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A quality by design (QbD) case study on entericcoated pellets: Screening of critical variables and establishment of design space at laboratory scale

查看全文 作　　者：Shuling [1,2]Kan;Jing [1]Lu;Jianping [1]Liu;Junlin [1]Wang;Yi [1]Zhao 高影响力作者 机构地区：[1]Department of Pharmaceutics,China Pharmaceutical University,Nanjing 210009,China;[2]Jiangsu Aosaikang Pharmaceutical Co.,Ltd.,Nanjing 210009,China高影响力机构 出　　处：《Asian Journal of Pharmaceutical Sciences》索引2014年第9卷第5期,共11页高影响力期刊 基　　金：This study is financially supported by the major project of National College Students Innovation Project for the R&D of Novel Drugs(No.J1030830). 摘　　要：The study aims to prepare naproxen enteric-coated pellets(NAP-ECPs)by fluid-bed coating using QbD principle.Risk assessment was firstly performed by using failure mode and effect analysis(FMEA)methodology.A PlacketteBurman design was then used for assessment of the most important variables affecting enteric-coated pellets characteristics.A BoxeBehnken design was subsequently used for investigating the main,interactive,and quadratic effects of these variables on the response.By FMEA we discovered that eight factors should be considered to be high/important risk variables as compared with others.The responses of acid resistance and cumulative drug release were taken as critical quality attributes(CQAs).Pareto ranking analyses indicated that the coating weight gain(X_(7)),triethyl citrate percentage(X_(1))and glycerol monostearate percentage(X_(2))were the most significant factors affecting the selected responses out of the eight high-risk variables.Optimization with response surface method(RSM)further fully clarified the relationship between X_(7),X_(1),X_(2) and CQAs,and design space was established based on the constraints set on the responses.Due to the extreme coincidence of the predicted value generated by model with the observed value,the accuracy and robustness of the model were confirmed.It could be concluded that a promising NAP-ECPs was successfully designed using QbD approach in a laboratory scale. 关 键 词：Fluid-bed coating PlacketteBurman design BoxeBehnken design NAPROXEN Quality by design
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