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Solid-state phase transitions of AG337, an antitumor agent
1College of Pharmacy, University of Minnesota, Minneapolis 55455, USA.
Pharmaceutical Development and Technology
|December 1, 1999
Summary
This study characterized solid forms of AG337, identifying five anhydrate polymorphs and three hydrates. Conditions for their interconversion were determined, revealing transformations influenced by humidity and temperature.
Area of Science:
- Solid-state chemistry
- Pharmaceutical sciences
- Materials characterization
Background:
- AG337 is a compound with multiple solid-state forms.
- Understanding these forms and their interconversions is crucial for pharmaceutical development and formulation.
Purpose of the Study:
- To conduct detailed solid-state characterization of AG337's various forms.
- To determine the conditions governing the interconversion between these solid forms.
Main Methods:
- Utilized differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), hot stage microscopy, Karl Fischer titrimetry, and X-ray powder diffractometry (XRD).
- Employed variable temperature XRD and TGA coupled with FTIR (TGA/FTIR) for advanced solid-state analysis.
- Investigated hydration and dehydration processes under varying relative humidity (RH) and temperature conditions.
Main Results:
- Identified five anhydrate polymorphic forms (I alpha to I epsilon) and three hydrates: hemihydrate (II), monohydrate (III), and dihydrate (IV).
- Established specific RH and temperature conditions for interconversion between anhydrate and hydrate forms.
- Demonstrated that heating hydrates II and III yields specific anhydrate polymorphs (I beta and I gamma), while vacuum storage yields I delta and I epsilon.
Conclusions:
- Variable temperature XRD and TGA/FTIR provided critical insights into solid-state behavior and thermal events.
- Confirmed thermal events in specific temperature ranges correspond to water loss and hydrogen chloride loss.
- The study successfully characterized AG337 solid forms and their interconversion pathways, essential for its handling and application.
