On the dimorphism of prednisolone: The topological pressure-temperature phase diagram involving forms I and II - Normandie Université Access content directly
Journal Articles International Journal of Pharmaceutics Year : 2022

On the dimorphism of prednisolone: The topological pressure-temperature phase diagram involving forms I and II

Abstract

The dimorphism of the corticosteroid anti-inflammatory drug prednisolone has been investigated by the construction of a topological pressure–temperature phase diagram, using crystallographic and calorimetric data. The system is enantiotropic, because the temperature of the I-II equilibrium under atmospheric conditions (400–463 K) is lower than that of the two melting equilibria (518.7 K for form II and 526.3 K for form I). The slope of the I-II equilibrium in the pressure–temperature phase diagram is negative and relatively steep; therefore, form II, which is the stable form at room temperature, will not easily encounter conditions where form I will become stable even under industrial processing conditions. On the other hand, extreme small amounts of form I have been observed to spontaneously transform into form II in a time interval of about six years at room temperature and it can be concluded that although form I is very persistent under ambient conditions, it does slowly convert into form II. Moreover, the system does not obey the density rule.

Dates and versions

hal-03932071 , version 1 (10-01-2023)

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Cite

M. Bauer, F. Lacoulonche, R. Céolin, M. Barrio, I. Khichane, et al.. On the dimorphism of prednisolone: The topological pressure-temperature phase diagram involving forms I and II. International Journal of Pharmaceutics, 2022, 624, pp.122047. ⟨10.1016/j.ijpharm.2022.122047⟩. ⟨hal-03932071⟩
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