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$High Pressure Single Crystal Diffraction at PX^2$

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Published on: January 16, 2017

Parts per Million Powder X-ray Diffraction.

Justin A Newman¹, Paul D Schmitt¹, Scott J Toth¹

¹Department of Chemistry, Purdue University , West Lafayette, Indiana, United States.

Analytical Chemistry

|October 15, 2015

Summary

This summary is machine-generated.

This study introduces a combined second harmonic generation (SHG) microscopy and synchrotron powder X-ray diffraction (PXRD) method. This technique effectively detects trace crystalline active pharmaceutical ingredients in polymer blends, crucial for drug formulation stability.

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Area of Science:

Analytical Chemistry
Materials Science
Pharmaceutical Science

Background:

Crystalline active pharmaceutical ingredients (APIs) can impact drug product stability and bioavailability.
Detecting low concentrations of crystalline APIs in amorphous matrices is challenging.
Current methods may lack the sensitivity or spatial resolution for trace detection.

Purpose of the Study:

To demonstrate a novel combined SHG microscopy-guided synchrotron PXRD technique.
To assess the capability of this method for detecting trace crystalline APIs in polymer blends.
To improve analytical sensitivity in pharmaceutical formulation development.

Main Methods:

Utilizing second harmonic generation (SHG) microscopy for spatial guidance.
Employing synchrotron powder X-ray diffraction (PXRD) for crystalline phase analysis.
Integrating SHG microscopy with a minibeam collimator for synchrotron PXRD.

Main Results:

Successfully detected 100 ppm crystalline ritonavir in an amorphous hydroxypropyl methylcellulose matrix.
Achieved a high signal-to-noise ratio (>5000) for trace crystalline API detection.
Reduced background noise by minimizing the probed volume using SHG microscopy guidance.

Conclusions:

The combined SHG microscopy-guided synchrotron PXRD offers high sensitivity for trace crystalline API detection.
This technique enhances measurements in the pharmaceutical formulation pipeline.
Improved detection of low crystalline loading can optimize the stability and bioavailability of drug products.