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A new formulation of Gamma Delta Tocotrienol has superior bioavailability compared to existing Tocotrienol-Rich Fraction in healthy human subjects.

Meganathan P, Jabir RS, Fuang HG, Bhoo-Pathy N, Choudhury RB, Taib NA, Nesaretnam K, Chik Z - Sci Rep (2015)

Bottom Line: The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05).GDT was found not bioequivalent to TRF, in terms of AUC and Cmax.Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.

ABSTRACT
Gamma and delta tocotrienols are isomers of Vitamin E with established potency in pre-clinical anti-cancer research. This single-dose, randomized, crossover study aimed to compare the safety and bioavailability of a new formulation of Gamma Delta Tocotrienol (GDT) in comparison with the existing Tocotrienol-rich Fraction (TRF) in terms of gamma and delta isomers in healthy volunteers. Subjects were given either two 300 mg GDT (450 mg γ-T3 and 150 mg δ-T3) capsules or four 200 mg TRF (451.2 mg γ-T3 &102.72 mg δ-T3) capsules and blood samples were taken at several time points over 24 hours. Plasma tocotrienol concentrations were determined using HPLC method. The 90% CI for gamma and delta tocotrienols for the ratio of log-transformation of GDT/TRF for Cmax and AUC0-∞ (values were anti-logged and expressed as a percentage) were beyond the bioequivalence limits (106.21-195.46, 154.11-195.93 and 52.35-99.66, 74.82-89.44 respectively). The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05). No adverse events were reported during the entire period of study. GDT was found not bioequivalent to TRF, in terms of AUC and Cmax. Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.

No MeSH data available.


Related in: MedlinePlus

Chromatogram of gamma delta tocotrienols and internal standard in plasma.
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f1: Chromatogram of gamma delta tocotrienols and internal standard in plasma.

Mentions: The recovery of gamma tocotrienol ranged from 87.38% to 90.79% and it was between 81.39% to 90.33% for delta tocotrienol. Calibration curves of analytes spiked in plasma were linear with R2 > 0.990 from 1 μg/mL to 25 μg/mL. The concentrations of quality controls of gamma and delta tocotrienols used were 3 μg/mL, 13 μg/mL and 23 μg/mL as low, medium and high quality controls respectively. The coeffiecient of variation (CV) of intraday and interday ranged from 1.06 to 3.47 for gamma tocotrienol while it was from 0.66 to 5.19 for delta tocotrienol. Meanwhile, accuracy percentage values for gamma and delta tocotrienols ranged from 95.32% to 108.30% and 95.81% to 110.14% respectively. Both gamma and delta tocotrienols were also found to be stable after three freeze-thaw cycles. Figures 1 and 2 show chromatograms of gamma and delta tocotrienols prepared in plasma and solvent respectively.


A new formulation of Gamma Delta Tocotrienol has superior bioavailability compared to existing Tocotrienol-Rich Fraction in healthy human subjects.

Meganathan P, Jabir RS, Fuang HG, Bhoo-Pathy N, Choudhury RB, Taib NA, Nesaretnam K, Chik Z - Sci Rep (2015)

Chromatogram of gamma delta tocotrienols and internal standard in plasma.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4555096&req=5

f1: Chromatogram of gamma delta tocotrienols and internal standard in plasma.
Mentions: The recovery of gamma tocotrienol ranged from 87.38% to 90.79% and it was between 81.39% to 90.33% for delta tocotrienol. Calibration curves of analytes spiked in plasma were linear with R2 > 0.990 from 1 μg/mL to 25 μg/mL. The concentrations of quality controls of gamma and delta tocotrienols used were 3 μg/mL, 13 μg/mL and 23 μg/mL as low, medium and high quality controls respectively. The coeffiecient of variation (CV) of intraday and interday ranged from 1.06 to 3.47 for gamma tocotrienol while it was from 0.66 to 5.19 for delta tocotrienol. Meanwhile, accuracy percentage values for gamma and delta tocotrienols ranged from 95.32% to 108.30% and 95.81% to 110.14% respectively. Both gamma and delta tocotrienols were also found to be stable after three freeze-thaw cycles. Figures 1 and 2 show chromatograms of gamma and delta tocotrienols prepared in plasma and solvent respectively.

Bottom Line: The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05).GDT was found not bioequivalent to TRF, in terms of AUC and Cmax.Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.

ABSTRACT
Gamma and delta tocotrienols are isomers of Vitamin E with established potency in pre-clinical anti-cancer research. This single-dose, randomized, crossover study aimed to compare the safety and bioavailability of a new formulation of Gamma Delta Tocotrienol (GDT) in comparison with the existing Tocotrienol-rich Fraction (TRF) in terms of gamma and delta isomers in healthy volunteers. Subjects were given either two 300 mg GDT (450 mg γ-T3 and 150 mg δ-T3) capsules or four 200 mg TRF (451.2 mg γ-T3 &102.72 mg δ-T3) capsules and blood samples were taken at several time points over 24 hours. Plasma tocotrienol concentrations were determined using HPLC method. The 90% CI for gamma and delta tocotrienols for the ratio of log-transformation of GDT/TRF for Cmax and AUC0-∞ (values were anti-logged and expressed as a percentage) were beyond the bioequivalence limits (106.21-195.46, 154.11-195.93 and 52.35-99.66, 74.82-89.44 respectively). The Wilcoxon Signed Rank Test for Tmax did not show any significant difference between GDT and TRF for both isomers (p > 0.05). No adverse events were reported during the entire period of study. GDT was found not bioequivalent to TRF, in terms of AUC and Cmax. Gamma tocotrienol in GDT showed superior bioavailability whilst delta tocotrienol showed less bioavailability compared to TRF.

No MeSH data available.


Related in: MedlinePlus