Application of "Quality by Design" in the preparation of acetaminophen sustained-release tablets by 3D printing
10.16438/j.0513-4870.2020-0336
- VernacularTitle:“质量源于设计”在3D打印法制备对乙酰氨基酚缓释片中的应用
- Author:
Bo-shi LIU
1
;
Zeng-ming WANG
2
;
Hui ZHANG
2
;
Jing GAO
2
;
Nan LIU
2
;
Xiang GAO
2
;
Meng LI
2
;
Ai-ping ZHENG
2
Author Information
1. Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Academy of Military Sciences, Beijing 100850, China; 93152 Unit Hospital of Chinese People's Liberation Army, Tonghua 134000, China
2. Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Academy of Military Sciences, Beijing 100850, China
- Publication Type:Research Article
- Keywords:
computer aided design;
hot melt extrusion;
three-dimensional printing;
acetaminophen;
sustained release preparation;
personalised medicine
- From:
Acta Pharmaceutica Sinica
2020;55(11):2719-2727
- CountryChina
- Language:Chinese
-
Abstract:
The aim of this study is to prepare acetaminophen sustained-release tablets by hot melt extrusion 3D printing technology based on the concept of "Quality by Design" (QbD). Firstly, the failure mode and effect analysis (FMEA) was used to determine the critical process parameters (CPPs), then full-factor experimental design was used to analyze the critical quality attributes (CQAs) and to establish the design space. The results showed that the content of plasticizer, the path spacing and the shell numbers are independent variable for the experimental design. The design space was concluded to be plasticizer content: 9%, and the shell number: 3-5, the path spacing: 1.05-1.2 mm. In this study, 3D printing technology was used to prepare acetaminophen sustained-release tablets in accordance with the concept of QbD, which improved the durability of the process and ensured the uniform and controllable quality of the preparation and also provided experimental basis for personalised medicine.
