Inorganic element profile of medicinal <i>Cannabis</i> extracts consumed by pediatric patients

Santos, Lisia Maria Gobbo dos; Vicentini Neto, Santos Alves; Barata-Silva, Cristiane; Fonseca, Mayssa de Andrade; Magalhães, Carolina Duque; Carvalho, Virgínia Martins; Rocha, Ernesto Díaz; Jacob, Silvana do Couto

doi:10.1590/s2175-97902022e20176

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Brazilian Journal of Pharmaceutical Sciences

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Article • Braz. J. Pharm. Sci. 58 • 2022 • https://doi.org/10.1590/s2175-97902022e20176 copy

Inorganic element profile of medicinal Cannabis extracts consumed by pediatric patients

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

The increasing number of reports of web-based experiences on the success of Cannabis-based therapies in controlling seizures in children suffering from refractory epilepsy have led to efforts by governments and associations to a recent change in legislation. The Brazilian Health Regulatory Agency (ANVISA) allowed the import of Cannabis extracts in 2015 and the registration of the first industrialized drug in 2017. In 2019, ANVISA approved procedures for the granting of a Sanitary Authorization for manufacturing and imports, establishing marketing requirements, prescribing, dispensing, monitoring and surveillance of cannabis products for medicinal purposes. Similar to other consumer products of health concern, is necessary to ensure the quality and health safety of these products worldwide. The aim of the present study to evaluate the presence of As, Cd, Pb, Ni, Cu, Co, Cr and Mn present in Cannabis extracts and resins used in the treatment of pediatric patients with neurological diseases. Samples (48 national and 24 imported) were analyzed by Inductively Coupled Plasma Mass Spectrometry - ICP-MS. The imported extracts presented more homogeneous inorganic element values, while national extracts showed varied levels, thus indicating the highest health risk.

Keywords:
Elements; Mass spectrometry; Cannabis; Public Health

Element	Isotope mass	LD	LD*	Recovery	%CV	Working range
Element	(AMU)	(µg L^-1)	(mg kg ^-1)	(%)	(n=5)	(μg L^-1)
As	75	0.005	0.0008	104	14	0.1-10
Cd	111	0.005	0.0008	109	11	0.1-10
Pb	208	0.043	0.0065	114	14	0.1-10
Ni	60	0.023	0.0035	81	13	0.1-10
Cu	63	0.005	0.0007	110	14	0.1-10
Co	59	0.014	0.0021	105	16	0.1-10
Cr	52	0.022	0.0033	88	16	0.1-10
Mn	55	0.025	0.0038	120	14	0.1-20

			As	Cd	Pb	Cr	Cu	Ni	Co	Mn	CBDt*	THCt*
			mg kg^-1								mg mL^-1
Imported (Commercial products)	USA (n=18)	Means	0.05	0.02	0.3	6.2	2.0	2.4	0.05	1.1	82.0	1.6
		Median	0.03	0.01	0.24	5.3	0.7	0.6	0.02	0.9	52.4	1.4
		Range	0.01 - 0.13	0.004 - 0.05	0.03-0.7	0.3-29.0	0.2- 16.7	0.1-17.6	0.004-0.31	0.1-4.0	13.- 284	0 - 4.3
	Canada (n=1)	Means	0.008	0.02	0.15	0.6	0.2	0.08	0.006	0.04	22.2	2.9
	Germany (n=1)	Means	0.2	0.004	0.2	5.8	26.9	1.2	0.004	7.6	146.4	9.5
National (Artisanal extracts)	Rio de Janeiro (n=21)	Means	0.08	0.03	0.3	5.3	1.2	0.7	0.5	10.7	4.1	3.1
		Median	0.16	0.01	0.1	2.1	0.3	0.2	0.02	1.1	3.1	2.1
		Range	0.01-0.4	0.- 0.2	0.03-4.0	0.50-30.7	0.07-14.9	0.02-5.3.2	<0.002-7.6	0.4-49.5.1	0-21.1	0-13.7
	Santa Catarina (n=7)	Means	0.06	0.02	0.1	4.7	1.1	1.7	0.08	2.3	2.0	26.8
		Median	0.06	0.02	0.07	0.8	0.2	4.2	0.002	0.4	1.8	30.1
		Range	0.007-0.1	0.008-0.02	0.02-0.3	0.6-24.2	0.02-4.4	0.02-10.1	<0.002-0.3	0.16-12.4	0.69-4.7	9.82-43.6
	Minas Gerais (n=3)	Means	0.04	0.02	0.6	2.8	2.2	2.6	0.06	1.9	0.06	0
		Median	0.03	0.01	0.2	1.8	0.7	0.7	0.04	1.2	0.01	0
		Range	0.03-0.07	0.008-0.05	0.02-1.2	1.7-5.7	0.6-4.4	0.4-7.9	0.03-0.10	0.8-4.6	0-0.18	0
	Paraiba (n=9)	Means	0.02	0.03	0.10	1.7	0.7	0.3	0.007	0.4	0.1	0.2
		Median	0.01	0.01	0.11	0.24	0.3	0.1	0.007	0.4	0.1	0.2
		Range	0.006-0.06	0.01-0.02	0.05-0.13	0.2-4.0	0.1-4.5	0.08-1.3	0.005-0.01	0.2-0.8	0-0.35	0-1.5
	Piaui (n=3)	Means	0.10	0.02	0.04	0.5	0.1	0.07	< 0.002	0.3	1.2	0.2
		Median	0.12	0.02	0.03	0.5	0.1	0.07	< 0.002	0.2	1.2	0.2
		Range	0.04-0.1	0.15-0.16	0.03-0.05	0.30-0.6	0.06-0.2	0.05-0.7	-----------	0.2-0.5	0-2.3	0-0.6

		As	Cd	Pb	Cr	Cu	Ni	Co	Mn	CBDt*	THCt*
		mg kg ^-1								mg mL ^-1
Imported
Oil	Means±SD	0.04±0.08	0.02±0.01	0.2±0.2	6.1±7.3	1.37±2.0	2.10±4.7	0.04±0.07	1.1±0.9	78.8±66.0	1.68±1.4
Oil	Range	0.1-0.1	0.01-0.05	0.03-0.6	0.2-29.0	0.1-8.3	0.05-17.6	0-0.3	0.4-4.0	41-210	0-4.2
Resin	Means	0.08±0.06	0.01±0.004	0.3±0.2	5.4±1.2	9.3±12.0	2.9±4.5	0.07±0.02	2.2±2.7	152±30	4.9±3
Resin	Range	0.04-0.2	0.01-040	0.1-0.8	3.7-6.1	0.5-27	1.1-11.0	0.04-0.09	0.9-7.0	104-189.4	2.6-9.5
National
Oil	Means	0.06±0.08	0.02±0.03	0.2±0.6	3.9±6.7	0.9±2.3	0.9±7.4	0.1±1.3	3.1±16.1	2.0±4.1	5.8±11.0
Oil	Range	0.01-0.4	<0.002-0.2	0.3-4.1	0.3-24.2	0.1-4.5	0.02-10.1	<0.002-7.6	0.05-79.3	0-12.14	0-43.6
Resin	Means	0.1±0.05	0.01±0.02	1.2±1.3	8.5±4.2	3.7±1.1	3.8±2.9	0.1±0.1	17.4±21.7	12 ±8	250±143
Resin	Range	0.05-0.2	0.01-0.02	0.3-3.1	5.6-14.5	2.7-4.9	1.2-7.9	0.05-0.3	5.6-49.5	0.3-16.8	37-349

Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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[1] *Correspondence: L. M. G. dos Santos. Setor de Elementos Inorgânicos. Departamento de Química, INCQS/Fiocruz. Av Brasil, 4365. CEP: 21040-900, Rio de Janeiro, RJ, Brasil. Phone: (0xx21) 38655258. E-mail: lisia.gobbo@ incqs.fiocruz.br.

Radio frequency power	1400 W
Cone/Skimmer/hyper-skimmer	Platinum
Mediated signal	Peak Hopping
Scan per reading	50
Dwell time	15 ms
Replicate reading	1
Replicates	3
Nebulizer gas flow	1 L min^-1
Internal Standard	10 µg L^-1 Rh