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Crystallization of Terutroban Sodium Salt Hydrate from the Deliquescent State
Author(s) -
Couvrat Nicolas,
Cartigny Yohann,
Linol Julie,
VaysseLudot Lucile,
Langlois Pascal,
Coquerel Gérard
Publication year - 2015
Publication title -
chemical engineering and technology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.403
H-Index - 81
eISSN - 1521-4125
pISSN - 0930-7516
DOI - 10.1002/ceat.201400692
Subject(s) - crystallization , hydrate , anhydrous , chemical engineering , sodium , relative humidity , thermal stability , materials science , chemistry , thermodynamics , organic chemistry , physics , engineering
Terutroban sodium salt (Teru‐Na) is a solid active pharmaceutical ingredient initially produced in its anhydrous form. The crystallization of a new dihydrate was established using liquid‐assisted grinding and the liquid‐liquid interface process. The stability of the Teru‐Na crystalline phases was investigated as a function of temperature and relative humidity. A combination of analytical tools (spectroscopic, thermal, and vapor sorption analyses) highlighted the remarkable stability of the dihydrate, in particular under variable storage conditions. A rationalization of the stability hierarchy was proposed by means of phase diagrams.