基于"质量源于设计"理念研制地拉罗司分散片
Preparation of Deferasirox Dispersible Tablets Based on the Concept of Quality by Design
宗在伟 1王宇成1
作者信息
- 1. 江苏奥赛康药业有限公司,江苏南京 211112
- 折叠
摘要
基于质量源于设计理念,通过因果矩阵结合故障模式与影响分析筛选得到影响地拉罗司分散片质量的关键风险因子.使用Minitab 17软件进行全因子试验设计,以15 min溶出率为评价指标,优化内加微晶纤维素占比、内加交聚维酮占比和黏合剂(PVPK30)浓度.经过验证性试验确认,制备的3批地拉罗司分散片在含0.5％Tween-20的pH 1.0或pH 4.5介质中的溶出率均低于40％,在含0.5％Tween-20的pH 6.8介质中15 min溶出率大于90％.自制分散片的体外溶出行为与参比制剂(恩瑞格®)相似.
Abstract
Based on the concept of quality by design,the key risk factors affecting the quality of deferasirox dispersible tablets were screened out by cause and effect matrix combined with failure mode and effect analysis.The proportion of internal adding microcrystalline cellulose,the proportion of internal adding cross-linked polyvinylpyrrolidone(PVPP)and the concentration of adhesive(PVP K30)were optimized by a full-factorial design with Minitab 17 Software,with the dissolution rate at 15 min as the evaluation index.By implementing validated experiments,the dissolution rates of three batches of the self-made deferasirox dispersible tablets were lower than 40％in pH 1.0 or pH 4.5 media containing 0.5％Tween-20,but the dissolution rates at 15 min were more than 90％in pH 6.8 medium containing 0.5％Tween-20.And the dissolution behaviors between the self-made dispersible tablets and the reference listed drug(Exjade ®)were similar.
关键词
质量源于设计/地拉罗司/分散片/体外溶出Key words
quality by design/deferasirox/dispersible tablet/in vitro dissolution引用本文复制引用
出版年
2024
NETL
NSTL
万方数据