Abstract
Background
The cannabis plant presents a complex biochemical unit of over 500 constituents of which 70 or more molecules have been classified as cannabinoids binding to cannabinoid receptors. The study aimed to investigate the safety, tolerability, and preliminary pharmacokinetics of a nanoparticle CBD formulation.
Methods
The cannabis-based medicine was elaborated with a micellular technology, to produce a water-soluble nanoparticle CBD-dominant anti-inflammatory cannabis medicine (MDCNB-02). On day one, 12 participants administered 2 sprays and on day 2 administered 6 sprays to alternating right and left cheeks [18 mg of CBD and 0.72 mg of THC]. Four other participants administered 2 and 6 sprays on days 1 and 2, respectively of a nanoparticle placebo.
Results
The study met the primary outcomes of safety, tolerability, and preliminary pharmacokinetics of a standardized CBD-dominant anti-inflammatory extract for oro-buccal administration. Bioavailability of a 6 mg and 18 mg dose of CBD (median IQR) was 0.87 and 8.9 ng h mL−1, respectively. The maximum concentration of CBD for the low and high doses administered once per day occurred at 60 min for both concentrations. The median half-life of the 6 mg and 18 mg CBD dose was 1.23 and 5.45 h, respectively. The apparent clearance of CBD was 115 and 34 L min−1 for a 6 mg and 18 mg dose, respectively.
Conclusion
The oro-buccal nanoparticle formulation achieved plasma concentrations that were largely comparable to other commercial and investigated formulations relative to the concentrations administered. Moreover, there were no reports of adverse effects associated with unfavorable inflammatory sequalae.
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Acknowledgements
We acknowledge the assistance of Serena Dal Forno RN. The authors thank the volunteers that participated in the study and the Scientia Clinical Research facility for managing the study.
Funding
This research was funded by Medlab Clinical Ltd. Australia.
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Conceptualisation, LV, JH, SH; methodology, BB, LV SH; formal analysis, BB, LV; investigation, Scientia Clinical Research facility (see Methods section); resources, Scientia Clinical Research facility (see Methods section); data curation, BB; writing—original draft preparation, LV, JDH, SH BB; writing—review and editing, LV, BB JDH, DR, SH.; project administration, LV, SH; funding acquisition, SH. All authors have read and agreed to the published version of the manuscript.
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BB is an independent statistician who was funded by Medlab Clinical Ltd Australia to conduct the statistical analysis. JDH DR SH and LV are employed by Medlab Clinical Ltd Australia and participate in its cannabis-based medicines research program and the pilot exploratory PK clinical trial administered formulations MDCNB-02 (NanaBidial™) and MDCNB-01 (NanaBis™).
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Vitetta, L., Butcher, B., Henson, J.D. et al. 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. Inflammopharmacol 29, 1361–1370 (2021). https://doi.org/10.1007/s10787-021-00859-y
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DOI: https://doi.org/10.1007/s10787-021-00859-y