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Article

Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

1
Department of Chemistry, Marian University, Indianapolis, IN 46222, USA
2
College of Osteopathic Medicine, Marian University, Indianapolis, IN 46222, USA
3
AbbVie Inc., North Chicago, IL 60064, USA
*
Author to whom correspondence should be addressed.
Academic Editors: Carlos Eduardo Sabino Bernardes and Chao Wang
Molecules 2021, 26(3), 610; https://doi.org/10.3390/molecules26030610
Received: 31 December 2020 / Revised: 20 January 2021 / Accepted: 21 January 2021 / Published: 25 January 2021
(This article belongs to the Special Issue Solid-State of Organic Pharmaceutical Compounds)
Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging. View Full-Text
Keywords: mass spectrometry imaging; MSI; ELDI; agglomeration; crystallinity; pharmaceuticals mass spectrometry imaging; MSI; ELDI; agglomeration; crystallinity; pharmaceuticals
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MDPI and ACS Style

Van Meter, M.I.; Khan, S.M.; Taulbee-Cotton, B.V.; Dimmitt, N.H.; Hubbard, N.D.; Green, A.M.; Webster, G.K.; McVey, P.A. Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging. Molecules 2021, 26, 610. https://doi.org/10.3390/molecules26030610

AMA Style

Van Meter MI, Khan SM, Taulbee-Cotton BV, Dimmitt NH, Hubbard ND, Green AM, Webster GK, McVey PA. Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging. Molecules. 2021; 26(3):610. https://doi.org/10.3390/molecules26030610

Chicago/Turabian Style

Van Meter, Mariann I., Salah M. Khan, Brynne V. Taulbee-Cotton, Nathan H. Dimmitt, Nathan D. Hubbard, Adam M. Green, Gregory K. Webster, and Patrick A. McVey. 2021. "Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging" Molecules 26, no. 3: 610. https://doi.org/10.3390/molecules26030610

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