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- W2894736466 abstract "Salt disproportionation is a major issue for pharmaceutical products containing a salt form of a weakly basic drug, because conversion to the free base during processing or storage in the presence of excipients may negatively impact stability and bioperformance of the drug product. Several factors influencing disproportionation tendency have been elucidated; however, a complete mechanistic understanding of this phenomenon is still lacking. Specifically, it is unclear if the crystal structure of the salt plays a role, beyond influencing the salt solubility. Herein, by utilizing model compounds with similar pKa and pHmax values, and hence similar thermodynamic driving forces for disproportionation, we demonstrate that salt crystal structure appears to play a major role in influencing disproportionation tendency. Some salts with low pHmax values were found to be resistant to disproportionation, while other systems transformed to the free base following contact with the basic excipient, magnesium stearate. Fo..." @default.
- W2894736466 created "2018-10-12" @default.
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- W2894736466 date "2018-10-05" @default.
- W2894736466 modified "2023-09-24" @default.
- W2894736466 title "Assessing the Risk of Salt Disproportionation Using Crystal Structure and Surface Topography Analysis" @default.
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- W2894736466 doi "https://doi.org/10.1021/acs.cgd.8b01188" @default.
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