Molecular State of Active Pharmaceutical Ingredients in Ketoprofen Dermal Patches Characterized by Pharmaceutical Evaluation
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- Azuma Motoshige
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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- Fujii Mika
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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- Inoue Motoki
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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- Hisada Hiroshi
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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- Koide Tatsuo
- Division of Drugs, National Institute of Health Sciences
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- Kemper Mark
- Tornado Spectral Systems, Inc.
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- Yamamoto Yoshihisa
- Faculty of Pharmaceutical Sciences, Teikyo Heisei University
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- Suzuki Naoto
- School of Pharmacy, Nihon University
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- Suzuki Toyofumi
- School of Pharmacy, Nihon University
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- Fukami Toshiro
- Department of Molecular Pharmaceutics, Meiji Pharmaceutical University
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説明
<p>The molecular states of ketoprofen and the interaction between ketoprofen and other pharmaceutical excipients in the matrix layer were examined to determine their effect on the pharmaceutical properties of original and generic ketoprofen dermal patches (generic patches A and B). Molecular states of ketoprofen were evaluated using polarized light microscopy, Raman spectroscopy and powder X-ray diffraction. For the original ketoprofen patch, crystalline components were not observed in the matrix layer. However, crystalline ketoprofen was observed in the two generic ketoprofen patches. Moreover, the ketoprofen exhibited hydrogen bonding with the pharmaceutical excipients or patch materials in the generic products. Skin permeation of ketoprofen from the patches was evaluated using hairless mouse skin. Twelve hours after application, the original patch demonstrated the highest level of cumulative skin permeation of ketoprofen. This was followed by generic patch B while generic patch A showed the lowest level of permeation. Fluxes were calculated from the skin permeation profiles. The original patch was approx. 2.4-times faster compared with generic patch A and approximately 1.9-times faster compared with generic patch B. This investigation suggested that pharmaceutical properties such as skin permeability for these types of products are affected by the precipitation of crystalline ketoprofen in the matrix layer and the interaction of ketoprofen with the pharmaceutical excipients or patch materials.</p>
収録刊行物
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- Biological & Pharmaceutical Bulletin
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Biological & Pharmaceutical Bulletin 41 (9), 1348-1354, 2018-09-01
公益社団法人 日本薬学会
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詳細情報 詳細情報について
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- CRID
- 1390001288063828608
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- NII論文ID
- 130007479880
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- NII書誌ID
- AA10885497
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- ISSN
- 13475215
- 09186158
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- NDL書誌ID
- 029184950
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- PubMed
- 30175772
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- 使用不可