Comparison of Chemical Behavior of Original and Generic Docetaxel Formulations as Non-alcoholic Preparations: Discussion about Diluent Solvents for Docetaxel

• Ogawa Chiaki

  Department of Pharmacy, National Hospital Organization Tokyo Medical Center Laboratory of Pharmaceutics, Kitasato University School of Pharmacy

• Yatabe Megumi

  Department of Pharmacy, National Hospital Organization Tokyo Medical Center

• Inoue Motoki

  Meiji Pharmaceutical University

• Hirose Shoko

  Department of Pharmacy, National Hospital Organization Tokyo Medical Center

• Ohashi Yasukata

  Department of Pharmacy, National Hospital Organization Tokyo Medical Center

• Yachi Yutaka

  Department of Pharmacy, National Hospital Organization Tokyo Medical Center

• Adachi Shigeru

  Meiji Pharmaceutical University

• Itoh Tomoo

  Laboratory of Pharmaceutics, Kitasato University School of Pharmacy

Abstract

　Although generic anti-tumor agents are in wide clinical use, they have not in all cases been shown to be equivalent to the original agents after preparation. In the present study, original and generic docetaxel formulations were compared with respect to stability when prepared as a non-alcoholic solution for use. When the original formulation was diluted with physiological saline solution to make a non-alcoholic preparation, the concentration decreased with time, whereas no such decrease occurred when a preparation of the generic formulation was made in a similar manner. With both the original and generic formulations, no decrease in docetaxel concentration with time was found after dilution with 5% glucose solution. On the basis of these results, it is concluded that the behaviors of original and generic docetaxel formulations are not equivalent when prepared, but that the original and generic formulations can be taken to be equivalent if they are diluted with 5% glucose solution at preparation.<br>

Journal

• YAKUGAKU ZASSHI

  YAKUGAKU ZASSHI 138 (7), 973-984, 2018-07-01

  The Pharmaceutical Society of Japan

Keywords

• docetaxel
• stability
• diluent solvent
• generic
• non-alcoholic docetaxel
• micelle

Details

• CRID: 1390845712993480576
• NII Article ID: 130007386632
• NII Book ID: AN00284903
• DOI: 10.1248/yakushi.18-00006
• ISSN: 13475231
• ISSN: 00316903
• NDL BIB ID: 029150383
• PubMed: 29962477
• Web Site: http://id.ndl.go.jp/bib/029150383
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I029150383
• Web Site: https://www.jstage.jst.go.jp/article/yakushi/138/7/138_18-00006/_pdf
• Text Lang: ja
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed