Abstract
This paper discloses six polymorphs of famoxadone obtained from polymorph screening, which were characterized by XRPD, DSC, and SEM. A study of solvent-mediated polymorphic transformation (SMPT) of famoxadone from the metastable Form II to the stable Form I in several mixed solvent systems at the temperature of 30 °C was also conducted. The transformation process was monitored by Process Analytical Technologies. It was confirmed that the Form II to Form I polymorphic transformation is controlled by the Form I growth process. The transformation rate constants depended linearly on the solubility difference value between Form I and Form II. Furthermore, the hydrogen-bond-donation/acceptance ability and dipolar polarizability also had an effect on the rate of solvent-mediated polymorphic transformation.
Highlights
Crystallization is the widely-used method for isolation pf a solid-state chemical compound from solution at the manufacturing scale, and it is governed and affected by thermodynamic and kinetic factors [1,2,3,4,5,6]
Solvent-mediated polymorphic transformation (SMPT) is a process where the metastable polymorph interacts with the solvent and subsequently transforms to a more stable polymorph by dissolution and crystallization
Form I, and the other five polymorph single crystals were not obtained by careful cultivation
Summary
Crystallization is the widely-used method for isolation pf a solid-state chemical compound from solution at the manufacturing scale, and it is governed and affected by thermodynamic and kinetic factors [1,2,3,4,5,6]. The metastable form is crystallized first, and this system undergoes every possible polymorphic structure before the thermodynamically-stable polymorph crystallizes from the solution [8]. Solvent-mediated polymorphic transformation (SMPT) is a process where the metastable polymorph interacts with the solvent and subsequently transforms to a more stable polymorph by dissolution and crystallization. SMPT has been extensively studied over the years It is useful for producing the thermodynamically-stable polymorph [12]. I in several mixed Form solvent has been studied, corresponding to mixed solvent thermodynamically-stable. I in systems several mixed solvent systems has been studied, corresponding systems including nitromethane/toluene, nitromethane/isopropylbenzene, acetone/m-xylene, to mixed solvent systems including nitromethane/toluene, nitromethane/isopropylbenzene, acetone/toluene, acetone/p-xylene,acetone/p-xylene, and acetone/mesitylene.
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