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儿科口服制剂:自 2007 年以来市售儿科口服制剂的更新综述。

Pediatric Oral Formulations: An Updated Review of Commercially Available Pediatric Oral Formulations Since 2007.

出版信息

J Pharm Sci. 2019 Apr;108(4):1335-1365. doi: 10.1016/j.xphs.2018.11.013. Epub 2018 Nov 14.

Abstract

Oral pediatric formulations are either ready-to-use or require manipulation and multiuse or single-use. Strong encouragement for preservative-free pediatric formulations has resulted in fewer multiuse solutions or suspensions in favor of single-use solid oral dosage forms. This updated review covering new pediatric formulations marketed in the United States of America, Europe, and Japan spanning the years 2007 to mid-2018 identified 16 types of pediatric oral formulations of which 7 are ready-to-use and 9 require manipulation, and 51 total new pediatric oral formulations of which 21 are ready-to-use and 30 require manipulation. Ready-to-use formulations include oral solution, oral suspension, oral soluble film, tablet, scored tablets, orally disintegrating tablet, chewable tablet, and mini-tablets. Formulations requiring manipulation include sprinkle capsule, powder for oral solution, powder for oral suspension, granules for oral suspension, oral powder, oral granules, tablet, dispersible tablet, dispersible scored tablet, tablet for oral suspension, and mini-tablets (oral granules). Significant advances in packaging technology include filling mini-tablets, granules, or powders into sachets, stick packets, blisters, and 2-piece capsules. The future of pediatric oral formulations will increasingly be with user-friendly, preservative-free, taste-masked formulations including multiparticulate single-use solid dosage forms including mini-tablets, orally disintegrating tablets, and sprinkle capsules with or without a specialized package configuration.

摘要

口腔儿科制剂有即用药型或需要调配和多次使用或单次使用。强烈鼓励使用无防腐剂的儿科制剂,导致多次使用的溶液或混悬剂减少,转而采用单次使用的固体制剂。本综述更新涵盖了 2007 年至 2018 年年中期间在美国、欧洲和日本上市的新儿科制剂,确定了 16 种儿科口腔制剂,其中 7 种为即用药型,9 种需要调配,51 种新儿科口腔制剂,其中 21 种为即用药型,30 种需要调配。即用药型制剂包括口服溶液、口服混悬剂、口服速溶膜、片剂、刻痕片剂、口腔崩解片、咀嚼片和迷你片剂。需要调配的制剂包括撒粉胶囊、口服溶液用粉末、口服混悬剂用粉末、口服混悬剂用颗粒、口腔粉剂、口腔颗粒剂、片剂、分散片、分散片剂、口服混悬剂片剂和迷你片剂(口腔颗粒剂)。包装技术的显著进步包括将迷你片剂、颗粒剂或粉末填充到小袋、棒状包、泡罩和 2 件式胶囊中。未来的儿科口腔制剂将越来越倾向于使用用户友好、无防腐剂、掩味的制剂,包括多颗粒型单次使用固体制剂,包括迷你片剂、口腔崩解片和撒粉胶囊,无论是否采用特殊包装配置。

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