Cargando…
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...
Autores principales: | , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1785049920038764544 |
---|---|
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. |
format | Online Article Text |
id | pubmed-10223347 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT filipiucleontinaelena acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT stefanescuraluca acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT solcancarmen acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT ciorpacmitica acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT szilagyiandrei acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT cojocarudana acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT stanciugabrieladumitrita acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT creangaioana acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT caratasucatalincezar acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT ababeidanielacarmen acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT gavrilaroxanaelena acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT timofteandreidaniel acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT filipiucsilviuiulian acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents AT bildveronica acutetoxicityandpharmacokineticprofileofaneugmpcertifiedcannabissativalinrodents |