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Study breakdown

Nanoparticle CBD oral spray was safe and well-tolerated in a small pilot trial

Randomized Controlled TrialPreliminary evidence
The takeaway

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?
A water-soluble form of CBD created using micellular technology to produce very small particles, potentially improving absorption compared to oil-based CBD products.
How fast does the oral spray work?
CBD reached peak plasma concentration at 60 minutes for both the low (6 mg) and high (18 mg) doses when sprayed inside the cheek.

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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