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Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution

Stability studies represent an essential component of pharmaceutical development, enabling critical evaluation of the therapeutic potential of an active pharmaceutical ingredient (API) or a final pharmaceutical product under the influence of various environmental factors. The aim of the present stud...

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Detalles Bibliográficos
Autores principales: Kosović, Ema, Sýkora, David, Kuchař, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003596/
https://www.ncbi.nlm.nih.gov/pubmed/33808893
http://dx.doi.org/10.3390/pharmaceutics13030412
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author Kosović, Ema
Sýkora, David
Kuchař, Martin
author_facet Kosović, Ema
Sýkora, David
Kuchař, Martin
author_sort Kosović, Ema
collection PubMed
description Stability studies represent an essential component of pharmaceutical development, enabling critical evaluation of the therapeutic potential of an active pharmaceutical ingredient (API) or a final pharmaceutical product under the influence of various environmental factors. The aim of the present study was to investigate the chemical stability of cannabidiol (CBD) in the form of a solid powder (hereinafter referred to as CBD powder) and also dissolved in sunflower oil. We performed stress studies in accordance with the International Conference on Harmonization (ICH) guidelines, where 5 mg of marketed CBD in the form of a solid powder and in form of oil solution were exposed for 7 and 14, 30, 60, 90, 180, 270, and 365 days to precisely defined temperature and humidity conditions, 25 °C ± 2 °C/60% RH ± 5% and 40 °C ± 2 °C/75% RH ± 5% in both open and closed vials in the dark. CBD powder was significantly more stable than CBD in oil solution. Such finding is important because CBD is often administered dissolved in oil matrix in practice due to very good bioavailability. Thus, the knowledge on admissible shelf time is of paramount importance.
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spelling pubmed-80035962021-03-28 Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution Kosović, Ema Sýkora, David Kuchař, Martin Pharmaceutics Article Stability studies represent an essential component of pharmaceutical development, enabling critical evaluation of the therapeutic potential of an active pharmaceutical ingredient (API) or a final pharmaceutical product under the influence of various environmental factors. The aim of the present study was to investigate the chemical stability of cannabidiol (CBD) in the form of a solid powder (hereinafter referred to as CBD powder) and also dissolved in sunflower oil. We performed stress studies in accordance with the International Conference on Harmonization (ICH) guidelines, where 5 mg of marketed CBD in the form of a solid powder and in form of oil solution were exposed for 7 and 14, 30, 60, 90, 180, 270, and 365 days to precisely defined temperature and humidity conditions, 25 °C ± 2 °C/60% RH ± 5% and 40 °C ± 2 °C/75% RH ± 5% in both open and closed vials in the dark. CBD powder was significantly more stable than CBD in oil solution. Such finding is important because CBD is often administered dissolved in oil matrix in practice due to very good bioavailability. Thus, the knowledge on admissible shelf time is of paramount importance. MDPI 2021-03-19 /pmc/articles/PMC8003596/ /pubmed/33808893 http://dx.doi.org/10.3390/pharmaceutics13030412 Text en © 2021 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 (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ).
spellingShingle Article
Kosović, Ema
Sýkora, David
Kuchař, Martin
Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title_full Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title_fullStr Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title_full_unstemmed Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title_short Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution
title_sort stability study of cannabidiol in the form of solid powder and sunflower oil solution
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8003596/
https://www.ncbi.nlm.nih.gov/pubmed/33808893
http://dx.doi.org/10.3390/pharmaceutics13030412
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