Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale.

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第一作者： Raghu V G,Peddapatla

第一单位： SSPC Pharmaceutical Research Centre, School of Pharmacy, University College Cork, T12 K8AF Cork, Ireland.

作者： Raghu V G,Peddapatla ^[1] ; Gerard,Sheridan ^[2] ; Conor,Slevin ^[2] ; Shrikant,Swaminathan ^[3] ; Ivan,Browning ^[2] ; Clare,O'Reilly ^[3] ; Zelalem A,Worku ^[4] ; David,Egan ^[2] ; Stephen,Sheehan ^[2] ; Abina M,Crean ^[2]

作者单位： SSPC Pharmaceutical Research Centre, School of Pharmacy, University College Cork, T12 K8AF Cork, Ireland. ^[1] Alkermes Pharma Ireland Limited, N37 EA09 Athlone, Ireland. ^[2] Pharmaceutical Manufacturing Technology Centre (PMTC), Bernal Institute, University of Limerick, V94 T9PX Limerick, Ireland. ^[3] Alkermes Inc., Waltham, MA 02451, USA. ^[4]

关键词 direct compression powder flow process model process optimization quality by design tablet weight variability

DOI 10.3390/pharmaceutics13071033

PMID 34371725

发布时间 2021-08-13

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