Evaluation of cannabinoids concentration and stability in standardized preparations of cannabis tea and cannabis oil by ultra-high performance liquid chromatography tandem mass spectrometry

Pacifici, Roberta; Marchei, Emilia; Salvatore, Francesco; Guandalini, Luca; Busardò, Francesco Paolo; Pichini, Simona

doi:10.1515/cclm-2016-1060

Cited by 109 publications

(103 citation statements)

References 21 publications

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“…Complicating matters are the allogamous (variable) and unstable nature of the Cannabis plant and the inherent inconsistencies in the chemical contents across plant batches and derived formulations, which are affected by genetic characteristics, but also environmental, cultivation, and storage conditions (Thomas and Pollard, 2016; Pacifici et al, 2017, 2018). These factors present challenges for both medical cannabis consumers and researchers as patients never have continuous access to cannabis products with precisely consistent chemotypes.…”

Section: Discussionmentioning

confidence: 99%

Patient-Reported Symptom Relief Following Medical Cannabis Consumption

Stith

Vigil

Brockelman³

et al. 2018

Front. Pharmacol.

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Background: The Releaf AppTM mobile software application (app) data was used to measure self-reported effectiveness and side effects of medical cannabis used under naturalistic conditions.Methods: Between 5/03/2016 and 12/16/2017, 2,830 Releaf AppTM users completed 13,638 individual sessions self-administering medical cannabis and indicated their primary health symptom severity rating on an 11-point (0–10) visual analog scale in real-time prior to and following cannabis consumption, along with experienced side effects.Results: Releaf AppTM responders used cannabis to treat myriad health symptoms, the most frequent relating to pain, anxiety, and depressive conditions. Significant symptom severity reductions were reported for all the symptom categories, with mean reductions between 2.8 and 4.6 points (ds ranged from 1.29–2.39, ps < 0.001). On average, higher pre-dosing symptom levels were associated with greater reported symptom relief, and users treating anxiety or depression-related symptoms reported significantly more relief (ps < 0.001) than users with pain symptoms. Of the 42 possible side effects, users were more likely to indicate and showed a stronger correlation between symptom relief and experiences of positive (94% of sessions) or a context-specific side effects (76%), whereas negative side effects (60%) were associated with lessened, yet still significant symptom relief and were more common among patients treating a depressive symptom relative to patients treating anxiety and pain-related conditions.Conclusion: Patient-managed cannabis use is associated with clinically significant improvements in self-reported symptom relief for treating a wide range of health conditions, along with frequent positive and negative side effects.

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Section: Discussionmentioning

confidence: 99%

Patient-Reported Symptom Relief Following Medical Cannabis Consumption

Stith

Vigil

Brockelman³

et al. 2018

Front. Pharmacol.

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“…Recent studies reported that cannabinoids concentrations in oil preparations vary according to temperature and time of extraction, other than highlighting a better stability of cannabinoids in oil extracts rather than in alcohol or in decoction …”

Section: Introductionmentioning

confidence: 99%

Cannabinoids concentration variability in cannabis olive oil galenic preparations

Carcieri

Tomasello

Simiele

et al. 2018

Journal of Pharmacy and Pharmacology

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Objectives Knowledge of the exact concentration of active compounds in galenic preparations is crucial to be able to ensure their quality and to properly administer the prescribed dose. Currently, the need for titration of extracts is still debated. Considering this, together with the absence of a standard preparation method, the aim of this study was to evaluate cannabinoids concentrations variability in galenic olive oil extracts, to evaluate the interlot and interlaboratory variability in the extraction yield and in the preparation composition. , Bedroliteâ (5 g/50 ml), these were THC 82%, THC 53% and CBD 91%, THC 58% and CBD 59%, respectively. The median extraction yields were greater than 75% for all preparations.Conclusions Our results highlighted a wide variability in THC and CBD concentrations that justify the need for titration and opens further questions about other pharmaceutical preparations without regulatory indication for this procedure.

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“…Enrichment of active ingredients for manufacture of Cannabis -based drugs can be achieved using aqueous (decoction) [39], organic (e.g., ethanolic) [40], supercritical fluid [41, 42] and edible plant oil-based extraction [43] (Fig. 2), with aqueous being the least appropriate given the low solubility of cannabinoids in water [44, 45]. Purification of the botanical drug substance may involve repeated extraction, chromatographic separation, distillation, as well as winterisation, whereby non-target lipid-soluble materials, such as waxes, are removed by filtration at –20°C [46].…”

Section: Cannabis Drug Formsmentioning

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. The following sub-sections discuss a validation scheme compliant with the ICH Q2 (R1) guideline and highlight generalised validation parameters for the quantification of cannabinoids within CME, with emphasis on potential challenges for fulfilling these criteria.…”

Section: Validation Characteristics For Analytical Proceduresmentioning

confidence: 99%

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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Evaluation of cannabinoids concentration and stability in standardized preparations of cannabis tea and cannabis oil by ultra-high performance liquid chromatography tandem mass spectrometry

Abstract: As the first and most important aim of the different cannabis preparations is to guarantee therapeutic continuity in treated individuals, a strictly standardized preparation protocol is necessary to assure the availability of a homogeneous product of defined stability.

Cited by 109 publications

References 21 publications

Patient-Reported Symptom Relief Following Medical Cannabis Consumption

Patient-Reported Symptom Relief Following Medical Cannabis Consumption

Cannabinoids concentration variability in cannabis olive oil galenic preparations

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

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