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Physiologically\u2010based pharmacokinetic (PBPK) models were constructed and verified for budesonide and formoterol with different inhalation devices, CXG87 (test (T) formulation) and Symbicort\u00ae Turbuhaler\u00ae (reference (R) formulation). The models were then used to evaluate local exposures at different peak inspiratory flow rates (PIFRs) and dose conditions. Local exposures of CXG87 were comparable to the R formulation at PIFR 50\u201380\u2009L\/min at the dose of 200\u2009\u03bcg\/6\u2009\u03bcg (budesonide\/ formoterol fumarate), which was determined as the recommended dose. At this dose, CXG87 had local exposure advantages compared with the R formulation at PIFR 30\u201350\u2009L\/min and better local exposure stability at PIFR 30\u201380\u2009L\/min in the indication population. The simulation results indicated that 200\u2009\u03bcg\/6\u2009\u03bcg can be selected as the study dose in the subsequent clinical study of CXG87 in indication patients. In addition, the clinical study could also include a lower flow rate (30\u201350\u2009L\/min) patient population to further evaluate the advantages of the modified formulation CXG87. This is the first study to predict CXG87 local exposure by a verified PBPK model.<\/jats:p>","DOI":"10.1002\/cpt.3695","type":"journal-article","created":{"date-parts":[[2025,5,1]],"date-time":"2025-05-01T09:59:02Z","timestamp":1746093542000},"page":"613-621","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Prediction of Local Drug Exposure of Dry Powder Inhaler CXG87 (budesonide\/formoterol) Using Physiologically\u2010Based Pharmacokinetic Model"],"prefix":"10.1002","volume":"118","author":[{"given":"Yuran","family":"Cao","sequence":"first","affiliation":[{"name":"School of Pharmacy Fudan University  Shanghai China"},{"name":"Phase I Clinical Research Center, Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuming","family":"Hu","sequence":"additional","affiliation":[{"name":"Yinghan Pharmaceutical Technology (Shanghai) Co., Ltd.  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