Abstract

Objective: Theracurmin, which contains the curcumin composition, CR-033P, has been demonstrated to be highly bioavailable. To compare the pharmacokinetics of the three compositions, CR-033P, CR-043P using modified starch as an alternative to the dispersant gum ghatti used in the CR-033P, and TS-P1 containing the newly developed amorphous curcumin, a randomized double-blind crossover study (3-way, 3-period) was conducted.
Materials and methods: A single dose of the curcumin capsules (TS-P1 45 mg, CR-033P 90 mg, and CR-043P 90 mg) was administered to healthy adult participants. Blood sampling was performed 24 hours after capsule administration, and the plasma concentration of total curcumin was determined using high-performance liquid chromatography coupled with tandem mass spectrometry.
Results: TS-P1 and CR-043P tended to have a slightly lower area under the concentration time curve (AUC) _0–24h than CR-033P, while TS-P1 displayed bioequivalence to CR-043P. Further, TS-P1 displayed bioequivalence to CR-033P in terms of AUC_0–12h, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC_0–12h than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of C_max. TS-P1 tended to have a higher C_max than CR-033P, CR-043P tended to have a slightly lower C_max than CR-033P, and TS-P1 tended to have a higher C_max than CR-043P.
Conclusion: The newly developed TS-P1 composition seemed to display similar curcumin systemic exposure except for a higher plasma concentration than the CR-033P composition. Further, only a few significant differences were found between CR-043P and CR-033P.

Author Details

Authors

• Akiko Hirose¹
• Yoshitaka Kuwabara¹
• Yoko Kanai²
• Chieko Kato³
• Yuji Makino³
• Fukumoto Yoshi⁴
• Kazumoto Sasaki⁴

Departments

• ¹ Department of R&D, Theravalues Corp.,
• ² CRO Business Div., Apo Plus Station Co. Ltd.,
• ³ Institute for Pharmaceutical Research, Musashino University, Tokyo, and
• ⁴ Sasaki Memorial Hospital, Tokorozawa, Saitama, Japan

Address

Akiko Hirose, Research fellow
Department of R&D, Theravalues Corp.
1F Kioicho Bldg. 3-12 Kioicho chiyoda-ku
Tokyo 102-0094, Japan
Email: [email protected]

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