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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22330%2F21%3A43922073" target="_blank" >RIV/60461373:22330/21:43922073 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/60461373:22340/21:43922073 RIV/60461373:22810/21:43922073 RIV/67985858:_____/21:00559341

Výsledek na webu

<a href="https://www.mdpi.com/1999-4923/13/3/412/htm" target="_blank" >https://www.mdpi.com/1999-4923/13/3/412/htm</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/pharmaceutics13030412" target="_blank" >10.3390/pharmaceutics13030412</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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 degrees C +/- 2 degrees C/60% RH +/- 5% and 40 degrees C +/- 2 degrees 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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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 degrees C +/- 2 degrees C/60% RH +/- 5% and 40 degrees C +/- 2 degrees 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

10406 - Analytical chemistry

Projekt

<a href="/cs/project/VI20172020056" target="_blank" >VI20172020056: Nové syntetické drogy - komplexní mezioborové výzkumné centrum</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

PHARMACEUTICS

ISSN

1999-4923

e-ISSN

—

Svazek periodika

13

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

10

Strana od-do

412

Kód UT WoS článku

000634052400001

EID výsledku v databázi Scopus

2-s2.0-85103095414