Improvement of the method for detection of falsified medicines using impurity profiling

• Project/Area Number: 26870220
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical pharmacy; Environmental and hygienic pharmacy
• Research Institution: Kanazawa University
• Principal Investigator: YOSHIDA Naoko 金沢大学, 薬学系, 助教 (20565428)
• Research Collaborator: SANADA Tomoko
• Project Period (FY): 2014-04-01 – 2016-03-31
• Project Status: Completed (Fiscal Year 2015)
• Budget Amount: ¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000); Fiscal Year 2015: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000); Fiscal Year 2014: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
• Keywords: 偽造医薬品 / 不純物プロファイル / 鑑別 / ラマン散乱

Outline of Final Research Achievements

I wished to improve the accuracy of detection of falsified medicines. Impurity analyses were undertaken to detect falsified samples of Cialis(R) and compared with other analytical methods. Out of 41 samples, all falsified samples of Cialis(R) (n=32) were defined as “falsified medicine” by impurity profiling. These falsified samples of Cialis(R) could be categorized broadly into seven types according to the nature and amount of ingredients. Physical appearance (color, size, weight), Raman spectra (obtained from the tablet surface) and near-infrared spectrum (obtained from the whole tablet) of falsified samples of Cialis(R) were different from authentic samples. These findings suggest that impurity profiling could be a useful method for detection of falsified medicines in pharmaceutical distribution.

Research Products

• [Presentation] インターネットを介して個人輸入されたシアリスの真正性と品質に関する研究 (2016)
  • Author(s): 眞田智子, 吉田直子, 坪井宏仁, 木村和子
  • Organizer: 日本薬学会第136年会
  • Place of Presentation: パシフィコ横浜（神奈川県横浜市）
  • Year and Date: 2016-03-29
• [Presentation] 途上国における医薬品事情 (2016)
  • Author(s): 吉田直子
  • Organizer: 日本国際保健医療学会第34回西日本地方会
  • Place of Presentation: 川崎医科大学現代医学教育博物館（岡山県倉敷市）
  • Year and Date: 2016-02-27
  • Invited
• [Presentation] 偽造医薬品の脅威と撲滅に向けた取り組み (2015)
  • Author(s): 吉田直子
  • Organizer: Hokuriku Women Researchers’ Network シンポジウム
  • Place of Presentation: 金沢歌劇座（石川県金沢市）
  • Year and Date: 2015-12-05
  • Invited
• [Presentation] OTC医薬品の安全性―忍び寄る偽造医薬品の脅威― (2015)
  • Author(s): 吉田直子
  • Organizer: 2015年度 日本OTC医薬品協会安全性情報部会
  • Place of Presentation: 金沢大学（石川県金沢市）
  • Year and Date: 2015-11-13
  • Invited
• [Presentation] 医薬品の品質管理に貢献する分析－偽造医薬品鑑別における分析手法の活用－ (2015)
  • Author(s): 吉田直子
  • Organizer: Matching HUB Kanazawa 2015
  • Place of Presentation: ANAクラウンプラザホテル金沢（石川県金沢市）
  • Year and Date: 2015-02-23
  • Invited