Highlighted Paper selected by Editor-in-Chief : In Vivo Drug Dissolution in Human Oral Cavity from Orally Disintegrating Tablet and Comparability with in Vitro Testing

• Katayama Tsuyoshi

  Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka Pharmaceutical Research and Technology Division, Central Laboratories, Towa Pharmaceutical Co., Ltd.

• Uchida Shinya

  Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka

• Kamiya Chiaki

  Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine

• Tanaka Shimako

  Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka

• Kashiwagura Yasuharu

  Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka

• Hakamata Akio

  Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine

• Odagiri Keiichi

  Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine Center for Clinical Research, Hamamatsu University School of Medicine

• Inui Naoki

  Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine

• Watanabe Hiroshi

  Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine

• Namiki Noriyuki

  Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka

書誌事項

タイトル別名

• <i>In Vivo</i> Drug Dissolution in Human Oral Cavity from Orally Disintegrating Tablet and Comparability with <i>in Vitro</i> Testing

抄録

We examined the amlodipine dissolution from orally disintegrating tablets (ODTs) in vivo in the human oral cavity. Additionally, 5 different in vitro short dissolution test methods (Tricorptester, magnetic stirrer, rotating injection syringe, paddle apparatus, shaking) were used to evaluate dissolution and the results were compared to those obtained with the human volunteers. Various amlodipine ODTs with different levels of physical masking effectiveness were manufactured using the RACTAB^® technique. Quantitative findings showed that amlodipine dissolution from ODT was dependent on time in the oral cavity and the amount of coating applied for physical masking. We also found that dissolution in the oral cavity was best correlated to that in in vitro short dissolution tests with a time period of 30 s. For more detailed evaluations, mean prediction error, mean absolute error, and root mean square error values were calculated, each of which was lowest with the Tricorptester method among all of the investigated test methods. Our results indicate that mimicking of the inside of the human oral cavity is accurate with a testing time of 30 s, while the Tricorptester method was the most preferable of all in vitro tests investigated in this study.

収録刊行物

• ＣＨＥＭＩＣＡＬ　＆　ＰＨＡＲＭＡＣＥＵＴＩＣＡＬ　ＢＵＬＬＥＴＩＮ

  ＣＨＥＭＩＣＡＬ　＆　ＰＨＡＲＭＡＣＥＵＴＩＣＡＬ　ＢＵＬＬＥＴＩＮ 66 (10), 999-1005, 2018-10-01

  公益社団法人 日本薬学会

キーワード

• amlodipine
• orally disintegrating tablet
• dissolution
• oral cavity
• bitterness masking
• <i>in vitro</i> short dissolution test

詳細情報

• CRID: 1390282763049871488
• NII論文ID: 130007491024
• NII書誌ID: AA00602100
• DOI: 10.1248/cpb.c18-00492
• ISSN: 13475223
• ISSN: 00092363
• NDL書誌ID: 029238295
• PubMed: 30270246
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I029238295
• Web Site: https://www.jstage.jst.go.jp/article/cpb/66/10/66_c18-00492/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2019149491
• 本文言語コード: en
• データソース種別:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• 抄録ライセンスフラグ: 使用不可