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System for Efficacy and Cytotoxicity Screening of Inhibitors Targeting Intracellular Mycobacterium tuberculosis
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A Rapid Qualitative Screening Method for Isoniazid Tablets Using Handheld NIR Spectrometers in Two Countries.

Matthew Eady1, Jonelle Caison1,2, Mohammed Jinnah3

  • 1FHI 360-Product Quality Compliance Department, Durham, NC 27713, USA.

Molecules (Basel, Switzerland)
|June 28, 2023
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Summary

Handheld spectrometers can accurately screen isoniazid quality across different countries. This technology ensures essential medicine safety in global supply chains, even with sensor variations.

Keywords:
diffuse reflectanceglobal healthisoniazidnear-infraredportable spectroscopyquality compliancerapid testingsupply chaintuberculosis

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Area of Science:

  • Pharmaceutical analysis
  • Spectroscopy
  • Global health

Background:

  • Isoniazid is a crucial tuberculosis medication supplied globally.
  • Ensuring medication quality in resource-limited areas is vital for public health.
  • Handheld spectrometers offer a portable solution for quality compliance screening.

Purpose of the Study:

  • To develop a multi-location quality compliance screening method for isoniazid.
  • To assess the feasibility of using handheld spectrometers for brand-specific discrimination.
  • To evaluate a qualitative discrimination analysis method across different geographic locations.

Main Methods:

  • Collected spectral data from isoniazid tablets (N=482) using two handheld spectrometers (900-1700 nm) in the USA and South Africa.
  • Employed Mahalanobis distance thresholding for qualitative brand differentiation and similarity assessment.
  • Investigated brand-specific discrimination across five manufacturing sources.

Main Results:

  • Achieved 100% classification accuracy for brand 'A' when combining data from both locations.
  • Successfully differentiated other brands as dissimilar to brand 'A'.
  • The Mahalanobis distance method demonstrated robustness despite inter-sensor bias, with spectral peaks and excipient variations noted.

Conclusions:

  • Handheld spectrometers show significant promise for the compliance screening of isoniazid.
  • The developed method is effective for quality control of tablets in multiple geographic locations.
  • This approach supports the safety and efficacy of essential medicines in global supply chains.