Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications

Bettiol, Alessandra; Lombardi, Niccolò; Crescioli, Giada; Maggini, Valentina; Mugelli, Alessandro; Baronti, Roberto

doi:10.3389/fphar.2018.01543

Cited by 22 publications

(15 citation statements)

References 21 publications

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“…Medical use of cannabis is authorised in Italy and reimbursed within the National Health System for selected medical conditions (as reported in the Official Gazette no. 279 from 30 November 2015): (i) analgesia in diseases involving spasticity associated with pain (multiple sclerosis, spinal cord injury) resistant to conventional therapies; (ii) analgesia in chronic pain (with particular reference to neurogenic pain) in which treatment with nonsteroidal anti‐inflammatory drugs or with cortisone or opioid drugs has proved to be ineffective; (iii) anti‐motion sickness and antiemetic effect in nausea and vomiting, caused by chemotherapy, radiotherapy, human immunodeficiency virus therapies, which cannot be obtained with traditional treatments; (iv) appetite stimulating effect in cachexia, anorexia, loss of appetite in cancer patients or patients with AIDS and in anorexia nervosa, which cannot be obtained with standard treatments; (v) hypotensive effect in glaucoma resistant to conventional therapies; (vi) reduction of involuntary body and facial movements in Tourette syndrome, which cannot be achieved with standard treatments …”

Section: Introductionmentioning

confidence: 99%

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

Crescioli

Lombardi

Bettiol

et al. 2020

Brit J Clinical Pharma

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Aims: Despite a significant increase in using cannabis for medical purposes, current evidence on its safety in real-world clinical practice is still poorly characterised. By a case-by-case analysis of spontaneous reports of suspected adverse events (AEs) collected in Tuscany within the Italian Phytovigilance database, the aim of the present study was to describe AEs occurred in patients exposed to medical cannabis. Methods: We evaluated all reports of cannabis-related suspected AEs collected within the Phytovigilance database up to December 2018. Information regarding cannabis therapy, patient's demographic and clinical characteristics, concomitant medications, AE description according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, AE seriousness and AE outcome, were collected. The causality assessment was performed following World Health Organisation-Uppsala Monitoring Centre criteria.Results: Fifty-three cannabis-related AE reports were analysed. The majority of patients were females (77.3%), with a mean age of 61.9 years. Thirty-nine (73.6%) cases were defined as nonserious and the majority of them (86.9%) showed a complete resolution or improvement. Forty-six (86.8%) cases were judged as probably related to cannabis consumption. The most frequently reported system organ class was psychiatric and nervous system disorders, and a potential drug-drug interaction was present in 16 cases. Conclusion:Cannabis was generally well tolerated and the majority of AEs were mild and transient. Our analysis highlighted important safety issues for clinical practice, in particular the need for an accurate prescription monitoring during the titration phase, particularly in the presence of concomitant medications. K E Y W O R D Sadverse drug reactions, clinical pharmacology, drug safety, general practice, medical cannabis Giada Crescioli and Niccolò Lombardi are co-first authors.

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Section: Introductionmentioning

confidence: 99%

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

Crescioli

Lombardi

Bettiol

et al. 2020

Brit J Clinical Pharma

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“…On the other hand, much research has focused attention on the development of analytical methods based on liquid chromatography coupled to UV detection (HPLC-UV) together with mass spectrometry (LC-MS/MS and HRMS) to quantify targeted and untargeted cannabinoids, terpenes, and oxidation products, such as aldehydes and ketones, both in inflorescences and derived oils at the ppb level [ 9 , 10 , 11 , 23 , 24 , 25 , 26 , 27 , 28 ] as summarized in Table 1 .…”

Section: Introductionmentioning

confidence: 99%

Impact of Lipid Sources on Quality Traits of Medical Cannabis-Based Oil Preparations

Ramella¹,

Roda

Pavlović

et al. 2020

Molecules

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The feasibility of the use of two lipid sources and their impact on the cannabinoid profile, terpene fingerprint, and degradation products in medical cannabis oil preparations during 3 months of refrigerated storage time were investigated. LCHRMS-Orbitrap® and HS-SPME coupled to GC-MS for the investigation of targeted and untargeted cannabinoids, terpenes, and lipid degradation products in Bedrocan® and Bediol® macerated oils were used as analytical approaches. As regards the cannabinoid trend during 90 days of storage, there were no differences between PhEur-grade olive oil (OOPH) and medium-chain triglycerides oil (MCT oil) coupled to a good stability of preparations for the first 60 days both in Bedrocan® and Bediol® oils. MCT lipid source extracted a significant concentration of terpenes compared to olive oil. Terpenes showed a different scenario since MCT oil displayed the strongest extraction capacity and conservation trend of all compounds during the shelf life. Terpenes remained stable throughout the entire storage period in MCT formulations while a significant decrease after 15 and 30 days in Bediol® and Bedrocan® was observed in olive oil. Therefore, MCT oil could be considered a more suitable lipid source compared to olive oil involved in the extraction of medical cannabis for magistral preparations.

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“…Citti et al [36] used 100 μL (10 times higher) of cannabis oil, and the reported LLOQs for Δ 9 -THC, CBD, and CBN were greater than that presented herein. Bettiol et al [37] and Deida et al [38] applied 40 μL (4 times higher) of cannabis oil and reported LLOQs of 1.0 μg/mL for Δ 9 -THC, CBD, and CBN. The mentioned papers report higher LLOQs than ours when analyses were carried out using a LC-DAD or LC-MS system.…”

Section: Resultsmentioning

confidence: 99%

Quantification of Cannabinoids in Cannabis Oil Using GC/MS: Method Development, Validation, and Application to Commercially Available Preparations in Argentina

Fernández

Carreras

Larcher

et al. 2020

Planta Medica International Open

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The medicinal use of cannabis oil is increasing all over the world. Few analytical methods for the quantification of cannabinoids have been validated using internationally accredited guidelines. This work describes the development and validation of a selective and sensitive gas chromatography-mass spectrometry method for the qualitative analysis of the main cannabinoids, namely cannabidiolic acid, tetrahydrocannabinolic acid, cannabigerol, and cannabichromene as well as quantitative determination of cannabidiol, Δ9-tetrahydrocannabinol, and cannabinol, present in cannabis oils. The method was fully validated according to Food and Drug Administration and International Conference on Harmonization guidelines. A linear range of 0.1–30 μg/mL was obtained for CBD and Δ9-THC and 0.034–11.7 μg/mL for CBN, presenting determination coefficients above 0.99. The lower limits of quantification ranged from 0.034 to 0.1 μg/mL. The intra- and inter-day precision, calculated in terms of relative standard deviation, were 3.9–13.8 and 4.7–14.1%, respectively. Extraction efficiency at lower limits of quantification was 95–103%. Verification of method validity was performed with authentic cannabis oil samples. To our knowledge, this is the first method available in Argentina, validated according to international guidelines, for quantification of CBD, Δ9-THC, and CBN in cannabis oil. The primary application of this method is to differentiate between cannabis oils with high or low content of Δ9-THC, CBD, or mixed Δ9-THC/CBD. This is of fundamental importance for the patient and so that the physicians can carry out a suitable therapy.

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Galenic Preparations of Therapeutic Cannabis sativa Differ in Cannabinoids Concentration: A Quantitative Analysis of Variability and Possible Clinical Implications

Cited by 22 publications

References 21 publications

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

Impact of Lipid Sources on Quality Traits of Medical Cannabis-Based Oil Preparations

Quantification of Cannabinoids in Cannabis Oil Using GC/MS: Method Development, Validation, and Application to Commercially Available Preparations in Argentina

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