Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, U.P., India.
Crit Rev Ther Drug Carrier Syst. 2020;37(6):553-590. doi: 10.1615/CritRevTherDrugCarrierSyst.2020034405.
The pediatric population is generally considered as "miniature adults," but they actually differ from adults due to their different body compositions and varied stages of organ development, which alter essential biopharmaceutical parameters. The physiological differences between the pediatric population and the adult population alter the essential kinetics and dynamics of the same drug administered at the same dose. For pediatric patients, the drug dose is generally calculated using different formulas based on age, body surface area, or weight, or is simply reduced to half of adult dose. This, however, is not the correct practice. New approaches have emerged for designing customized formulations and medical devices for the pediatric population. Examples of customized formulations are "mini-tablets" and "oro-dispersible films," which attempt to ease the administration of solid oral dosage forms. These specially designed medical devices have shown the ability to overcome many challenges in dose administration to children. One such medical device is the "oral solid dosage pen," which allows for dose adjustment by cutting a tablet-like drug carrier at a predefined height and offers flexibility and convenience for dose administration to the pediatric population. Other medical devices, such as the Nipple Shield Delivery System (NSDS) and Medibottle also aid in efficient drug delivery to pediatrics. This review summarizes the challenges in dosage form design and advances in suitable medical devices for better administration to the pediatric population to overcome accidents due to medical errors, incomplete absorption, and toxicity.
儿科人群通常被认为是“小大人”，但由于其身体成分不同和器官发育阶段的不同，他们实际上与成年人不同，这会改变基本的生物制药参数。儿科人群和成年人之间的生理差异改变了相同药物在相同剂量下的基本动力学和动态学。对于儿科患者，药物剂量通常根据年龄、体表面积或体重使用不同的公式计算，或者简单地减少到成人剂量的一半。然而，这并不是正确的做法。已经出现了为儿科人群设计定制配方和医疗器械的新方法。定制配方的例子是“迷你片剂”和“口腔速溶膜”，它们试图简化固体口服剂型的给药。这些专门设计的医疗器械已经显示出克服儿童给药剂量方面许多挑战的能力。一种这样的医疗器械是“口服固体制剂笔”，它允许通过切割药物载体到预定高度来调整剂量，并为儿科人群的给药提供灵活性和便利性。其他医疗器械，如奶嘴盾给药系统（NSDS）和 Medibottle 也有助于向儿科人群高效地输送药物。这篇综述总结了在剂型设计和适合儿科人群给药的医疗器械方面的挑战和进展，以克服因医疗失误、吸收不完全和毒性而导致的事故。
