The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers
The present study aimed to determine the pharmacokinetic parameters and bioavailability of silymarin 140 mg SMEDDS formulation. An open-label, single-dose pharmacokinetic study was conducted. Twelve healthy volunteers were included in the study. After the volunteers had fasted overnight for 10 h, a...
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2018-01-01
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doaj-f84279dc778545df8ae2f7e1b3a033832020-11-25T00:58:03ZengHindawi LimitedEvidence-Based Complementary and Alternative Medicine1741-427X1741-42882018-01-01201810.1155/2018/15078341507834The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai VolunteersChuleegone Sornsuvit0Darunee Hongwiset1Songwut Yotsawimonwat2Manatchaya Toonkum3Satawat Thongsawat4Wandee Taesotikul5Pharmacy Service Center, Pharmacy Faculty, Chiang Mai University, Chiang Mai 50200, ThailandPharmacy Service Center, Pharmacy Faculty, Chiang Mai University, Chiang Mai 50200, ThailandPharmacy Service Center, Pharmacy Faculty, Chiang Mai University, Chiang Mai 50200, ThailandPharmacy Service Center, Pharmacy Faculty, Chiang Mai University, Chiang Mai 50200, ThailandDepartment of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, ThailandPharmacy Service Center, Pharmacy Faculty, Chiang Mai University, Chiang Mai 50200, ThailandThe present study aimed to determine the pharmacokinetic parameters and bioavailability of silymarin 140 mg SMEDDS formulation. An open-label, single-dose pharmacokinetic study was conducted. Twelve healthy volunteers were included in the study. After the volunteers had fasted overnight for 10 h, a single-dose generic silymarin 140 mg SMEDDS soft capsule was administered. Then 10 ml blood samples were taken at 0.0, 0.25, 0.50, 0.75, 1.0, 1.33, 1.67, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 h. The plasma silybin concentrations were analyzed using validated LC-MS/MS. The pharmacokinetic parameters were analyzed and calculated. The pharmacokinetic parameters were calculated after silymarin had been administered as a single capsule. The mean (range) Cmax was 812.43 (259.47–1505.47) ng/ml at 0.80 (0.25–1.67) h (tmax). The mean (range) AUC0-t and AUC0-inf were 658.80 (268.29–1045.01) ng.h/ml and 676.98 (274.10–1050.96) ng.h/ml, respectively. The mean ke and t1/2 were 0.5386 h-1 and 1.91 h, respectively. The silymarin SMEDDS formulation soft capsule showed rapid absorption and high oral bioavailability.http://dx.doi.org/10.1155/2018/1507834 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Chuleegone Sornsuvit Darunee Hongwiset Songwut Yotsawimonwat Manatchaya Toonkum Satawat Thongsawat Wandee Taesotikul |
spellingShingle |
Chuleegone Sornsuvit Darunee Hongwiset Songwut Yotsawimonwat Manatchaya Toonkum Satawat Thongsawat Wandee Taesotikul The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers Evidence-Based Complementary and Alternative Medicine |
author_facet |
Chuleegone Sornsuvit Darunee Hongwiset Songwut Yotsawimonwat Manatchaya Toonkum Satawat Thongsawat Wandee Taesotikul |
author_sort |
Chuleegone Sornsuvit |
title |
The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers |
title_short |
The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers |
title_full |
The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers |
title_fullStr |
The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers |
title_full_unstemmed |
The Bioavailability and Pharmacokinetics of Silymarin SMEDDS Formulation Study in Healthy Thai Volunteers |
title_sort |
bioavailability and pharmacokinetics of silymarin smedds formulation study in healthy thai volunteers |
publisher |
Hindawi Limited |
series |
Evidence-Based Complementary and Alternative Medicine |
issn |
1741-427X 1741-4288 |
publishDate |
2018-01-01 |
description |
The present study aimed to determine the pharmacokinetic parameters and bioavailability of silymarin 140 mg SMEDDS formulation. An open-label, single-dose pharmacokinetic study was conducted. Twelve healthy volunteers were included in the study. After the volunteers had fasted overnight for 10 h, a single-dose generic silymarin 140 mg SMEDDS soft capsule was administered. Then 10 ml blood samples were taken at 0.0, 0.25, 0.50, 0.75, 1.0, 1.33, 1.67, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 h. The plasma silybin concentrations were analyzed using validated LC-MS/MS. The pharmacokinetic parameters were analyzed and calculated. The pharmacokinetic parameters were calculated after silymarin had been administered as a single capsule. The mean (range) Cmax was 812.43 (259.47–1505.47) ng/ml at 0.80 (0.25–1.67) h (tmax). The mean (range) AUC0-t and AUC0-inf were 658.80 (268.29–1045.01) ng.h/ml and 676.98 (274.10–1050.96) ng.h/ml, respectively. The mean ke and t1/2 were 0.5386 h-1 and 1.91 h, respectively. The silymarin SMEDDS formulation soft capsule showed rapid absorption and high oral bioavailability. |
url |
http://dx.doi.org/10.1155/2018/1507834 |
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