Switching from batch to continuous granulation: A case study of metoprolol succinate ER tablets.

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作者： Lalith,Kotamarthy ^[1] ; Xin,Feng ^[2] ; Alaadin,Alayoubi ^[2] ; Pradeep,Kumar Bolla ^[2] ; Rohit,Ramachandran ^[3] ; Muhammad,Ashraf ^[2] ; Thomas,O'Connor ^[2] ; Ahmed,Zidan ^[4]

作者单位： Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA; Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, USA. ^[1] Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA. ^[2] Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, USA. ^[3] Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, USA. Electronic address: Ahmed.Zidan@fda.hhs.gov. ^[4]

关键词 Continuous manufacturing Design space Extended-release tablets Formulation High-shear granulation Oral solid dosage processing Twin-screw granulation

主题词药物调剂(Drug Compounding);辅药(Excipients);美托洛尔(Metoprolol);粒子大小(Particle Size);溶解度(Solubility);片剂(Tablets);工艺学, 制药(Technology, Pharmaceutical)

DOI 10.1016/j.ijpharm.2022.121598

PMID 35202728

发布时间 2022-03-22

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准确一般字义偏差语意偏离译文作用小提交