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

0559341 - ÚCHP 2023 RIV CH eng J - Článek v odborném periodiku
Kosović, Ema - Sýkora, D. - Kuchař, M.
Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution.
Pharmaceutics. Roč. 13, č. 3 (2021), č. článku 412. E-ISSN 1999-4923
Institucionální podpora: RVO:67985858
Klíčová slova: cannabidiol * degradation * oil matrix
Obor OECD: Chemical engineering (plants, products)
Impakt faktor: 6.525, rok: 2021
Způsob publikování: Open access
https://www.mdpi.com/1999-4923/13/3/412

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.
Trvalý link: https://hdl.handle.net/11104/0332671