Pharmacokinetic evaluation of a novel CBD capsule formulation (CBDNext Supra) versus conventional CBD delivery
Journal of Cannabis Research (2025) 7:e00312 · DOI 10.1186/s42238-025-00312-9
- CBDNext Supra Capsule
- 40 mg CBD isolate
- Healthy adult volunteers
- Randomized, three-way crossover, single-dose
- 72-hour PK sampling per period
- Cmax, AUC₀₋₇₂, Tmax, inter-subject variability
5.7× higher Cmax; 3.3× greater AUC₀₋₇₂; faster Tmax; significantly lower variability (CV%)
Background: Cannabidiol (CBD) is a non-psychoactive phytocannabinoid with growing interest for health and wellness applications. However, oral CBD bioavailability is limited by poor aqueous solubility and extensive first-pass metabolism. This study evaluated two novel CBD formulations developed using Micro Matrix Technology against a standard CBD isolate reference.
Methods: A randomized, single-dose, three-way crossover study was conducted in 9 healthy adult volunteers under fed (low-fat) conditions. Subjects received 40 mg CBD as: (1) CBDNext Supra Capsule (solid matrix formulation with polysorbate 80, maltodextrin, stearic acid, silica derivative), (2) CBDNext Supra Liquid (liquid formulation), or (3) Reference capsule (CBD isolate with microcrystalline cellulose). Blood samples were collected over 72 hours. Plasma CBD and 7-hydroxy-CBD concentrations were measured by validated LC-MS/MS.
Results — CBD Pharmacokinetics: • Supra Capsule: Cmax 14.1 ng/mL, AUC₀₋₇₂ 38.0 h·ng/mL, median Tmax 2.0 h, CV% ~27% • Supra Liquid: Cmax 6.20 ng/mL, AUC₀₋₇₂ 20.2 h·ng/mL, median Tmax 1.0 h, CV% ~44% • Reference: Cmax 2.44 ng/mL, AUC₀₋₇₂ 11.7 h·ng/mL, median Tmax 6.0 h, CV% ~134%
Geometric Mean Ratios (90% CI): • Capsule vs Reference — Cmax: 566% (356–900%), AUC: 328% (226–478%) • Liquid vs Reference — Cmax: 248% (156–394%), AUC: 166% (114–241%) • Capsule vs Liquid — Cmax: 229% (140–374%), AUC: 198% (136–288%)
7-Hydroxy-CBD Metabolite: • Capsule: Cmax 1.8 ng/mL, AUC 8.0 h·ng/mL • Liquid: Cmax 1.0 ng/mL, AUC 4.5 h·ng/mL • Reference: Cmax 0.4 ng/mL, AUC 1.8 h·ng/mL
Safety: No serious adverse events were reported. The only treatment-related adverse event was mild-to-moderate transient headache in 4 subjects. No clinically significant changes in liver function tests. Plasma cortisol remained within normal ranges throughout all study periods.
Conclusions: The CBDNext Supra Capsule formulation demonstrated substantially enhanced CBD bioavailability compared to standard CBD isolate, with approximately 5.7-fold higher peak plasma concentration and 3.3-fold greater total exposure. Both novel formulations showed markedly reduced inter-subject variability, suggesting more predictable and consistent CBD delivery. The solid matrix formulation (Supra Capsule) outperformed the liquid formulation across all pharmacokinetic parameters.
Authors: Pisak MN, Bereket E, Erenmemisoglu A Published: Journal of Cannabis Research, Volume 7, Article 54 (2025) Publisher: Springer Nature / BioMed Central