Crystallization of Terutroban Sodium Salt Hydrate from the Deliquescent State | Zendy

Couvrat Nicolas | Zendy; Cartigny Yohann | Zendy; Linol Julie | Zendy; VaysseLudot Lucile | Zendy; Langlois Pascal | Zendy; Coquerel Gérard | Zendy

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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.

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