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Evaluation of the bioavailability of a Tamiflu taste-masking pediatric formulation using a juvenile pig model and LC-MS/MS
被引:0
|作者:
Wang, Jiang
[1
]
Gu, Jianghong
[1
]
Faustino, Patrick J.
[1
]
Siddiqui, Akhtar
[1
]
Zhao, Yang
[1
]
Giacoia, George
[2
]
Shakleya, Diaa
[1
]
机构:
[1] US FDA, Ctr Drug Evaluat & Res, Div Prod Qual Res, Off Testing & Res,Off Pharmaceut Qual, New Hampshire Ave, Silver Spring, MD 20903 USA
[2] Natl Inst Child Hlth & Human Dev, Obstet & Pediat Pharmacol & Therapeut Branch, NIH, Rockville Pike, Bethesda, MD USA
来源:
关键词:
bioavailability;
oseltamivir;
pediatric;
taste-masking formulation;
UHPLC-MS/MS;
PERFORMANCE LIQUID-CHROMATOGRAPHY;
RP-HPLC METHOD;
OSELTAMIVIR CARBOXYLATE;
ANTIVIRAL DRUGS;
PLASMA;
VALIDATION;
METABOLITE;
PHOSPHATE;
ASSAY;
TECHNOLOGIES;
D O I:
10.1080/17576180.2024.2352256
中图分类号:
Q5 [生物化学];
学科分类号:
071010 ;
081704 ;
摘要:
Aim: To improve the palatability and increase compliance in pediatric patients, different taste-masking technologies have been evaluated to support the NIH Pediatric Formulation Initiative. Methods: 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. Results: 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. Conclusion: The pre-clinical study revealed a promising model platform for developing and screening taste-masking formulations.
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页码:681 / 691
页数:11
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