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Characterization of polymorphic solid-state changes using variable temperature X-ray powder diffraction.

Milja Karjalainen¹, Sari Airaksinen, Jukka Rantanen

¹Pharmaceutical Technology Division, Faculty of Pharmacy, University of Helsinki, Finland. milja.karjalainen@helsinki.fi

Journal of Pharmaceutical and Biomedical Analysis

|August 9, 2005

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Variable temperature X-ray powder diffraction (VT-XRPD) effectively characterized solid-state polymorphic changes in pharmaceutical materials upon heating. Different compounds exhibited unique transformations, highlighting VT-XRPD

Area of Science:

Solid-state chemistry
Pharmaceutical materials science
Crystallography

Background:

Understanding solid-state transformations is crucial for pharmaceutical development.
Polymorphism significantly impacts drug stability and bioavailability.
Heating can induce significant changes in crystalline pharmaceutical compounds.

Purpose of the Study:

To investigate solid-state changes in pharmaceutical materials during heating using variable temperature X-ray powder diffraction (VT-XRPD).
To characterize the thermal behavior and polymorphic transitions of sulfathiazole, theophylline, and nitrofurantoin.
To assess the utility of VT-XRPD in analyzing heating-induced solid-state transformations.

Main Methods:

Variable temperature X-ray powder diffraction (VT-XRPD) was employed.

Related Experiment Videos

Model pharmaceutical compounds including sulfathiazole, theophylline, and nitrofurantoin were studied.

Solid-state structural and crystallographic changes were monitored as a function of temperature.

Main Results:

Sulfathiazole polymorph SUTHAZ01 demonstrated high thermal stability, while SUTHAZ02 transformed to SUTHAZ01 upon heating.
Theophylline monohydrate converted to its anhydrous form via a metastable intermediate.
Nitrofurantoin monohydrate transformed to its anhydrous form through an amorphous phase, with initial decreases and subsequent increases in crystallinity.
Crystallinity remained high and stable for SUTHAZ01, SUTHAZ02, and theophylline monohydrate.
Average crystallite sizes of theophylline and nitrofurantoin monohydrates decreased during heating, with nitrofurantoin's size recovering at higher temperatures.

Conclusions:

VT-XRPD is an effective technique for characterizing polymorphic transitions and solid-state changes in pharmaceutical compounds during heating.
The study elucidated specific thermal transformation pathways for sulfathiazole, theophylline, and nitrofurantoin.
Understanding these transformations is vital for controlling pharmaceutical solid forms and ensuring product quality.