A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery.
Cannabinoids
Nanoparticles
Oromucosal spray
Pharmacokinetics
Safety
Journal
Medical cannabis and cannabinoids
ISSN: 2504-3889
Titre abrégé: Med Cannabis Cannabinoids
Pays: Switzerland
ID NLM: 101765665
Informations de publication
Date de publication:
2022
2022
Historique:
received:
14
07
2021
accepted:
24
11
2021
entrez:
28
2
2022
pubmed:
1
3
2022
medline:
1
3
2022
Statut:
epublish
Résumé
A phase I, open-label clinical trial in healthy male subjects was conducted to assess the pharmacokinetic and safety profile of an oromucosal cannabinoid spray (AP701) containing a lipid-based nanoparticular drug formulation standardized to ∆-9-tetrahydrocannabinol (THC). Twelve healthy male subjects received a single dose of AP701 (12 sprays) containing 3.96 mg THC. Plasma samples were drawn 10 min-30 h post dose for analysis of THC and the active metabolite 11-hydroxy-∆-9-THC (11-OH-THC). The single dose of the applied oromucosal cannabinoid spray AP701 (12 sprays, 3.96 mg THC) resulted in a mean maximum plasma concentration ( Compared to currently available drugs on the market, higher AUC values could be detected for the oromucosal cannabinoid spray AP701 despite administration of a lower dose. These comparatively higher blood levels caused only minor psychotropic adverse effects. The oromucosal cannabinoid spray AP701 was well tolerated at a single dose of 3.96 mg THC. The oromucosal administration may provide an easily applicable and titratable drug formulation with a high safety and tolerability profile.
Identifiants
pubmed: 35224436
doi: 10.1159/000521352
pii: mca-0005-0009
pmc: PMC8832248
doi:
Types de publication
Journal Article
Langues
eng
Pagination
9-19Informations de copyright
Copyright © 2022 by S. Karger AG, Basel.
Déclaration de conflit d'intérêts
AP701 is manufactured by Apurano Pharmaceuticals GmbH, clinically developed as drug product, and marketed by CannaXan GmbH. S. Lorenzl, R. Grötsch, G. Haber, C. Bremm, and C. Weck were contracted to perform the clinical trial. A. Nistler and L. Brehm are employees of Apurano Pharmaceuticals GmbH, F. Gottwald, and C. Trummer are employees of CannaXan GmbH. W. Brand is Managing Director of both companies.
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