儿童用多颗粒剂型

María Esther Martínez-Terán, Thanh Huong Hoang-Thi, M. Flament
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引用次数: 9

摘要

近年来,关于儿科药物的法规引起了对研究新的适合儿童的剂型的需求增加。事实上,儿童不能被认为是“小大人”,因为他们表现出不同的解剖和生理特征。无论采用何种给药途径,配方的年龄适宜性是非常重要的,必须加以考虑。新的儿科剂型的开发遇到了技术上的复杂性,如剂量调整、易于给药/吞咽、掩味、化学和物理稳定性、保存、多相和/或多用途产品的考虑、包装、提供/设计测量装置。创新很重要,研究给药的新方法往往会改善依从性、便利性和药代动力学。最近,世界人类组织建议,小型固体形式或口腔分解固体形式应该得到青睐。固体多颗粒系统,如颗粒,具有覆盖不同患者的大剂量范围的优势。剂量调整可以通过诸如多颗粒计数装置的加药装置精确地完成。开发具有快速崩解的多颗粒剂型对儿童是有用的,因为它们同时具有固体和液体制剂的优点。这导致了口腔崩解片的概念,它在口腔中迅速分解成小颗粒或颗粒。它们的小体积使它们沿胃肠道分布良好,提高了生物利用度,同时降低了局部药物浓度,毒性和副作用的风险。它们为儿科患者和护理人员提供易于吞咽和剂量灵活性。我们在多颗粒剂型中使用的快速崩解颗粒的有希望的结果表明,它们可能是儿科药物坚实平台技术的基础。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Multi-Particulate Dosage Forms for Pediatric Use
In recent years, regulations on pediatric medicines have induced an increased need for research into novel childappropriate dosage forms. Indeed, children cannot be considered as « small adults » as they present different anatomical and physiological characteristics. Whatever the route of administration, the age-appropriateness of the formulation is of major importance and has to be taken into consideration. The development of new pediatric dosage forms encounters technical complexities such as dose modification, ease of administration/swallowing, tastemasking, chemical and physical stability, preservation, considerations of a multi-phase and/or multi-use product, packing, providing/designing the measuring device. Innovations are important and the research of new ways to deliver medicines tends to improve compliance, convenience and pharmacokinetic. Recently, the World Human Organization recommended that small sized solid forms or orally disintegrating solid forms should be favored. Solid multi-particulate systems such as pellets have the advantage to cover a broad range of doses for different patients. Dose adjustment can be accurately done by means of dosing device such as a multi-particulate counting device. Developing multi-particulate dosage form with fast disintegration can be useful for children as they present both advantages of solid and liquid formulations. This led to the concept of Orally Disintegrating Tablet which disintegrates rapidly in the mouth into small particles or pellets. Their small size enables them to be well distributed along the gastrointestinal tract improving the bioavailability while reducing local drug concentration, risk of toxicity and side effects. They offer easy swallowing and dose flexibility for pediatric patients and caregivers. The promising results of our fast disintegrating pellets used in multi-particulate dosage forms indicate that they might be the base of a solid platform technology for pediatric medicines.
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