Cannabinoids concentration variability in cannabis olive oil galenic preparations

Carcieri, Chiara; Tomasello, Cristina; Simiele, Marco; Nicolò, Amedeo De; Avataneo, Valeria; Canzoneri, Luca; Cusato, Jessica; Perri, Giovanni Di; D’Avolio, Antonio

doi:10.1111/jphp.12845

Cited by 55 publications

(73 citation statements)

References 27 publications

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“…Reports of inaccurate labelling and batch-to-batch variation of active ingredients within magistral CME preparations confirm fears that these products lack standardisation [29, 91, 92]. Being able to characterise accurately the complexity of botanical drug forms and to discriminate the efficacy of their constituents both singularly and in combination remains challenging [93].…”

Section: Resultsmentioning

confidence: 99%

“…The legitimacy of cannabinoid determinations among laboratories is a contentious subject and one which is becoming increasingly acknowledged within the literature [29, 52, 79]. The evaluation of reproducibility involves an inter-laboratory collaborative trial.…”

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

“…[79]. Analysis of ∼200 oil-based CME of Cannabis varieties Bedrocan®, Bedrobinol® and Bediol® prepared at ten pharmacies in Italy showed RSD > 50% among the cannabinoids tested [29], although variation from the inter-pharmacy extraction procedures could not be disentangled from batch-to-batch variation within these registered clonally-propagated plant strains.…”

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

“…Whilst a large number of analytical techniques have been employed for the quantification of Cannabis botanical raw material [28], including the monograph Cannabis Flos from the Dutch Office of Medicinal Cannabis, limited attention has been given to the quantification of cannabinoids within Cannabis botanical drug substances or CME [27-29, 52]. This is of significant concern given the effects different extraction protocols could have on sample matrices, the chemical composition of active ingredients [27], storage requirements [45, 53] and subsequent quantitative assessment of cannabinoids.…”

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

“…Despite the promising global outlook for Cannabis -based drug development, a critical step forward for this emerging industry is the establishment of robust standardised methods for the quantification of cannabinoids within a wide and growing range of Cannabis -based drug forms [26-29]. Refinement of these methodologies and standardisation of approach will be necessary to establish a foundation for future drug development, application and manufacture and will be required to ensure the identity, efficacy, purity, quality and potency of impending pharmaceutical-grade drugs derived from Cannabis .…”

Section: Introductionmentioning

confidence: 99%

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Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Welling¹,

Liu²,

Hazekamp³

et al. 2019

Med Cannabis Cannabinoids

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The plant genus Cannabis is a prolific producer of unique pharmaceutically relevant metabolites, commonly referred to as cannabinoids. Robust and standardised methods for the quantification of cannabinoids within botanical and drug forms is a critical step forward for an emerging Cannabis-based pharmaceutical industry, which is poised for rapid expansion. Despite a growing body of analytical methods for the quantification of cannabinoids, few have been validated using internationally accredited guidelines. Moreover, standardised methods have yet to be developed for application at various stages of manufacture as well as for different levels of processing and refinement. Validation parameters for establishing robust standardised methods for cannabinoid quantification within Cannabis-based drug forms are critically discussed. Determining an appropriate level of specificity (discrimination) among heterogeneous botanical matrices as well as evaluating accuracy (recovery) and inter-laboratory precision (reproducibility) within strict and volatile regulatory environments are potential obstacles to the establishment of robust analytical procedures. We argue that while some of these challenges remain unique to Cannabis, others are common to botanical-based drug development and manufacture. In order to address potential barriers to analytical method standardisation, a collaborative research initiative inclusive of academic and commercial stakeholders is proposed.

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Section: Resultsmentioning

confidence: 99%

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Welling¹,

Liu²,

Hazekamp³

et al. 2019

Med Cannabis Cannabinoids

View full text Add to dashboard Cite

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Risk of unintentional antidoping rule violations by consumption of hemp products

Mareck

Fußhöller

Schertel

et al. 2022

Drug Testing and Analysis

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Consumption of hemp products is continuously growing, with an expanding scope of applications. Suppliers operate through different distribution channels, but the Internet is a major retail platform. Hemp products are prepared from cannabis plants and, therefore, might contain a variety of different natural cannabinoids. According to the regulations of the World Anti‐Doping Agency, all natural and synthetic cannabinoids are prohibited in‐competition, with the explicit exemption of cannabidiol. Therefore, an investigation of 23 hemp products for the presence of cannabinoids was performed to determine the likelihood of unintentional violations of anti‐doping regulations. An assay for the detection of 16 cannabinoids in nutritional supplements was developed and validated. The sample preparation consisted of QuEChERS extraction, trimethylsilylation, and analysis by gas chromatography/tandem mass spectrometry. All 23 commercially available hemp products were analyzed, and assay characteristics such as selectivity, limit of detection, limit of identification, limit of quantification, linearity, imprecision, recovery, and accuracy were determined. Twenty of 23 hemp products included a variety of cannabinoids at, occasionally, substantial concentrations, with four products covering the entire spectrum of tested cannabinoids. An ethics committee‐approved single‐dose administration study was conducted with the commercially available hemp products, investigating the presence of 16 cannabinoids in urine collected pre‐ and post‐consumption. Variable patterns of cannabinoids or their metabolites in urine were observed. In 30% of the urine samples collected 8 h after ingestion, the presence of a prohibited cannabinoid would have resulted in an unintentional violation of anti‐doping regulations.

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Characterization of CBD oils, seized on the Belgian market, using infrared spectroscopy: Matrix identification and CBD determination, a proof of concept

Duchateau,

Stévigny,

De Braekeleer

et al. 2023

Drug Testing and Analysis

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The availability of cannabidiol (CBD) oil products has increased in recent years. No analytical controls are mandatory for these products leading to uncertainties about composition and quality. In this paper, a methodology was developed to identify the oil matrix and to estimate the CBD content in such samples, using mid‐infrared and near‐infrared spectroscopy. Different oils were selected based on the information labeled on products and were bought in food stores in order to create a sample set with a variety of matrices. These oils were spiked with CBD to obtain samples with CBD levels from 0% to 20%. The first part of the study was focused on the qualitative analysis of the oil matrix. A classification model, based on Soft Independent Modeling of Class Analogy, was build using the spiked oils to distinguish between the different oil matrices. For both spectroscopic techniques, the sensitivity, the specificity, the accuracy and the precision were equal to 100%. These models were applied to determine the oil matrix of seized samples. The second part of the study was focused on the quantitative estimation of CBD. After determination of CBD in seized samples using gas chromatography‐tandem mass spectrometry, partial least square regression (PLS‐R) models were built, one for each matrix in the sample set. Both techniques were able to classify unknown oily samples according to their matrix, and although only few samples were available to evaluate the PLS‐R models, the approach clearly showed promising results for the estimation of the CBD content in oil samples.

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Cannabinoids concentration variability in cannabis olive oil galenic preparations

Cited by 55 publications

References 27 publications

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Developing Robust Standardised Analytical Procedures for Cannabinoid Quantification: Laying the Foundations for an Emerging Cannabis-Based Pharmaceutical Industry

Risk of unintentional antidoping rule violations by consumption of hemp products

Characterization of CBD oils, seized on the Belgian market, using infrared spectroscopy: Matrix identification and CBD determination, a proof of concept

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