Institute of Pharmaceutics and Biopharmaceutics, Pharmacy Department, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Expert Opin Drug Deliv. 2021 Dec;18(12):1873-1890. doi: 10.1080/17425247.2021.2011856. Epub 2021 Dec 3.
Child appropriate dosage forms are indispensable in modern medicine and are a prerequisite for successful pediatric drug therapy. For years, experts have called for a paradigm shift, from liquid dosage forms to novel oral solid dosage forms. This review aims to shed light on recent developments in Orodispersible tablets (ODTs) and mini-tablets (ODMTs).
This review focuses on the presentation and critical discussion of current challenges as well as recent advances in ODTs for pediatric drug delivery. Highlighted aspects are the evidence for acceptability by children, e.g. in comparison to other dosage forms, and limitations given by tablet size at different ages, as well as advances in special ODT formulations (taste masking, modified release, enabling formulations).
It is the authors' belief that OD(M)Ts have significant potential as dosage forms in pediatric therapy that has not yet been fully exploited. The reasons for this are, first, that the number of direct acceptance studies is extremely low and the resulting knowledge is therefore rather anecdotal. Despite the high relevance, there seems to be reluctance both in the therapeutic use and conduction of respective studies in children. However, if one combines the knowledge from the few existing studies, surveys, and from approved products, it becomes apparent that so far there is no evidence on limitations of the use of ODTs in pediatric patients.
儿童适用剂型在现代医学中不可或缺，是成功开展儿科药物治疗的前提。多年来，专家们一直呼吁从液体制剂向新型口服固体制剂转变。本文旨在介绍口溶片（ODTs）和迷你片剂（ODMTs）的最新进展。
本文重点介绍了儿科药物传递用 ODT 目前面临的挑战及最新进展，并对其进行了介绍和批判性讨论。突出的方面是儿童对 ODT 的可接受性证据，例如与其他剂型相比，以及不同年龄段片剂大小带来的限制，以及特殊 ODT 制剂（掩味、控释、赋形剂）的进展。
作者认为，OD（M）Ts 作为儿科治疗的剂型具有很大的潜力，但尚未得到充分利用。原因之一是直接接受研究的数量极低，因此相关知识相当零散。尽管相关性很高，但在儿童治疗中，人们似乎既不愿意使用，也不愿意开展相关研究。然而，如果将少数现有研究、调查和已批准产品的知识结合起来，就会发现目前没有证据表明 ODT 在儿科患者中的使用受限。
