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

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Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution pharmaceutics Article Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution Ema Kosovi´c 1,2 , David Sýkora 2 and Martin Kuchaˇr 3,* 1 Institute of Chemical Process Fundamentals of CAS v.v.i., Rozvojová 135, 16502 Prague, Czech Republic; [email protected] 2 Department of Analytical Chemistry, University of Chemistry and Technology Prague, Technická 5, 16628 Prague, Czech Republic; [email protected] 3 Forensic Laboratory of Biologically Active Substances, Department of Chemistry of Natural Compounds, University of Chemistry and Technology Prague, Technická 5, 16628 Prague, Czech Republic * Correspondence: [email protected] Abstract: Stability studies represent an essential component of pharmaceutical development, en- abling 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 Citation: Kosovi´c,E.; Sýkora, D.; very good bioavailability. Thus, the knowledge on admissible shelf time is of paramount importance. Kuchaˇr,M. Stability Study of Cannabidiol in the Form of Solid Keywords: cannabidiol; degradation; oil matrix; stability study; tetrahydrocannabinol; cannabinol Powder and Sunflower Oil Solution. Pharmaceutics 2021, 13, 412. https:// doi.org/10.3390/pharmaceutics 13030412 1. Introduction Academic Editor: Anne Marie Healy It has been known for thousands years that the cannabis plant interacts with the human body on many levels: to relieve neuropathic pain [1], to lower intraocular pres- Received: 2 February 2021 sure [2], to increase appetite [3], and to decrease nausea and vomiting [4]. The substances Accepted: 16 March 2021 responsible for these effects are collectively known as cannabinoids, among which the most Published: 19 March 2021 prominent are D9-tetrahydrocannabinol (THC), cannabidiol (CBD), and cannabinol (CBN) (Figure1). Due to the fact that a combination of psychoactive THC with non-psychoactive Publisher’s Note: MDPI stays neutral cannabinoids shows a higher activity than THC alone, a lot of effort and resources have with regard to jurisdictional claims in been invested in studying and isolating non-psychoactive alkaloids and their application published maps and institutional affil- in medicine [5]. iations. CBD is the second most prevalent active ingredient of cannabis, which does not possess any psychoactive effects. According to the report from World Health Organiza- tion, to-date, there is no evidence of public health related problems associated with the use of pure CBD [6]. Only a few publications can be found in the literature concerning Copyright: © 2021 by the authors. storage conditions and degradation of cannabinoids in general, where authors clearly Licensee MDPI, Basel, Switzerland. specify the storage conditions and individual forms of cannabis (oil, resin, etc.) [7,8]. The This article is an open access article mentioned papers emphasized a promising medical potential of CBD. Many clinical trials distributed under the terms and and government approvals have been completed or are currently underway. One of these conditions of the Creative Commons trials provided lung cancer treatment to patients with adenocarcinoma [9]. Earlier works Attribution (CC BY) license (https:// have shown that CBD has probably anti-neoplastic properties, but more recent data have creativecommons.org/licenses/by/ indicated that CBD may also provide a significant response in patients with this kind of 4.0/). Pharmaceutics 2021, 13, 412. https://doi.org/10.3390/pharmaceutics13030412 https://www.mdpi.com/journal/pharmaceutics Pharmaceutics 2021, 13, 412 2 of 10 shown that CBD has probably anti-neoplastic properties, but more recent data have indi- cated that CBD may also provide a significant response in patients with this kind of can- cer. However, on the other hand, there are some indications that CBD oil accelerates cer- Pharmaceuticstain2021 types, 13, 412 of cancers; therefore, cancer should be treated with great care and distinction2 of 10 as to what type of cancer is being treated [10]. Due to its promising results in early trials, there is an increasing interest in research of CBD as a dietary supplement with potential medicinal benefits. cancer. However, on the other hand, there are some indications that CBD oil accelerates To assure an adequatecertain types use of of cancers; CBD therefore, in medicine, cancer it should is necessary be treated to with know great careits physical, and distinction chemical, and biologicalas to what properties, type of cancer and is info beingrmation treated [ 10regarding]. Due to its stability promising and results shelf-life. in early trials, Lindholst [11] describedthere is cannabis an increasing resin interest and in ex researchtract as of CBDvery as susceptible a dietary supplement to degradation with potential medicinal benefits. caused by light, temperature,To assure and an adequateoxygen, use whil ofe CBD Carbone in medicine, et al. it [12] is necessary provided to know an almost its physical, complete review ofchemical, THC degradation and biological prod properties,ucts. and A informationsimilar degradation regarding stability mechanism and shelf-life. was Lind- proposed by Laytonholst et [al.11] [13], described who cannabis focused resin more and extracton the as identification very susceptible of to degradation caused products caused byby the light, above-mentioned temperature, and oxygen,factors, while but the Carbone results et al. are [12 ]not provided fully pharmaceu- an almost complete review of THC degradation products. A similar degradation mechanism was proposed by tically acceptable dueLayton to the et al. used [13], methanolic who focused morematrices on the and identification length of of the degradation study [14]. products caused The aim of ourby work the above-mentioned was to investigate factors, the but chemical the results stability are not fully of pharmaceuticallycommercially mar- acceptable keted formulations dueof CBD to the forms used methanolic under defin matricesed International and length of theConference study [14]. on Harmoniza- tion (ICH) guideline requirements.The aim of our The work stability was to investigate of CBD thewas chemical evaluated stability in ofthe commercially form of a mar- solid powder and anketed oil formulations solution for of CBDa one- formsyear under time defined period, International under ICH Conference stability on condi- Harmoniza- tion (ICH) guideline requirements. The stability of CBD was evaluated in the form of a tions. The study wassolid adapted powder andto the an oilclimate solution conditions for a one-year of time the period,country under where ICH stabilitythe experi- conditions. ment was conducted,The i.e., study the was Czech adapted Repub to thelic. climate High-performance conditions of the country liquidwhere chromatography the experiment was (HPLC) in combinationconducted, with i.e.,ultraviolet-visible the Czech Republic. (UV-Vis) High-performance spectroscopic liquid chromatographyand mass spectro- (HPLC) in metric (MS) detectioncombination was used with as ultraviolet-visible a suitable method (UV-Vis) for spectroscopicthe stability and measurements. mass spectrometric To (MS) detection was used as a suitable method for the stability measurements. To the best of our the best of our knowledge,knowledge, no no other other long-termlong-term stability stability study study of CBD of in CBD both thein both above-mentioned the above- forms mentioned forms hashas been been performed to-date. to-date. Figure 1. Chemical structures of active ingredient cannabidiol (CBD) and its possible degradation products (D9-tetrahydrocannabinol (D9-THC) and cannabinol (CBN)). Figure 1. Chemical structures of active ingredient cannabidiol (CBD) and its possible degradation products (Δ9-tetrahydrocannabinol2. Materials and (Δ Methods9-THC) and cannabinol (CBN)). 2.1. Chemicals and Reagents 2. Materials and MethodsCBD with a purity of 99.9% was purchased from Lipomed AG (Arlesheim, Switzer- land), CBN (>95%) from CBDepot s.r.o. (Teplice, Czech Republic), and D9-THC (>95%) 2.1. Chemicals and Reagentsfrom PharmaCan s.r.o. (Prague, Czech Republic). Methanol, acetonitrile, and formic acid CBD with a puritywere allof LC-MS99.9% gradewas andpurchased purchased from from Lipomed Merck (Prague, AG Czech(Arlesheim, Republic). Switzer- Flower Gold land), CBN (>95%) sunflowerfrom CBDepot oil, with s.r.o. saponification (Teplice, value Czech of 189–195 Republic), mg KOH/g and Δ and9-THC ratio (>95%) of 12:88 sat- urated:unsaturated fatty acids, was procured from Eseltix (Bratislava, Slovakia). Ultra- from PharmaCan s.r.o.pure (Prague, water used Czech for the Republic). LC-MS analyses Methanol, was obtained acetonitrile,
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