Leveraging Synergistic Solubility in the Development of a Direct Isolation Process for Nemtabrutinib
ORGANIC PROCESS RESEARCH & DEVELOPMENT(2023)
摘要
We report the process development for the active pharmaceutical ingredient (API) step of the commercial manufacturing route to nemtabrutinib (MK-1026), a reversible Bruton's Tyrosine Kinase (BTK) inhibitor currently under investigation for the treatment of several hematological malignancies. Significant improvements on process efficiency were achieved by a direct isolation process leveraging optimal reaction conditions and synergistic API solubility in an ethanol/water system. In combination with additional robustness improvements on impurity control, an efficient, practical, and scalable synthesis of nemtabrutinib was developed.
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关键词
SNAr,API,synergistic solubility,polish filtration,BTK inhibitor,crystallization,impurity crystallization kinetics
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