{"title":"姜黄素新制剂的比较药代动力学和提高健康成人生物利用度的证据。","authors":"Akiko Hirose, Yoshitaka Kuwabara, Yoko Kanai, Chieko Kato, Yuji Makino, Fukumoto Yoshi, Kazumoto Sasaki","doi":"10.5414/CP204257","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>TS-P1 and CR-043P tended to have a slightly lower area under the concentration time curve (AUC) <sub>0-24h</sub> than CR-033P, while TS-P1 displayed bioequivalence to CR-043P. Further, TS-P1 displayed bioequivalence to CR-033P in terms of AUC<sub>0-12h</sub>, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC<sub>0-12h</sub> than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of C<sub>max</sub>. TS-P1 tended to have a higher C<sub>max</sub> than CR-033P, CR-043P tended to have a slightly lower C<sub>max</sub> than CR-033P, and TS-P1 tended to have a higher C<sub>max</sub> than CR-043P.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"60 12","pages":"530-538"},"PeriodicalIF":0.9000,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685553/pdf/","citationCount":"1","resultStr":"{\"title\":\"Comparative pharmacokinetics of new curcumin preparations and evidence for increased bioavailability in healthy adult participants.\",\"authors\":\"Akiko Hirose, Yoshitaka Kuwabara, Yoko Kanai, Chieko Kato, Yuji Makino, Fukumoto Yoshi, Kazumoto Sasaki\",\"doi\":\"10.5414/CP204257\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>TS-P1 and CR-043P tended to have a slightly lower area under the concentration time curve (AUC) <sub>0-24h</sub> than CR-033P, while TS-P1 displayed bioequivalence to CR-043P. Further, TS-P1 displayed bioequivalence to CR-033P in terms of AUC<sub>0-12h</sub>, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC<sub>0-12h</sub> than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of C<sub>max</sub>. TS-P1 tended to have a higher C<sub>max</sub> than CR-033P, CR-043P tended to have a slightly lower C<sub>max</sub> than CR-033P, and TS-P1 tended to have a higher C<sub>max</sub> than CR-043P.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":13963,\"journal\":{\"name\":\"International journal of clinical pharmacology and therapeutics\",\"volume\":\"60 12\",\"pages\":\"530-538\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2022-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9685553/pdf/\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International journal of clinical pharmacology and therapeutics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.5414/CP204257\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International journal of clinical pharmacology and therapeutics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.5414/CP204257","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Comparative pharmacokinetics of new curcumin preparations and evidence for increased bioavailability in healthy adult participants.
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 AUC0-12h, while that of CR-043P tended to be lower than that of CR-033P. TS-P1 had a higher AUC0-12h than CR-043P. A statistically significant difference (p < 0.001) was found between the preparations in terms of Cmax. TS-P1 tended to have a higher Cmax than CR-033P, CR-043P tended to have a slightly lower Cmax than CR-033P, and TS-P1 tended to have a higher Cmax 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.
期刊介绍:
The International Journal of Clinical Pharmacology and Therapeutics appears monthly and publishes manuscripts containing original material with emphasis on the following topics: Clinical trials, Pharmacoepidemiology - Pharmacovigilance, Pharmacodynamics, Drug disposition and Pharmacokinetics, Quality assurance, Pharmacogenetics, Biotechnological drugs such as cytokines and recombinant antibiotics. Case reports on adverse reactions are also of interest.