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Bioavailability assessment of a brompheniramine taste-masked pediatric formulation in a juvenile porcine model
Jiang Wang1, Diaa Shakleya1, George Giacoia2
1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation, US Food and Drug Administration, Silver Spring, Maryland, USA.
Insights
A new taste-masked brompheniramine pediatric formulation shows comparable bioavailability to adult versions. This taste-masking approach using tannic acid improves medication compliance for children.
Area of Science:
- Pharmaceutical Sciences
- Pediatric Pharmacology
- Drug Delivery Systems
Background:
- Pediatric patients often exhibit poor compliance with medications due to bitter taste.
- Adult formulations of brompheniramine are known for their unpleasant taste.
- The National Institutes of Health Pediatric Formulation Initiative aims to improve pediatric drug formulations.
Purpose of the Study:
- To develop and evaluate a taste-masked pediatric formulation of brompheniramine.
- To compare the bioavailability of a novel taste-masked brompheniramine formulation against a marketed adult formulation.
- To assess the efficacy of tannic acid for taste-masking brompheniramine.
Main Methods:
- A juvenile porcine model was utilized for preclinical bioavailability assessment.
- Oral administration of both marketed and taste-masked brompheniramine formulations.
- Plasma samples analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) for brompheniramine quantification.
Main Results:
- A validated bioanalytical method demonstrated high accuracy and precision for brompheniramine measurement in plasma.
- Bioavailability profiles of the taste-masked and marketed brompheniramine formulations were not significantly different.
- The taste-masked formulation exhibited comparable pharmacokinetic properties to the adult formulation.
Conclusions:
- Taste-masking brompheniramine with tannic acid is a viable strategy for pediatric formulation development.
- The developed formulation offers a promising alternative to improve medication adherence in pediatric populations.
- This approach supports the development of more palatable and effective pediatric medications.
Abstract:
A brompheniramine taste-masked pediatric formulation was developed as part of the National Institutes of Health Pediatric Formulation Initiative to help address low patient compliance caused by the bitter taste of many adult formulations. To confirm that the taste-masked formulation can provide a similar pharmacological effect to the previous marketed adult formulations, a juvenile porcine model was used to screen the model pediatric formulation to compare the bioavailability between the marketed brompheniramine maleate and the taste-masked maleate/tannate formulation. Pigs were dosed orally with both formulations and blood samples were obtained from 0 to 48 h. Plasma samples were prepared and extracted using solid-phase extraction. The mass spectrometer was operated under selected ion monitoring mode. The selected ion monitoring channels were set to m/z 319.1 for brompheniramine and m/z 275.2 for the internal standard chlorpheniramine. Calibration curves were linear over the analytical range 0.2-20 ng/ml (r2 > 0.995) for brompheniramine in plasma. The intra- and inter-day accuracies were between 98.0 and 105% with 5.73% RSD precision. The bioanalytical method was successfully applied to a preclinical bioavailability study. The bioavailability profiles were not significantly different between the two formulations, which demonstrates that taste-masking with tannic acid is a promising approach for formulation modification for pediatric patients.
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