Study: Comparison of the pharmacokinetics of a CBD soft gel formulation to 25mg of CBD delivered via CURE’s oral thin film

Share This Post

Share on facebook
Share on linkedin
Share on twitter
Share on email

These results are supplied for informational purposes only

Study title:
Comparison of the pharmacokinetics of a commercially available soft gel formulation of 25mg CBD to 25mg of CBD delivered via CUREfilm®, an oral thin film dose form.

Introduction:
Cannabidiol (CBD), a phytocannabinoid compound, has limited oral bioavailability due to the fat-soluble characteristics of the molecule, challenging absorption in the aqueous environment of the body. Additionally, CBD experiences extensive degradation due to the effects of first pass metabolism.

Study objective:
To compare the pharmacokinetics of a commercially available soft gel formulation (liquid encapsulated within a shell) of 25mg CBD to 25mg of CBD delivered via CUREfilm®, CURE’s oral thin film (OTF) dose form.

Methodology:
Open-label, randomized, single-dose, crossover study.

Study participants:
14 healthy adults with equal representation of gender (8 males, 6 females).

Study treatment:
Investigational product: CUREfilm®, an oral thin film dose form
Formulation: 25 mg cannabidiol in an oral thin film dose form
Route of administration: Oral administration, under fasting conditions
Dose regimen: 25mg

Reference product: Commercially available CBD soft gel
Formulation: 25 mg cannabidiol
Route of administration: Oral administration, under fasting conditions
Dose regimen: 25mg

Results:

Note: 0.5, 1 and 2 hours are statistically significant with PV < 0.05

CUREfilm® resulted in a significantly higher maximum serum concentration (~3x increase in Cmax) and a faster onset/absorption (~3x decrease in Tmax), compared to the soft gel.

No safety concerns were reported. In both arms of the study, the product was administered orally (PO) and ingested by the study participants.

As part of the study, a subjective survey comprising eight questions was conducted, to aid in the understanding of oral thin film as an acceptable dosage form. The survey results indicated that none of the participants felt discomfort, pain, numbness or irritation during administration.

80% indicated “great” palatability, with 90% rating CUREfilm® OTF experience as very pleasant or neutral.

Conclusion
CURE’s delivery platform improved cannabinoid bioavailability, suggesting that CURE’s technology, which entails solubilization and encapsulation of the CBD molecule, could deliver better results than solubilization alone and may play a synergistic or additive role in the bioavailability of actives.

CURE’s encapsulation technology improves bioavailability of CBD as well as other cannabinoid molecules that are given together and where lack of absorption or in high dosage amounts could have unfavorable side effects.

More To Explore