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Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release.

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第一作者： Melanie,Dumarey

第一单位： Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden. melanie.dumarey@astrazeneca.com.

作者： Melanie,Dumarey ^[1] ; Tessa M,Carducci ^[2] ; Matthew J,Walworth ^[3] ; Casey J,Smith ^[3] ; Salvador,García-Muñoz ^[3] ; Sarah,Nielsen ^[4] ; Sylvaine,Jacquart ^[5] ; Ana Tavares,da Silva ^[5] ; Stan,Altan ^[6] ; Martin,Otava ^[7] ; Yanmei,Lan ^[8] ; Nikolay,Zaborenko ^[3]

作者单位： Global Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden. melanie.dumarey@astrazeneca.com. ^[1] Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave, Rahway, NJ, 07065, United States of America. ^[2] Synthetic Molecule Design and Development, Eli Lilly and Company, Indianapolis, IN, 46285, United States of America. ^[3] Janssen Supply Chain, Johnson & Johnson, New Brunswick, NJ, United States of America. ^[4] Janssen Pharmaceutica NV, Beerse, Belgium. ^[5] Manufacturing and Applied Statistics, Janssen Pharmaceutical R&D LLD, Raritan, NJ, 08869, United States of America. ^[6] Manufacturing and Applied Statistics, Janssen-Cilag S.R.O., Prague, Czechia. ^[7] Analytical Development, Pharmaceutical Sciences, Takeda, Cambridge, MA, 02139, United States of America. ^[8]

关键词 dissolution predictive dissolution modelling real-time release testing

医学主题词人类(Humans);投药, 口服(Administration, Oral);化学, 药物(Chemistry, Pharmaceutical);药物调剂(Drug Compounding);药用制剂(Pharmaceutical Preparations);溶解度(Solubility);药物批准(Drug Approval)

DOI 10.1208/s12248-025-01102-0

PMID 40579614

发布时间 2025-08-28

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