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Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents

The conundrum of Cannabis sativa’s applications for therapeutical purposes is set apart by the hundreds of known and commercially available strains, the social, cultural and historical context, and the legalization of its use for medical purposes in various jurisdictions around the globe. In an era...

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Autores principales: Filipiuc, Leontina-Elena, Ştefănescu, Raluca, Solcan, Carmen, Ciorpac, Mitică, Szilagyi, Andrei, Cojocaru, Dana, Stanciu, Gabriela Dumitrita, Creangă, Ioana, Caratașu, Cătălin-Cezar, Ababei, Daniela-Carmen, Gavrila, Roxana-Elena, Timofte, Andrei-Daniel, Filipiuc, Silviu-Iulian, Bild, Veronica
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10223347/
https://www.ncbi.nlm.nih.gov/pubmed/37242477
http://dx.doi.org/10.3390/ph16050694
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author Filipiuc, Leontina-Elena
Ştefănescu, Raluca
Solcan, Carmen
Ciorpac, Mitică
Szilagyi, Andrei
Cojocaru, Dana
Stanciu, Gabriela Dumitrita
Creangă, Ioana
Caratașu, Cătălin-Cezar
Ababei, Daniela-Carmen
Gavrila, Roxana-Elena
Timofte, Andrei-Daniel
Filipiuc, Silviu-Iulian
Bild, Veronica
author_facet Filipiuc, Leontina-Elena
Ştefănescu, Raluca
Solcan, Carmen
Ciorpac, Mitică
Szilagyi, Andrei
Cojocaru, Dana
Stanciu, Gabriela Dumitrita
Creangă, Ioana
Caratașu, Cătălin-Cezar
Ababei, Daniela-Carmen
Gavrila, Roxana-Elena
Timofte, Andrei-Daniel
Filipiuc, Silviu-Iulian
Bild, Veronica
author_sort Filipiuc, Leontina-Elena
collection PubMed
description The conundrum of Cannabis sativa’s applications for therapeutical purposes is set apart by the hundreds of known and commercially available strains, the social, cultural and historical context, and the legalization of its use for medical purposes in various jurisdictions around the globe. In an era where targeted therapies are continuously being developed and have become the norm, it is imperative to conduct standardized, controlled studies on strains currently cultivated under Good Manufacturing Practices (GMP) certification, a standard that guarantees the quality requirements for modern medical and therapeutic use. Thus, the aim of our study is to evaluate the acute toxicity of a 15.6% THC: <1% CBD, EU-GMP certified, Cannabis sativa L. in rodents, following the OECD acute oral toxicity guidelines, and to provide an overview of its pharmacokinetic profile. Groups of healthy female Sprague-Dawley rats were treated orally with a stepwise incremental dose, each step using three animals. The absence or presence of plant-induced mortality in rats dosed at one step determined the next step. For the EU GMP-certified Cannabis sativa L. investigated, we determined an oral LD50 value of over 5000 mg/kg in rats and a human equivalent oral dose of ≈806.45 mg/kg. Additionally, no significant clinical signs of toxicity or gross pathological findings were observed. According to our data, the toxicology, safety and pharmacokinetic profile of the tested EU-GMP-certified Cannabis sativa L. support further investigations through efficacy and chronic toxicity studies in preparation for potential future clinical applications and especially for the treatment of chronic pain.
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spelling pubmed-102233472023-05-28 Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents Filipiuc, Leontina-Elena Ştefănescu, Raluca Solcan, Carmen Ciorpac, Mitică Szilagyi, Andrei Cojocaru, Dana Stanciu, Gabriela Dumitrita Creangă, Ioana Caratașu, Cătălin-Cezar Ababei, Daniela-Carmen Gavrila, Roxana-Elena Timofte, Andrei-Daniel Filipiuc, Silviu-Iulian Bild, Veronica Pharmaceuticals (Basel) Article The conundrum of Cannabis sativa’s applications for therapeutical purposes is set apart by the hundreds of known and commercially available strains, the social, cultural and historical context, and the legalization of its use for medical purposes in various jurisdictions around the globe. In an era where targeted therapies are continuously being developed and have become the norm, it is imperative to conduct standardized, controlled studies on strains currently cultivated under Good Manufacturing Practices (GMP) certification, a standard that guarantees the quality requirements for modern medical and therapeutic use. Thus, the aim of our study is to evaluate the acute toxicity of a 15.6% THC: <1% CBD, EU-GMP certified, Cannabis sativa L. in rodents, following the OECD acute oral toxicity guidelines, and to provide an overview of its pharmacokinetic profile. Groups of healthy female Sprague-Dawley rats were treated orally with a stepwise incremental dose, each step using three animals. The absence or presence of plant-induced mortality in rats dosed at one step determined the next step. For the EU GMP-certified Cannabis sativa L. investigated, we determined an oral LD50 value of over 5000 mg/kg in rats and a human equivalent oral dose of ≈806.45 mg/kg. Additionally, no significant clinical signs of toxicity or gross pathological findings were observed. According to our data, the toxicology, safety and pharmacokinetic profile of the tested EU-GMP-certified Cannabis sativa L. support further investigations through efficacy and chronic toxicity studies in preparation for potential future clinical applications and especially for the treatment of chronic pain. MDPI 2023-05-03 /pmc/articles/PMC10223347/ /pubmed/37242477 http://dx.doi.org/10.3390/ph16050694 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Filipiuc, Leontina-Elena
Ştefănescu, Raluca
Solcan, Carmen
Ciorpac, Mitică
Szilagyi, Andrei
Cojocaru, Dana
Stanciu, Gabriela Dumitrita
Creangă, Ioana
Caratașu, Cătălin-Cezar
Ababei, Daniela-Carmen
Gavrila, Roxana-Elena
Timofte, Andrei-Daniel
Filipiuc, Silviu-Iulian
Bild, Veronica
Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title_full Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title_fullStr Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title_full_unstemmed Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title_short Acute Toxicity and Pharmacokinetic Profile of an EU-GMP-Certified Cannabis sativa L. in Rodents
title_sort acute toxicity and pharmacokinetic profile of an eu-gmp-certified cannabis sativa l. in rodents
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10223347/
https://www.ncbi.nlm.nih.gov/pubmed/37242477
http://dx.doi.org/10.3390/ph16050694
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