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
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.
引用
收藏
页码:681 / 691
页数:11
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