Preis Maren
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University of Düsseldorf, Building 26.22, Universitaetsstrasse 1, 40225, Duesseldorf, Germany,
AAPS PharmSciTech. 2015 Apr;16(2):234-41. doi: 10.1208/s12249-015-0313-1. Epub 2015 Mar 5.
Oral drug delivery is a non-invasive and therefore a very convenient route of administration. Orally disintegrating dosage forms, like soluble films and (mini-)tablets, appear promising for use in the pediatric population. New guidance for the development of pediatric medicines has been published, which provides considerations on how pediatric products should be designed. However, most of the considerations leave a lot of room for interpretations. Bearing in mind the different aspects discussed in the latest guideline, the use of orally disintegrating films and tablets, in particular, small-sized tablets, is discussed and reflected upon by providing evidence from the scientific literature. The available dosage forms for children are various and examples of currently licensed products for use in the pediatric population were compiled. Aspects such as the appropriateness for pediatrics, the choice of excipients, the opportunities for modified drug release preparations or fixed-dose combinations, the acceptability and palatability, and also limitations were discussed with respect to the new dosage forms of orally disintegrating films and mini-tablets. This paper points out that innovation in pediatric medicines are planned and should be encouraged; however, supported by the regulatory guidance, only general considerations are provided. Nevertheless, the guideline summarizes multiple points to consider during the development of medicines for pediatric use. Considering the scientific evidence and the regulatory guidance, orally disintegrating dosage forms, like soluble films and (mini-)tablets, offer an innovative solution for pediatric drug delivery.
口服给药是一种非侵入性的给药途径，因此非常方便。口腔崩解剂型，如可溶性薄膜和（迷你）片剂，在儿科人群中的应用前景广阔。关于儿科药物开发的新指南已经发布，该指南提供了有关儿科产品应如何设计的考量因素。然而，大多数考量因素都留有很大的解释空间。考虑到最新指南中讨论的不同方面，本文通过提供科学文献中的证据，对口腔崩解薄膜和片剂，特别是小型片剂的使用进行了讨论和反思。儿童可用的剂型多种多样，并汇编了目前已获许可用于儿科人群的产品示例。针对口腔崩解薄膜和迷你片剂等新剂型，讨论了其在儿科适用性、辅料选择、改良药物释放制剂或固定剂量组合的机会、可接受性和适口性等方面，以及局限性。本文指出，儿科药物的创新是有计划的，应该得到鼓励；然而，在监管指南的支持下，仅提供了一般性的考量因素。尽管如此，该指南总结了儿科用药开发过程中需要考虑的多个要点。考虑到科学证据和监管指南，可溶性薄膜和（迷你）片剂等口腔崩解剂型为儿科药物递送提供了一种创新解决方案。
