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Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications.
Front Pharmacol. 2018; 9:1543.FP

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 <LOQ in all Bedrocan samples, and CBN and THCA were <LOQ in all Bedrolite samples. As for FM-2, a significant inter-laboratories variability was found for CBD concentrations.

Conclusion:

Quantitative variability of cannabinoids in magistral preparations might impact on the efficacy and safety of therapeutic cannabis. A standardized protocol is needed to guarantee a homogeneous product and patients' therapeutic continuity.

Authors+Show Affiliations

Section of Pharmacology and Toxicology, Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy. Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.Section of Pharmacology and Toxicology, Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy. Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.Section of Pharmacology and Toxicology, Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy. Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. Center for Integrative Medicine, Careggi University Hospital, University of Florence, Florence, Italy.Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. Center for Integrative Medicine, Careggi University Hospital, University of Florence, Florence, Italy.Section of Pharmacology and Toxicology, Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy. Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.Center for Integrative Medicine, Careggi University Hospital, University of Florence, Florence, Italy.Clinical Toxicology Laboratory, Local Health Service, Florence, Italy.Section of Pharmacology and Toxicology, Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy. Tuscan Regional Centre of Pharmacovigilance and Phytovigilance, Florence, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30705629

Citation

Bettiol, Alessandra, et al. "Galenic Preparations of Therapeutic Cannabis Sativa Differ in Cannabinoids Concentration: a Quantitative Analysis of Variability and Possible Clinical Implications." Frontiers in Pharmacology, vol. 9, 2018, p. 1543.
Bettiol A, Lombardi N, Crescioli G, et al. Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications. Front Pharmacol. 2018;9:1543.
Bettiol, A., Lombardi, N., Crescioli, G., Maggini, V., Gallo, E., Mugelli, A., Firenzuoli, F., Baronti, R., & Vannacci, A. (2018). Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications. Frontiers in Pharmacology, 9, 1543. https://doi.org/10.3389/fphar.2018.01543
Bettiol A, et al. Galenic Preparations of Therapeutic Cannabis Sativa Differ in Cannabinoids Concentration: a Quantitative Analysis of Variability and Possible Clinical Implications. Front Pharmacol. 2018;9:1543. PubMed PMID: 30705629.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications. AU - Bettiol,Alessandra, AU - Lombardi,Niccolò, AU - Crescioli,Giada, AU - Maggini,Valentina, AU - Gallo,Eugenia, AU - Mugelli,Alessandro, AU - Firenzuoli,Fabio, AU - Baronti,Roberto, AU - Vannacci,Alfredo, Y1 - 2019/01/17/ PY - 2018/11/09/received PY - 2018/12/18/accepted PY - 2019/2/2/entrez PY - 2019/2/2/pubmed PY - 2019/2/2/medline KW - Bediol® KW - Bedrocan® KW - Bedrolite® KW - FM-2® KW - cannabis KW - concentrations variability KW - galenic preparations SP - 1543 EP - 1543 JF - Frontiers in pharmacology JO - Front Pharmacol VL - 9 N2 - 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 <LOQ in all Bedrocan samples, and CBN and THCA were <LOQ in all Bedrolite samples. As for FM-2, a significant inter-laboratories variability was found for CBD concentrations. Conclusion: Quantitative variability of cannabinoids in magistral preparations might impact on the efficacy and safety of therapeutic cannabis. A standardized protocol is needed to guarantee a homogeneous product and patients' therapeutic continuity. SN - 1663-9812 UR - https://www.unboundmedicine.com/medline/citation/30705629/Galenic_Preparations_of_Therapeutic_Cannabis_sativa_Differ_in_Cannabinoids_Concentration:_A_Quantitative_Analysis_of_Variability_and_Possible_Clinical_Implications_ L2 - https://doi.org/10.3389/fphar.2018.01543 DB - PRIME DP - Unbound Medicine ER -
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