Bioavailability Study of Maxicuma Capsules Versus Micronized Curcumin Capsules as A Single Oral Dose in Fasted Healthy Adult Human Subjects

Aim: The purpose of this study is to evaluate and compare the amount of free Curcumin in the human blood plasma after administration of three Capsules of Maxicuma 500 mg and three Capsules of Micronized Curcumin 95% each 500 mg as single dose in fasted healthy adult human subjects. The results of the study are also compared with plasma concentration of free Curcumin by Standard Curcumin as reported in the literature [17]. Methodology: Comparative bioavailability of free curcumin for three Capsules of Maxicuma 500 mg and three Capsules of Micronized Curcumin 95%, (500) mg was evaluated in an open label, non-randomized, two-treatment, two-period, two-group crossover study after single oral dose administration in 14 fasted healthy adult humans. The free Curcumin was determined along with pharmacokinetic parameters such as Cmax, AUC0-t, T1/2, Ke, Tmax, %AUC extra, n points, Ke_first and Ke_last. Linear & Semi log graphs were plotted with the help of SASR ® . In addition, the total Curcuminoids (Comprising Curcumin, Bis-Demethoxy curcumin, Demethoxy curcumin & Tetra hydrocurcumin) after reaction with mixture of glucuronidas3 + sulphatase enzyme was estimated in plasma using validated LC-MS-MS method. Results: Data from the study reveals that the maximum measured plasma concentration of free Curcumin was 195.196 ng/mL for Maxicuma and 81.270 ng/mL for Micronized Curcumin 95%. The times where maximum plasma concentration of free Curcumin achieved for the Maxicuma and Micronized Curcumin 95%, were 3.129 hours and 4.750 hours respectively. Conclusion: Maxicuma composition was 3.11 fold more bioavailable, in terms of free Curcumin level, as compared to Micronized Curcumin 95%. As it is known from the literature that, micronization enhances the bioavailability by 9 folds, one can conclude that Maxicuma was 66.47(3.11/0.4 x 0.95 x 9) times more bioavailable in terms of total Curcuminoids compared to Standard Curcumin extract powder 95% and based on the literature study, provides 172 times more bioactive free Curcumin when compared to Standard Curcumin 95%.