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Crystal structures and physicochemical properties of amisulpride polymorphs.
Wen-Peng Zhang1, Dong-Ying Chen1
1Laboratory of Pharmaceutical Analysis, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Rd. Zuchongzhi, Zhangjiang Hi-Tech Park, Shanghai 201203, China; University of Chinese Academy of Sciences, Beijing 100049, China.
Journal of Pharmaceutical and Biomedical Analysis
|April 4, 2017
Summary
A new polymorphic form of amisulpride (Form II) was discovered, exhibiting lower hygroscopicity and improved solubility compared to Form I. This finding suggests Form II as a promising alternative for drug formulation development.
Area of Science:
- Pharmaceutical Sciences
- Solid-State Chemistry
- Crystallography
Background:
- Amisulpride is an antipsychotic medication.
- Understanding drug polymorphism is crucial for effective formulation.
- Polymorphs can exhibit different physicochemical properties.
Purpose of the Study:
- To investigate the crystal structures of amisulpride polymorphs.
- To characterize the physicochemical properties of these polymorphs.
- To identify potential new solid forms for amisulpride formulation.
Main Methods:
- Comprehensive solid-state screening.
- Single crystal X-ray structure analysis (SXRD).
- Powder X-ray diffraction (PXRD), dynamic vapor sorption (DVS), and thermal analysis (TGA, DSC).
Main Results:
- A new polymorphic form, Form II, was discovered alongside the known Form I.
- Both forms are conformational polymorphs, differing in the ethylsulfonyl group.
- Form II demonstrated reduced hygroscopicity and enhanced solubility over Form I.
Conclusions:
- Form II represents a novel polymorphic form of amisulpride.
- The distinct conformational differences influence hygroscopicity and solubility.
- Form II shows potential as a superior solid form for amisulpride-based formulations.