Evaluation of particle size distribution of sub-visible particles in powder injections with different packaging forms – small-sized sub-visible particles should not be ignored

Author:

Wang Tao1,Lu Enhao1,Dai Qiwen2,Huang Xueli1,Yao Qiquan2,Sha Xianyi1

Affiliation:

1. Department of Pharmaceutics, School of Pharmacy, Key Laboratory of Smart Drug Delivery, Fudan University, Shanghai, China

2. Alpharmaca Inc., Shanghai, China

Publisher

Informa UK Limited

Subject

Organic Chemistry,Drug Discovery,Pharmaceutical Science,Pharmacology

Reference23 articles.

1. National adverse drug reaction monitoring annual report. China: National Medical Products Administration. 2020; https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/gzwj/gzwjyp/20210325170127199.html.

2. Guideline for basic intravenous infusion assessment in clinical use. China Pharmaceutical Packaging Association. 2018; https://cnppa.org/index.php/Home/Bz/show_2019/id/941.html.

3. United States Pharmacopeia 43 and National Formulary 38. 2020 ed. The United States Pharmacopeial Convention; 2020.

4. Determination of insoluble particles in injection and its effect on microcirculation function;Huihui L;China Pharm,2015

5. Effect of small-sized insoluble particles on inflammation-related indexes in injection;Jianghui Q;China J Pharm Econ,2016

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