Houston, Texas, Oct. 12, 2016–Unibar Corp. announced the identification of a new micronized form of curcumin that has better absorption and is devoid of toxicity. To improve bioavailability and maintain purity, the particle size of its new branded ingredient CQUMIN™ (c-q-min), is reduced to 350nm and is highly water dispersible for beverage and food applications.
Unibar Corp. has conducted and completed a double-blind, open label, randomized, balanced, single-period, two-treatment, parallel, single-dose oral bioequivalence study of CQUMIN™ curcumin vegetarian capsules to compare with curcumin vegetarian capsules in 12 healthy adult male subjects under fasting conditions.
The study, conducted at Notrox Research in Bangalore, India, included healthy adult human subjects between 18-45 years (both inclusive) of age, having a Body Mass Index (BMI) between 18.50 – 24.99 Kg/m2 (both inclusive), healthy according to medical history, clinical examination, laboratory evaluations, 12-lead electrocardiogram recordings and chest X-ray.
Pure curcuminoids standards were provided from Chromadex, based in Irvine, CA. Beta-Glucuronidase from Escherichia coli, Type IX-A and Sulfatase from Helix pomatia, Type H-1 enzymes were provided from Sigma-Aldrich, Bangalore, India. The CQUMIN™ capsules and standard capsules, were manufactured by Unibar Corp., and standard curcumin supplied by Synthite Industries Ltd., of Kerala, India. The vegetarian capsules were provided by Capsugel of India.
The dose consisted of 12g (19 vegetarian capsules containing 635mg of curcuminoids each) of either CQUMIN™ or standard curcumin as per the randomization schedule in fasting state for at least 10 hours before scheduled time.
Sampling schedule included a single pre-dose (0.00) blood sample of 6.0 ml and the post-dose blood samples of 6.0 ml each collected at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 12.00, 18.00 and 24.00 hours.
The blood plasma samples were evaluated for Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin and Tetrahydrocurcumin by tandem mass spectrometry detection (HPLC/MS/MS).
Free curcuminoids could not be detected in any plasma samples, in accordance with previous studies that have mostly failed to detect free curcumin in human plasma even after the administration of higher doses of curcumin. All plasma samples are hydrolyzed with beta-Glucuronidase from Escherichia coli, Type IX-A and Sulfatase from Helix pomatia, Type H-1 enzymes and converted into free curcuminoids (C1, C2, C3 and THC) and later analyzed by HPLC-MS/MS. The 12g dose is well tolerated in all subjects.
According to Sevanti Mehta, president of Unibar Corp., many bioavailable formulations of curcumin have significantly high amounts of additives. Further, the curcumin content in the current marketplace bioavailable formulations are very low, ranging from 10-20 percent except one which is standardized for 80 percent curcumin and formulated with essential oils.
A recent NutraIngredients-USA article noted that bioavailability is just one factor. Pharmacokinetics (blood level) and Pharmacodynamics (clinical effects) cannot be correlated due to extensive bio transformation of curcumin in the intestine and liver.
“Unibar’s aim is to increase the curcumin absorption in the body and at the same time maintain purity,” said Mehta. “Specifically, there should be no toxicity effects and be devoid of significant amounts of additives. CQUMIN has no additives. In addition, CQUMIN™ is standardized to contain 90 to 95 percent Curcumin.”
“Size does matter. In general, the smaller particle size has quicker absorption in the body. The particle size of currently available as high pure Curcumin 95 percent and is roughly about 40 mesh.”
In conclusion, pharmacokinetic data for each administration were graphed, and statistical analysis was performed. The average of each group’s plasma analyte concentration was plotted against time.
From the study data, the average absorption of curcumin is calculated to be ca. 3.5-times higher from CQUMIN™ than from the corresponding standard curcuminoids. Similarly, the average absorption for demethoxycurcumin, Bisdemethoxycurcumin and tetrahydrocurcumin (THC) are 8.14-times, 10.52-times, 2.29-times respectively higher from CQUMIN™ than from the standard curcuminoids.
For more information, contact Unibar Corporation at (832)567-8500 or via email at SevantiMehta@UnibarCorp.com.