Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Yoshihisa Yamamoto
* ORCID logo ,
Mizuho Kajita
,
Yutaro Hirose
,
Naoki Shimada
,
Toshiro Fukami
* ORCID logo ,
Tatsuo Koide
Version 1 : Received: 30 May 2023 / Approved: 2 June 2023 / Online: 2 June 2023 (04:37:48 CEST)

A peer-reviewed article of this Preprint also exists.

Yamamoto, Y.; Kajita, M.; Hirose, Y.; Shimada, N.; Fukami, T.; Koide, T. Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy. Pharmaceutics 2023, 15, 2041. Yamamoto, Y.; Kajita, M.; Hirose, Y.; Shimada, N.; Fukami, T.; Koide, T. Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy. Pharmaceutics 2023, 15, 2041.

Abstract

: We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LVODT) to find a new usefulness of low frequency (LF) Raman spectroscopy. LVODT 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 (LVT) formulations. Microscopic IR spectroscopy and thermal analyses showed that LVODT and LVT contained the API in different crystalline forms or environment around the API each other. Furthermore, powder X-ray diffraction showed that LVT contained a hemihydrate of the API, while LVODT 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.

Keywords

levofloxacin; orally disintegrating tablet; crystalline form; low frequency Raman spectroscopy

Subject

Medicine and Pharmacology, Pharmacy

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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