Nunn Tony, Williams Julie
Royal Liverpool Children's NHS Trust, Liverpool, UK.
Br J Clin Pharmacol. 2005 Jun;59(6):674-6. doi: 10.1111/j.1365-2125.2005.02410.x.
The development of age-adapted dosage forms and taste-masking of bitter-tasting drugs administered orally for children, are formidable challenges for formulation scientists. Childhood is a period of maturation requiring knowledge of developmental pharmacology to establish dose but the ability of the child to manage different dosage forms and devices also changes. Paediatric formulations must allow accurate administration of the dose to children of widely varying age and weight. Whilst the oral route will be preferred for long term use and the intravenous route for the acutely ill, many of the dosage forms designed for adults, such as oro-dispersible tablets, buccal gels and transdermal patches, would also benefit children if they contained an appropriate paediatric dose. The age at which children can swallow conventional tablets is of great importance for their safety. Liquid medicines are usually recommended for infants and younger children so the ability to mask unpleasant taste with sweeteners and flavours is crucial. More sophisticated formulations such as granules and oro-dispersible tablets may be required but there will be limitations on choice and concentration of excipients. There are many gaps in our knowledge about paediatric formulations and many challenges for the industry if suitable preparations are to be available for all ranges. A CHMP points to consider document is soon to be released. More research and clinical feedback are important because a formulation with poor acceptability may affect compliance, prescribing practice and ultimately commercial viability.
开发适合儿童年龄的剂型以及对口服苦味药物进行掩味,对制剂科学家来说是巨大的挑战。儿童期是一个发育阶段,需要了解发育药理学来确定剂量,但儿童使用不同剂型和给药装置的能力也在变化。儿科制剂必须能让年龄和体重差异很大的儿童准确服用药物。虽然长期用药首选口服途径,急症则首选静脉途径,但许多为成人设计的剂型,如口腔崩解片、口腔凝胶和透皮贴剂,如果含有合适的儿科剂量,对儿童也有益处。儿童能够吞咽常规片剂的年龄对其安全至关重要。通常建议婴儿和年幼儿童服用液体制剂,因此用甜味剂和香料掩盖不良味道的能力至关重要。可能需要更复杂的剂型,如颗粒剂和口腔崩解片,但辅料的选择和浓度会有限制。我们对儿科制剂的了解存在许多空白,如果要为所有年龄段提供合适的制剂,该行业面临诸多挑战。一份欧洲药品管理局人用药品委员会(CHMP)的要点考虑文件即将发布。更多的研究和临床反馈很重要,因为可接受性差的制剂可能会影响依从性、处方习惯,并最终影响商业可行性。