A nanoparticle CBD oro-buccal spray achieved plasma concentrations comparable to other commercial formulations with no adverse effects in a small randomized trial of 16 healthy participants.
CBD researchers, pharmaceutical formulators, and clinicians interested in cannabinoid delivery methods.
Peak CBD concentration reached at 60 minutes via oral spray
What the researchers found
The nanoparticle CBD spray met primary outcomes for safety, tolerability, and pharmacokinetics. Peak CBD concentration occurred at 60 minutes for both 6 mg and 18 mg doses. Half-life was 1.23 hours for the low dose and 5.45 hours for the high dose. No adverse inflammatory effects were reported.
Why it matters
Oro-buccal delivery with nanoparticle technology could improve CBD bioavailability and onset time compared to traditional oral formulations.
The numbers in context
Participants: 16 (12 CBD, 4 placebo). Doses: 6 mg and 18 mg CBD. Peak time: 60 min for both doses. Half-life: 1.23 h (6 mg), 5.45 h (18 mg). AUC: 0.87 ng h/mL (6 mg), 8.9 ng h/mL (18 mg). THC per high dose: 0.72 mg.
How the study worked
Randomized, single-blinded, placebo-controlled pilot study. 12 participants received CBD spray (2 sprays on day 1, 6 sprays on day 2) and 4 received placebo, administered to alternating cheeks. Blood samples collected for pharmacokinetic profiling.
What this study cannot tell us
Very small sample (n=16). Single-blinded rather than double-blinded. Only healthy participants, no disease population. Short two-day dosing period.
How to read the evidence
Randomized and placebo-controlled but very small sample and short duration.
When this study was published
Published in 2021.
The bigger picture
CBD delivery technology continues to evolve, with nanoparticle formulations representing one approach to improving the notoriously poor oral bioavailability of cannabinoids.
Questions still open
- How does this nanoparticle formulation compare head-to-head with standard CBD oil? Would repeated dosing change the pharmacokinetic profile?
Common questions
What is a nanoparticle CBD formulation?
How fast does the oral spray work?
Read the original research
A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.
Inflammopharmacology, 29(5), 1361-1370
Citation
Vitetta, Luis; Butcher, Belinda; Henson, Jeremy D; Rutolo, David; Hall, Sean. (2021). A pilot safety, tolerability and pharmacokinetic study of an oro-buccal administered cannabidiol-dominant anti-inflammatory formulation in healthy individuals: a randomized placebo-controlled single-blinded study.. Inflammopharmacology, 29(5), 1361-1370. https://doi.org/10.1007/s10787-021-00859-y
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