Trospium Chloride: Unusual Example of Polymorphism Based on Structure Disorder

Skořepová, E¹., Čejka, J.¹, Hušák, M.¹, Eigner, V.^1,3, Rohlíček, J.^1,3, Šturc, A.², Kratochvíl, B.¹,

¹VŠCHT Praha, Technická 5, 166 28 Praha 6; ²Interpharma Praha, a.s. Komořanská 955, Praha 12; ³Fyzikální ústav AVČR, Na Slovance 2, 182 21 Praha 8

Cryst. Growth Des. 13 (2013), 5193–5203. IF=4,689

The results uncover the first ever disorder- and pseudosymmetry-based polymorphism, which was almost undetectable by standard powder diffraction methods. It combines both very rare structural effect and interesting legal problem, as the powder diffraction pattern is still considered the prime criterion of phase identification in patent law. As trospium chloride was believed to be a well-defined compound with no polymorphism, the currently used analytical methods should be revised for phase characterization in pharmaceutical industry.

The scientific part of this study was done by ICT Prague staff. The co-author affiliated  to Interpharma Praha take care about the investigated material source primary.