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.
Obstetric and Pediatric Pharmacology and Therapeutics Branch, National Institute of Child Health and Human Development, National Institutes of Health. Rockville Pike, Bethesda, MD 9000, USA.
Bioanalysis. 2024;16(13):681-691. doi: 10.1080/17576180.2024.2352256. Epub 2024 Jun 11.
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.
为了提高儿科患者的适口性并增加顺应性，已经评估了不同的掩味技术以支持 NIH 儿科配方倡议。这种生物利用度方法结合了一个代表儿科人群的幼年猪模型，以及一种先进的 UHPLCMS/MS 方法。给幼年猪施用市售的达菲或其掩味制剂，并在 0 至 48 小时内从血浆中取样。质谱仪在正模式下以电喷雾电离操作。两种制剂的生物利用度曲线没有显著差异，这表明通过形成离子复合物来掩味是一种有前途的制剂修饰方法。临床前研究揭示了一种有前途的模型平台，用于开发和筛选掩味制剂。
