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XU Yinrong, SHENG Xiaoxia. A reliable crystallization process for the preparation of agomelatine form I[J]. Journal of China Pharmaceutical University, 2016, 47(2): 171-175. DOI: 10.11665/j.issn.1000-5048.20160208
Citation: XU Yinrong, SHENG Xiaoxia. A reliable crystallization process for the preparation of agomelatine form I[J]. Journal of China Pharmaceutical University, 2016, 47(2): 171-175. DOI: 10.11665/j.issn.1000-5048.20160208

A reliable crystallization process for the preparation of agomelatine form I

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  • A reliable crystallization process was developed for the preparation of stable agomelatine form I. This antisolvent crystallization was explored in ethanol-n-heptane by adding PVP and ethanol-water system by adding HPMC, respectively. Factors such as solvent, polymer, concentration of polymer, and solvent ratio were subjected to detailed examination. Accelerated and long-term stability observations indicates that the presence of polymeric additives in the crystallization process enhances the stability of agomelatine form I.
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