Key points and standard status of quality evaluation of oromucosal drug delivery preparations
10.19778/j.chp.2024.03.002
- VernacularTitle:口腔黏膜给药制剂质量评价要点及标准现状
- Author:
Liuliu YANG
1
;
Mingyan LI
;
Junqi ZHANG
;
Bing WANG
;
Yue SHANG
;
Fang CHEN
Author Information
1. 中国医药工业研究总院医药先进制造国家工程研究中心,上海 201203
- Keywords:
oromucosal drug delivery preparations;
ChP;
EP;
BP;
USP;
JP
- From:
Drug Standards of China
2024;25(3):220-226
- CountryChina
- Language:Chinese
-
Abstract:
Oromucosal drug delivery preparations offer advantages such as convenient administration,suitability for patients with dysphagia,rapid onset of action,and avoidance of first-pass metabolism in the liver.The 2020 edition of the Chinese Pharmacopoeia,EP11.0,BP2022,USP44-NF39,and JP18 all include relevant standards for the quality control of different oromucosal drug delivery systems.This article compares the differences in general re-quirements for oromucosal formulations among different countries and provides an overview of inspection items for marketed oral mucosal formulations and those documented in pharmacopoeias both domestically and internationally.Foreign pharmacopoeias include a wide range of oromucosal drug delivery formulations,with more refined quality control measures for systemic action.These findings can serve as a reference for the improvement and enhancement of standards for oromucosal drug delivery systems in China.
