Wagner-Hattler Leonie, Kiene Klara, Bielicki Julia, Pfister Marc, Puchkov Maxim, Huwyler Jörg
Department of Pharmaceutical Sciences, Division of Pharmaceutical Technology, University of Basel, 4056 Basel, Switzerland.
Pediatric Pharmacology and Pharmacometrics, University Children's Hospital (UKBB), University Hospital Basel, 4056 Basel, Switzerland.
Children (Basel). 2021 Mar 5;8(3):194. doi: 10.3390/children8030194.
There is a high unmet medical need for child-appropriate oral dosage forms. The acceptability of a novel placebo orally dispersible tablet formulation (pODT) was therefore evaluated. Monolithic tablets contain an inorganic calcium carbonate/calcium phosphate carrier material as the main excipient. They were assessed in a cross-sectional acceptability study. The 40 child participants were between 2 to 5 years and 6 to 10 years old. One pODT with 5 mm diameter was administered to each participating child by placement on the tongue or into the buccal cavity. Parents were asked to complete a questionnaire together with the study personnel. The spontaneous reactions of the children were recorded. The ease of administration and children's acceptance of the tablet was rated by research staff on a 4-point acceptability scale and by parents on a 5-point Likert scale. The older subjects answered how they had liked the pODT by pointing to the appropriate face of a Facial Hedonic Scale. pODT had very high acceptability as 93% of parents, and all questioned children reported the formulation to be acceptable or very acceptable. Staff reported administering pODT in these children without problems. None of the children showed distress on receipt of pODT. We conclude that the proposed child-friendly dosage form provides a convenient option for oral drug administration and is expected to enhance drug-adherence in pediatric patients.
对于适合儿童的口服剂型存在很高的未满足医疗需求。因此，对一种新型安慰剂口腔崩解片制剂（pODT）的可接受性进行了评估。整体片含有无机碳酸钙/磷酸钙载体材料作为主要辅料。在一项横断面可接受性研究中对其进行了评估。40名儿童参与者年龄在2至5岁和6至10岁之间。通过将一片直径为5毫米的pODT放置在舌头上或口腔颊部，给每位参与研究的儿童服用。要求家长与研究人员一起完成一份问卷。记录儿童的自发反应。研究人员根据4分可接受性量表、家长根据5点李克特量表对片剂的给药便利性和儿童接受程度进行评分。年龄较大的受试者通过指向面部享乐量表上合适的表情来回答他们对pODT的喜爱程度。pODT具有很高的可接受性，因为93%的家长以及所有接受询问的儿童都报告该制剂是可接受的或非常可接受的。工作人员报告在这些儿童中给予pODT没有问题。没有一名儿童在接受pODT时表现出痛苦。我们得出结论，所提议的适合儿童的剂型为口服给药提供了一种方便的选择，并有望提高儿科患者的药物依从性。
