口服固体制剂经鼻胃管给药体外评价试验的一般考量
General considerations for in vitro testing of oral solid preparations administered through nasogastric tubes
孟永刚 1侯鹏 1王亚敏1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
鼻胃管给药是将药物通过适宜型号的鼻胃管经鼻腔插入胃内输送口服药的一种治疗方法,鼻胃管给药为无法正常吞咽的患者提供了一种重要的给药途径.鼻胃管给药的体外研究对保证药物准确的给药剂量、预期的安全性和有效性具有重要意义.本文参考国内外管饲给药体外研究相关指南及文献,结合审评工作经验,简要探讨鼻胃管给药体外评价研究需要关注的内容和技术要求.
Abstract
Nasogastric tube administration is a treatment method for oral administration of drugs through a suitable type of nasogastric tube inserted into the stomach through the nasal cavity.Administration via nasogastric tube provides an significant route for the patients who cannot swallow normally.In vitro testing of nasogastric tube administration was used to ensure the accurate dosage,expected safety and efficacy of each drug product.In the paper,combining the drug review experience,we briefly discussed the contents and technical requirements of nasogastric tube administration in vitro testing studies based on the guidance and literature about oral drug products administered via enteral feeding tube in China and abroad.
关键词
口服固体制剂/鼻胃管/肠内给药/体外研究Key words
oral solid drug products/nasogastric tube/enteral administration/in vitro testing引用本文复制引用
出版年
2024
NETL
NSTL
维普
万方数据