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Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy

We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV(ODT)) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV(ODT) contained dispersed granules with diameters in the order of several hundred micrometers, which were comp...

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Autores principales: Yamamoto, Yoshihisa, Kajita, Mizuho, Hirose, Yutaro, Shimada, Naoki, Fukami, Toshiro, Koide, Tatsuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459943/
https://www.ncbi.nlm.nih.gov/pubmed/37631255
http://dx.doi.org/10.3390/pharmaceutics15082041
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author Yamamoto, Yoshihisa
Kajita, Mizuho
Hirose, Yutaro
Shimada, Naoki
Fukami, Toshiro
Koide, Tatsuo
author_facet Yamamoto, Yoshihisa
Kajita, Mizuho
Hirose, Yutaro
Shimada, Naoki
Fukami, Toshiro
Koide, Tatsuo
author_sort Yamamoto, Yoshihisa
collection PubMed
description We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV(ODT)) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV(ODT) contained dispersed granules with diameters in the order of several hundred micrometers, which were composed of the active pharmaceutical ingredient (API), as confirmed by infrared (IR) microspectroscopy. On the contrary, the API and inactive pharmaceutical ingredients (non-APIs) were homogeneously distributed in LV tablet (LV(T)) formulations. Microscopic IR spectroscopy and thermal analyses showed that LV(ODT) and LV(T) contained the API in different crystalline forms or environment around the API each other. Furthermore, powder X-ray diffraction showed that LV(T) contained a hemihydrate of the API, while LV(ODT) showed a partial transition to the monohydrate form. This result was confirmed by microscopic LF Raman spectroscopy. Moreover, this method confirmed the presence of thin layers coating the outer edges of the granules that contained the API. Spectra obtained from these thin layers indicated the presence of titanium dioxide, suggesting that the layers coexisted with a polymer that masks the bitterness of API. The microscopic LF Raman spectroscopy results in this study indicated new applications of this method in pharmaceutical science.
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spelling pubmed-104599432023-08-27 Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy Yamamoto, Yoshihisa Kajita, Mizuho Hirose, Yutaro Shimada, Naoki Fukami, Toshiro Koide, Tatsuo Pharmaceutics Article We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV(ODT)) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV(ODT) contained dispersed granules with diameters in the order of several hundred micrometers, which were composed of the active pharmaceutical ingredient (API), as confirmed by infrared (IR) microspectroscopy. On the contrary, the API and inactive pharmaceutical ingredients (non-APIs) were homogeneously distributed in LV tablet (LV(T)) formulations. Microscopic IR spectroscopy and thermal analyses showed that LV(ODT) and LV(T) contained the API in different crystalline forms or environment around the API each other. Furthermore, powder X-ray diffraction showed that LV(T) contained a hemihydrate of the API, while LV(ODT) showed a partial transition to the monohydrate form. This result was confirmed by microscopic LF Raman spectroscopy. Moreover, this method confirmed the presence of thin layers coating the outer edges of the granules that contained the API. Spectra obtained from these thin layers indicated the presence of titanium dioxide, suggesting that the layers coexisted with a polymer that masks the bitterness of API. The microscopic LF Raman spectroscopy results in this study indicated new applications of this method in pharmaceutical science. MDPI 2023-07-29 /pmc/articles/PMC10459943/ /pubmed/37631255 http://dx.doi.org/10.3390/pharmaceutics15082041 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Yamamoto, Yoshihisa
Kajita, Mizuho
Hirose, Yutaro
Shimada, Naoki
Fukami, Toshiro
Koide, Tatsuo
Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title_full Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title_fullStr Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title_full_unstemmed Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title_short Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy
title_sort pharmaceutical evaluation of levofloxacin orally disintegrating tablet formulation using low frequency raman spectroscopy
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10459943/
https://www.ncbi.nlm.nih.gov/pubmed/37631255
http://dx.doi.org/10.3390/pharmaceutics15082041
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