a promising approach for formulation modification. The pre-clinical study revealed a promising model platform for developing and screening taste-masking formulations.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11389739PMC
http://dx.doi.org/10.1080/17576180.2024.2352256DOI Listing

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