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<i><sub>ODT</sub></i>) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV<i><sub>ODT</sub></i> contained dispersed gran...
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| Format: | Article |
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MDPI AG
2023-07-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/15/8/2041 |
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| author | Yoshihisa Yamamoto Mizuho Kajita Yutaro Hirose Naoki Shimada Toshiro Fukami Tatsuo Koide |
| author_facet | Yoshihisa Yamamoto Mizuho Kajita Yutaro Hirose Naoki Shimada Toshiro Fukami Tatsuo Koide |
| author_sort | Yoshihisa Yamamoto |
| collection | DOAJ |
| description | We evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV<i><sub>ODT</sub></i>) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV<i><sub>ODT</sub></i> 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<i><sub>T</sub></i>) formulations. Microscopic IR spectroscopy and thermal analyses showed that LV<i><sub>ODT</sub></i> and LV<i><sub>T</sub></i> contained the API in different crystalline forms or environment around the API each other. Furthermore, powder X-ray diffraction showed that LV<i><sub>T</sub></i> contained a hemihydrate of the API, while LV<i><sub>ODT</sub></i> 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. |
| first_indexed | 2024-03-10T23:39:55Z |
| format | Article |
| id | doaj.art-ca74919177964349988b3ccdddb84317 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T23:39:55Z |
| publishDate | 2023-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-ca74919177964349988b3ccdddb843172023-11-19T02:35:49ZengMDPI AGPharmaceutics1999-49232023-07-01158204110.3390/pharmaceutics15082041Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman SpectroscopyYoshihisa Yamamoto0Mizuho Kajita1Yutaro Hirose2Naoki Shimada3Toshiro Fukami4Tatsuo Koide5Faculty of Pharmaceutical Sciences, Teikyo Heisei University, 4-21-2 Nakano, Nakano-ku, Tokyo 164-8530, JapanBio & Healthcare Division, HORIBA Ltd., 2 Miyanohigashi-cho, Kisshoin, Minami-ku, Kyoto 601-8510, JapanBio & Healthcare Division, HORIBA Ltd., 2 Miyanohigashi-cho, Kisshoin, Minami-ku, Kyoto 601-8510, JapanDepartment of Molecular Pharmaceutics, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, JapanDepartment of Molecular Pharmaceutics, Meiji Pharmaceutical University, 2-522-1 Noshio, Kiyose-shi, Tokyo 204-8588, JapanDivision of Drugs, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki 210-9501, JapanWe evaluated the pharmaceutical properties of levofloxacin (LV) in the form of an orally disintegrating tablet (LV<i><sub>ODT</sub></i>) to find a new usefulness of low frequency (LF) Raman spectroscopy. LV<i><sub>ODT</sub></i> 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<i><sub>T</sub></i>) formulations. Microscopic IR spectroscopy and thermal analyses showed that LV<i><sub>ODT</sub></i> and LV<i><sub>T</sub></i> contained the API in different crystalline forms or environment around the API each other. Furthermore, powder X-ray diffraction showed that LV<i><sub>T</sub></i> contained a hemihydrate of the API, while LV<i><sub>ODT</sub></i> 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.https://www.mdpi.com/1999-4923/15/8/2041levofloxacinorally disintegrating tabletcrystalline formlow frequency Raman spectroscopy |
| spellingShingle | Yoshihisa Yamamoto Mizuho Kajita Yutaro Hirose Naoki Shimada Toshiro Fukami Tatsuo Koide Pharmaceutical Evaluation of Levofloxacin Orally Disintegrating Tablet Formulation Using Low Frequency Raman Spectroscopy Pharmaceutics levofloxacin orally disintegrating tablet crystalline form 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 | levofloxacin orally disintegrating tablet crystalline form low frequency Raman spectroscopy |
| url | https://www.mdpi.com/1999-4923/15/8/2041 |
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