Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of cancer treatment, affecting many patients. Cannabinoid agonists, such as nabilone and Δ9-tetrahydrocannabinol (THC), the main psychoactive component of Cannabis sativa L., have shown efficacy as antiemetics. Here, we report the case of Michael Roberts (MR), who we believe is the first British patient reimbursed by the National Health Service (NHS) England for the cost of medicinal cannabis flowers to manage CINV. Medical data were obtained from NHS records and individual funding request (IFR) forms. Patient-reported outcome measures (PROMs) were collected using validated questionnaires as part of the standard of care at the specialized private clinics where the prescription of medicinal cannabis was initiated. The patient presented with rectosigmoid adenocarcinoma with lung metastases. He received FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy and underwent an emergency Hartmann\'s procedure with subsequent second-line FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy and lung ablation. MR reported severe nausea and vomiting associated with the initial FOLFIRI treatment. Antiemetics metoclopramide and aprepitant demonstrated moderated efficacy. Antiemetics ondansetron, levomepromazine, and nabilone were associated with intolerable side effects. Inhalation of THC-predominant cannabis flowers in association with standard medication improved CINV, anxiety, sleep quality, appetite, overall mood, and quality of life. Our results add to the available evidence suggesting that medicinal cannabis flowers may offer valuable support in cancer palliative care integrated with standard-of-care oncology treatment. The successful individual funding request in this case demonstrates a pathway for other patients to gain access to these treatments, advocating for broader awareness and integration of cannabis-based medicinal products in national healthcare services.

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In this study, the optimal setup of supercritical fluid extraction (SFE) was designed and developed, leading to the quantitation of 11 distinct cannabinoids (cannabidivann (CBDV), tetrahydrocannabivann (THCV), cannabidiol (CBD), cannabigerol (CBG) cannabidiolic acid (CBDA), cannabigerolic acid (CBGA), cannabinol (CBN), delta 9-tetrahydrocannabinol (Δ9-THC), delta 8-tetrahydrocannabinol (Δ8-THC), cannabichomere (CBC) and delta 9-tetrahydrocannabinol acid (THCA-A)) extracted from the flowers of medicinal cannabis (sp. Sativa). Supercritical carbon dioxide (scCO2) extraction was performed at 37 °C, a pressure of 250 bar with the maximum theoretical density of CO2 (893.7 kg/m3), which generated the highest yield of cannabinoids from the flower-derived extract. Additionally, a cold separator (separating chamber) was used and positioned immediately after the sample containing chamber to maximize the yield. It was also found that successive washing of the extract with fresh scCO2 further increased yields. Ultra-high performance liquid chromatography coupled with DAD (uHPLC-DAD) was used to develop a method for the quantification of 11 cannabinoids. The C18 stationary phase was used in conjunction with a two solvent system gradient program resulting in the acquisition of the well-resolved chromatogram over a timespan of 32 min. The accuracy and precision of isolated cannabinoids across inter-and intra-day periods were within acceptable limits (<±15%). The assay was also fully validated and deemed sensitive from linearity, LOQ, and LOD perspective. The findings of this body of work are expected to facilitate improved conditions for the optimal extraction of select cannabinoids using scCO2, which holds promise in the development of well-characterized medicinal cannabis formulations. As to our best knowledge, this is the first study to report the uHPLC quantification method for the analysis of 11 cannabinoids from scCO2 extract in a single run with more than 1 min peak separation.

Worldwide, a highly dynamic development of regulatory strategies for cannabis flowers and cannabis-derived products for medical use can be observed. Conditions laid down in the Single Convention on Narcotic Drugs are basic, and implementation in countries is diverse.As early as 1998, the Netherlands was the first Member State of the European Union (EU) to establish a strategy to provide patient access to cannabis for medical use. Since then, more and more Member States of the European Union have facilitated access to cannabis for medical use. A comparable development has taken place outside Europe. This article describes the current situation in the Netherlands and presents selected highlights of developments within and outside Europe to demonstrate the broad spectrum of strategies. Key parameters are identified that should be considered when changing or amending regulatory frameworks on cannabis for medical use. In addition to the establishment of adequate regulatory frameworks, there is a substantial need to generate adequate scientific data.

Herbal drugs and extracts, like all pharmaceutical starting materials used in the manufacture of medicinal products, must have an appropriate pharmaceutical quality. Corresponding quality standards are described in the individual monographs of the pharmacopoeia according to § 55 of the German Drug Law. This includes information on ingredients and active substance content, among other things. This article describes the development of the Cannabis Flower Monograph for the German Pharmacopoeia (DAB) and the quality requirements and storage conditions contained therein. The state of development of monographs for the European Pharmacopoeia is also presented.After it was announced that there would be new legal regulations for the medical use of cannabis flowers and cannabis extracts, the first work on the cannabis flower monograph for the DAB began as early as 2015. First, a monograph on cannabis flowers was published in May 2016 in the German Drug Codex (DAC). The monograph was replaced in May 2017 by the publication of the DAB monograph. A revised version of the DAB monograph has been in force since April 2018 as a national quality standard.A harmonised cannabis flower monograph for the European Pharmacopoeia is currently being prepared to replace national quality standards. In addition, the German Pharmacopoeia and subsequently the European Pharmacopoeia develops monographs for preparations from cannabis flowers. In future, harmonised monographs in the European Pharmacopoeia will make it possible to avoid multiple testing according to the respective national standards and to facilitate analyses in laboratories and pharmacies.