Introduction: Magistral preparations of therapeutic cannabis are extracted from standardized products imported from Holland or from the Florence Military Pharmaceutical Chemical Works, but extraction protocols differ among galenic laboratories. This study assessed the inter-laboratory variability in concentrations of cannabidiol (CBD), cannabinol (CBN), tetrahydrocannabinol (THC), and tetrahydrocannabinolic acid (THCA) among different magistral oil preparations. Methods: 219 samples of Bediol, Bedrobinol, Bedrolite or FM-2 70 or 100 mg/ml in oil were collected from 3 laboratories. Concentrations of CBD, CBN, THC, and THCA were quantified by high-pressure liquid chromatography; inter-laboratories variability was assessed using the Kruskal-Wallis test. Results: A significant variability in CBD and THC concentrations was found for Bediol 70 mg/ml samples from 2 laboratories [for CBD: median 5.4 (range 4.8-6.6) vs. 6.1 (4.9-7.2) mg/ml, p = 0.033; for THC: 3.6 (3.1-3.9) vs. 4.0 (2.6-5.1) mg/ml, p = 0.020]. As for Bediol 100 mg/ml, a significant variability emerged in THC concentrations among the three considered laboratories [5.7 (-) vs. 4.2 (1.5-4.8) vs. 5.2 (4.2-6.9), p = 0.030]. No significant inter-laboratory variability emerged for Bedrocan and Bedrolite. Concentrations of CBD, CBN, and THC were

Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications / Bettiol, Alessandra; Lombardi, Niccolò; Crescioli, Giada; Maggini, Valentina; Gallo, Eugenia; Mugelli, Alessandro; Firenzuoli, Fabio; Baronti, Roberto; Vannacci, Alfredo. - In: FRONTIERS IN PHARMACOLOGY. - ISSN 1663-9812. - ELETTRONICO. - 9:(2019), pp. 1543-1543. [10.3389/fphar.2018.01543]

Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications

Bettiol, Alessandra;Lombardi, Niccolò;Crescioli, Giada;Maggini, Valentina;Gallo, Eugenia;Mugelli, Alessandro;Firenzuoli, Fabio;Baronti, Roberto;Vannacci, Alfredo
2019

Abstract

Introduction: Magistral preparations of therapeutic cannabis are extracted from standardized products imported from Holland or from the Florence Military Pharmaceutical Chemical Works, but extraction protocols differ among galenic laboratories. This study assessed the inter-laboratory variability in concentrations of cannabidiol (CBD), cannabinol (CBN), tetrahydrocannabinol (THC), and tetrahydrocannabinolic acid (THCA) among different magistral oil preparations. Methods: 219 samples of Bediol, Bedrobinol, Bedrolite or FM-2 70 or 100 mg/ml in oil were collected from 3 laboratories. Concentrations of CBD, CBN, THC, and THCA were quantified by high-pressure liquid chromatography; inter-laboratories variability was assessed using the Kruskal-Wallis test. Results: A significant variability in CBD and THC concentrations was found for Bediol 70 mg/ml samples from 2 laboratories [for CBD: median 5.4 (range 4.8-6.6) vs. 6.1 (4.9-7.2) mg/ml, p = 0.033; for THC: 3.6 (3.1-3.9) vs. 4.0 (2.6-5.1) mg/ml, p = 0.020]. As for Bediol 100 mg/ml, a significant variability emerged in THC concentrations among the three considered laboratories [5.7 (-) vs. 4.2 (1.5-4.8) vs. 5.2 (4.2-6.9), p = 0.030]. No significant inter-laboratory variability emerged for Bedrocan and Bedrolite. Concentrations of CBD, CBN, and THC were
2019
9
1543
1543
Bettiol, Alessandra; Lombardi, Niccolò; Crescioli, Giada; Maggini, Valentina; Gallo, Eugenia; Mugelli, Alessandro; Firenzuoli, Fabio; Baronti, Roberto; Vannacci, Alfredo
File in questo prodotto:
File Dimensione Formato  
28 Bettiol A et al, 2018.pdf

accesso aperto

Tipologia: Versione finale referata (Postprint, Accepted manuscript)
Licenza: Open Access
Dimensione 207.46 kB
Formato Adobe PDF
207.46 kB Adobe PDF

I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1244215
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 19
  • ???jsp.display-item.citation.isi??? 19
social impact