Pharmaceutical and therapeutic equivalence study of the generic medicine containing loxoprofen sodium

Susumu Kaneshige, Satoru Koyanagi, Mami Kobayashi, Shigehiro Ohdo, Naoya Matsunaga, Hidetoshi Kamimura

Research output: Contribution to journalArticle

Abstract

Objectives: The use of generic medicines is generally recommended for reducing medical costs. However, many doctors and pharmacists do not trust the quality, efficacy and safety of some generic medicines. Loxonin® containing loxoprofen sodium is widely used as an antipyretics analgesic, and Lobu® is the generic form of Loxonin® The pharmaceutical and therapeutic equivalence of Lobu® was compared to Loxonin® Methods: The dissolution rate of loxoprofen sodium from Lobu® was compared to that of Loxonin®. In addition, clinical data of the patients treated with Lobu® in Fukuoka Memorial Hospital was compared to those treated with Loxonin® in Fukuoka University Chikushi Hospital. The number of patients treated with Lobu® and Loxonin® was 76 and 79, and the mean age was 45.8 years old and 47.5 years old, respectively. Results: Lobu® did not meet the standard of the dissolution test of loxoprofen sodium at a pH of 1.2. However, the analgesic effect of Lobu® on patients undergone orthopedic surgery was equal to that of Loxonin®. In addition, severe hematopoietic injury, hepatic dysfunction, or renal dysfunction were not observed during Lobu® treatment. Conclusions: Although Lobu® is not 100% pharmaceutically equivalent to Loxonin® the efficacy and safety are considered to be equivalent to Loxonin®.

Original languageEnglish
Pages (from-to)1081-1088
Number of pages8
JournalJapanese Pharmacology and Therapeutics
Volume40
Issue number12
Publication statusPublished - Dec 1 2012

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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