CBD sublingual wafer achieved comparable blood levels to oil and nabiximols spray | Research

The takeaway

In 12 healthy volunteers, a CBD sublingual wafer delivered equivalent CBD concentrations to oil solution and nabiximols spray, with mild side effects including drowsiness and mood changes.

Pharmacologists, CBD formulation developers, and clinicians comparing CBD delivery methods.

Sublingual wafer and oil achieved equivalent CBD bioavailability

What the researchers found

CBD sublingual wafer bioavailability was comparable to oil solution (90% CI: 83-131%). Median peak CBD concentrations were 11.9 ng/mL (wafer) and 9.4 ng/mL (oil). Peak concentrations occurred 4 hours after administration with an elimination half-life of approximately 6 hours. No significant difference in total CBD exposure between wafer, oil, and nabiximols spray. Adverse events included mild somnolence, sedation, and altered mood.

Why it matters

CBD delivery format matters for patients. A sublingual wafer could offer advantages in dosing precision and convenience compared to oil or spray formulations. This study establishes that the wafer format does not sacrifice bioavailability.

The numbers in context

12 volunteers. Wafer peak CBD: 11.9 ng/mL. Oil peak CBD: 9.4 ng/mL. Time to peak: 4 hours. Half-life: ~6 hours. Relative bioavailability wafer vs. oil: 83-131% (90% CI). Multiple-dose: 50 mg twice daily for 5 days.

How the study worked

Phase I open-label, 4-way crossover trial in 12 healthy volunteers. Single doses of CBD sublingual wafer (25 or 50 mg), oil solution (50 mg), or nabiximols spray (20 mg CBD + 21.6 mg THC) administered in randomized sequence. Multiple-dose arm: 50 mg wafer twice daily for 5 days.

What this study cannot tell us

Very small sample (12 volunteers). Healthy volunteers only. Single-dose primary assessment. Open-label design. Cannabis extract composition may vary between products.

How to read the evidence

Very small Phase I study in healthy volunteers. Preliminary pharmacokinetic data only.

When this study was published

2021 Phase I pharmacokinetic study.

The bigger picture

As CBD products multiply, understanding how different delivery methods affect blood levels is essential for dosing consistency. This small Phase I trial provides pharmacokinetic groundwork for a newer formulation type.

Questions still open

How does wafer performance differ in patients vs. healthy volunteers? Would higher doses maintain the bioequivalence? How does food intake affect wafer absorption?

Common questions

How long does it take for CBD to reach peak levels?

In this study, peak CBD concentrations occurred about 4 hours after taking either the sublingual wafer or oil solution, with an elimination half-life of approximately 6 hours.

Were there any side effects?

Side effects were mild and included drowsiness, sedation, and altered mood. Both the wafer and oil formulations were generally well tolerated.

Read the original research

A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.

British journal of clinical pharmacology, 87(4), 2070-2077

View on PubMed ↗Publisher’s paper ↗

Citation

Hosseini, Adele; McLachlan, Andrew J; Lickliter, Jason D. (2021). A phase I trial of the safety, tolerability and pharmacokinetics of cannabidiol administered as single-dose oil solution and single and multiple doses of a sublingual wafer in healthy volunteers.. British journal of clinical pharmacology, 87(4), 2070-2077. https://doi.org/10.1111/bcp.14617