A pilot cross-over study to evaluate human oral bioavailability of BCM-95^®CG (Biocurcumax^TM), a novel bioenhanced preparation of curcumin

Abstract

Curcumin, the bioactive component of turmeric, Curcuma longa has an exceptionally wide spectrum of activities including antioxidant, anti-inflammatory and anti-cancer properties, and is currently under different phases of clinical trials for various types of soft tissue cancers. However, although in vitro and animal studies have shown anticancer activities of curcumin for virtually all types of human cancers, its poor bioavailability in the human body has severely limited its application to these diseases. Methods to increase its oral bioavailability are a subject of intense current research. Reconstituting curcumin with the non-curcuminoid components of turmeric has been found to increase the bioavailability substantially. In the present clinical study to determine the bioavailability of curcuminoids, a patented formulation, BCM-95®CG was tested on human volunteer group. Normal curcumin was used in the control group. Curcumin content in blood was estimated at periodical intervals. After a washout period of two weeks the control group and drug group were crossed over BCM-95®CG and curcumin, respectively. It was also compared with a combination of curcumin-lecithin-piperine which was earlier shown to provide enhanced bioavailability. The results of the study indicate that the relative bioavailability of BCM-95®CG (Biocurcumax™) was about 6.93-fold compared to normal curcumin and about 6.3-fold compared to curcumin-lecithin-piperine formula. BCM-95®CG thus, has potential for widespread application for various chronic diseases.

Colloidal Submicron-Particle Curcumin Exhibits High Absorption Efficiency—A Double-Blind, 3-Way Crossover Study—

“…So, in this study, volunteers were administered with 180 mg of Theracurmin. From 1 to 8 capsules (approximately 260-2,080 mg of curcumin) BCM-95 were used for clinical trials (20,28,32,41). Since even 1 capsule had benefi cial effects on patients with RA, we used 1 capsule (260 mg of curcumin) in this study to adjust the curcumin level in all groups.…”

“…One of these curcumin formulations is BCM-95, generated by micronizing curcumin and adding turmeric essential oils to enhance absorption naturally. The relative bioavailability of BCM-95 was found to be about 6.9-fold higher than that of normal curcumin in humans (20). Another lecithinized formulation of curcumin, Meriva, was tested in healthy volunteers, and found to improve absorption to about a 29-fold higher level than corresponding normal curcumin (21).…”

The Potential Role of Curcumin for Treatment of Pancreatic Cancer

“…Thus, poor bioavailability is the major weak point of curcumin and has been the main challenge for physicians seeking to verify the therapeutic efficacy of this promising agent in clinical trials. Therefore, many efforts have been made to improve its bioavailability through several approaches including innovative drug delivery systems (liposomes, nanoparticles and phospholipids) (Anand et al, 2010;Antony et al, 2008;Bisht et al, 2007;Das et al, 2010;Gupta et al, 2009;Koppolu et al, 2010;Li et al, 2005;Liu et al, 2006;Marczylo et al, 2007;Mukerjee & Vishwanatha, 2009;Sahu et al, 2008;Shaikh et al, 2009;Sou et al, 2008;Takahashi et al, 2009), or the development of new curcumin analogues Mosley et al, 2007;Ohori et al, 2006;Sato et al, 2011). A nanoparticlebased drug delivery system is effective in improving the water solubility of hydrophobic agents like curcumin, and the development of at least 8 different types of nanoparticlebased curcumin have been published up to this point (Anand et al, 2010;Bisht et al, 2007; Das et al, 2010;Gupta et al, 2009;Mukerjee & Vishwanatha, 2009;Shaikh et al, 2009;Sou et al, 2008).…”

Interaction of curcumin nanoformulations with human plasma proteins and erythrocytes

“…12,14,15 Recently, several curcumin nanoformulations, such as polymer nanoparticles, selfassemblies, nanocrystal dispersions, nanoemulsions, lipid nanoparticles, and protein-based drug delivery systems, have shown improved solubility, stability, and bioavailability of the curcumin molecule. [14][15][16][17][18][19][20] Moreover, curcumin nanoformulations have demonstrated improved cellular uptake in cancer models that increases the chance of a positive therapeutic outcome. Curcumin nanoformulations have also exhibited superior in vitro anticancer responses compared with free curcumin due to sustained release of the active compound and the enhanced permeation and retention effects of nanoformulations.…”