Squires Liza A, Lombardi Donald P, Sjostedt Philip, Thompson Charles A
1 Shire LLC, Wayne, PA, USA.
2 Institute for Pediatric Innovation, Cambridge, MA, USA.
Ther Innov Regul Sci. 2013 Sep;47(5):533-541. doi: 10.1177/2168479013500288.
Palatability and swallowability of oral dosage forms are important considerations in the development of medications for pediatric populations. As a result of recent legislation, the number of pharmaceutical products being developed with formulations for children is increasing. However, there are limited recommendations and published literature regarding appropriate palatability and swallowability assessment scales in pediatric patients.
This systematic literature review aimed to identify and evaluate tools currently utilized to assess palatability and swallowability in clinical trials for pediatric oral dosage forms and identify any potential relationships between palatability and treatment adherence. Literature databases were searched for clinical trials that evaluated palatability of oral dosage forms targeted for pediatric patients. The searches were limited to papers in the English language from January 2008 to March 2013.
A total of 137 citations were identified, with 27 articles included in the final full-text analysis.
Various limitations to this systematic review exist, primarily focused on the unavailability of published, early phase development data related to palatability. However, based on results of this review, palatability is often assessed in clinical trials of pediatric dosage forms through the utilization of 2 unvalidated, yet widely accepted, visual scales. There is no standard statistical methodology for analyzing the results of these scales or the cross-comparison of results across studies. Limited evidence regarding a correlation between palatability and treatment adherence in pediatric patients was identified.
口服剂型的适口性和吞咽性是儿科用药研发中的重要考量因素。由于近期的法规要求，针对儿童剂型开发的药品数量不断增加。然而，关于儿科患者适口性和吞咽性评估量表的推荐和已发表文献有限。
本系统文献综述旨在识别和评估目前在儿科口服剂型临床试验中用于评估适口性和吞咽性的工具，并确定适口性与治疗依从性之间的潜在关系。检索文献数据库以查找评估儿科患者口服剂型适口性的临床试验。检索限于2008年1月至2013年3月的英文论文。
共识别出137篇文献，最终全文分析纳入27篇文章。
本系统综述存在各种局限性，主要集中在缺乏已发表的与适口性相关的早期研发数据。然而，基于本综述结果，在儿科剂型临床试验中，适口性通常通过使用2种未经验证但被广泛接受的视觉量表进行评估。对于分析这些量表的结果或跨研究结果的交叉比较，没有标准的统计方法。关于儿科患者适口性与治疗依从性之间相关性的证据有限。
