Characterization, Solubility, and Hygroscopicity of a Pharmaceutical Compound

Content overview

In this presentation, professor Martha Grover from Georgia Institute of Technology presents her recently published research on Characterization, Solubility, and Hygroscopicity of BMS-817399 [1].

In the research, characteristics of BMS-817399 that could influence the potential utility of the compound as active pharmaceutical ingredient (API) have been explored. The compound exists as a monohydrate (Form 1) but is physically unstable, as its crystal structure changes with variations in relative humidity and temperature. Thus, identifying a form that remains physically stable under fluctuating conditions of relative humidity was the objective of this work.

Solubilities of Form 1 in ethanol, isopropanol, acetone, and acetonitrile were obtained using a Crystal16 apparatus, but recrystallization only occurred at the condition investigated when the solvent was acetonitrile. XRD of solids from recrystallization in the Crystal16 apparatus and from larger-scale experiments confirmed the existence of a new form (Form 2) of the compound. Solubilities of Form 2 were subsequently determined using the Crystal16 apparatus. DSC and TGA confirmed Form 1 as a monohydrate and showed that Form 2 is anhydrous. Dynamic vapor sorption was used to show that the water content of Form 1 varied with relative humidity. Form 2 also became hygroscopic at elevated relative humidity, but XRD measurements confirmed that it exhibited physical stability.

[1] Publication: “Characterization, Solubility, and Hygroscopicity of BMS-817399,” R. Prasad, S. Kocevska, D. Skliar, M. A. Grover, R. W. Rousseau, Organic Process Research and Development, 28(8), 3119–3127 (2024). 

This presentation was presented during the webinar Characterization, Solubility, and Hygroscopicity of a Pharmaceutical Compound. 

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