Affiliations: Research Institute of Pharmaceutical Sciences, Musashino University, Shinmachi 1-1-20, Nishi-Tokyo 202-8585, Japan | Kobe Pharmaceutical University, Motoyama-Kitamchi 4-19-1, Higashi-Nada, Kobe 658-8558, Japan | School of Medicine, Showa University, Hatanodai 1-5-8, Shinagawa, Tokyo 142-8555, Japan | Graduate School of Medicine, Kobe University, Kusunokichou 7-5-1, Chuo, Kobe 650-0017, Japan | University Hospital Pharmacy, University of Utah, 50 North Medical Drive, Salt Lake City, UT 84132, USA
Note: [] Corresponding author: Makoto Otsuka, PhD, Research Institute of Pharmaceutical Sciences, Musashino University, Shinmachi, Nishi-Tokyo 202-8585, Japan. Tel./Fax: +81 424 68 8658; E-mail: [email protected].
Abstract: Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0±0.5°C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.
Keywords: Ibuprofen tablets, automatic-dissolution test, generic drug, international harmonization
