Development of Standard Operating Protocols for the Optimization of Cannabis-Based Formulations for Medical Purposes

Baratta, Francesca; Simiele, Marco; Pignata, Irene; Enri, Lorenzo Ravetto; Torta, Riccardo; Luca, Anna De; Collino, Massimo; D’Avolio, Antonio; Brusa, Paola

doi:10.3389/fphar.2019.00701

Cited by 18 publications

(32 citation statements)

References 15 publications

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“…Consequently, decoction induced a greater feeling of hunger and drowsiness than the oil preparation [ 7 ]. In any case, great interindividual variability in cannabinoids kinetics and physiological and subjective effects was observed, especially due to the difficult standardization of herbal preparations and low absorption of oral administrations [ 9 , 10 , 11 , 12 ], as previously reported in different studies on adult and young patients administered with oral medical cannabis [ 13 , 14 ].…”

Section: Introductionmentioning

confidence: 97%

Disposition of Phytocannabinoids, Their Acidic Precursors and Their Metabolites in Biological Matrices of Healthy Individuals Treated with Vaporized Medical Cannabis

et al. 2021

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Inhalation by vaporization is a useful application mode for medical cannabis. In this study, we present the disposition of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), their acidic precursors, and their metabolites in serum, oral fluid, and urine together with the acute pharmacological effects in 14 healthy individuals treated with vaporized medical cannabis. THC and CBD peaked firstly in serum and then in oral fluid, with higher concentrations in the first biological matrices and consequent higher area under the curve AUCs. Acidic precursors Δ-9-tetrahydrocannabinolic acid A (THCA) and cannabidiolic acid (CBDA) showed a similar time course profile but lower concentrations due to the fact that vaporization partly decarboxylated these compounds. All THC and CBD metabolites showed a later onset with respect to the parent compounds in the absorption phase and a slower decrease to baseline. In agreement with serum kinetics, THC-COOH-GLUC and 7-COOH-CBD were the significantly most excreted THC and CBD metabolites. The administration of vaporized medical cannabis induced prototypical effects associated with the administration of cannabis or THC in humans, with a kinetic trend overlapping that of parent compounds and metabolites in serum. The pharmacokinetics of cannabinoids, their precursors, and their metabolites in biological fluids of individuals treated with vaporized medical cannabis preparations showed a high interindividual variability as in the case of oral medical cannabis decoction and oil. Inhaled medical cannabis was absorbed into the organism earlier than decoction and oil. Cannabinoids reached higher systemic concentrations, also due to the fact that the acid precursors decarboxylated to parent cannabinoids at high temperatures, and consequently, the physiological and subjective effects occurred earlier and resulted with higher intensity. No serious adverse effects were observed.

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Section: Introductionmentioning

confidence: 97%

Disposition of Phytocannabinoids, Their Acidic Precursors and Their Metabolites in Biological Matrices of Healthy Individuals Treated with Vaporized Medical Cannabis

et al. 2021

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“…In Italy from November 2015, cannabis may be prescribed with medical prescription. Italian legislation has approved regulations regarding the administration of medical Cannabis for specific medical conditions (pain therapy, chemotherapy/ radiotherapy-induced nausea and vomiting, cachexia, anorexia, cancer patients, AIDS, glaucoma, and Tourette's syndrome (Baratta et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

“…In Italy from November 2015, can issue licenses for cultivation, production, possession, and use, and herbal cannabis may be prescribed with medical prescription. Italian legislation has recently approved medical use of Cannabis for some conditions such as pain control, chemotherapy-and radiotherapy-induced nausea and vomiting treatment, appetite stimulation in patients affected by cachexia, anorexia, cancer, or AIDS and for other pathologies, such as glaucoma and Tourette's syndrome (Baratta et al, 2019).…”

Section: European (Ema) and Italian Legislation (Aifa) Us (Fda)mentioning

confidence: 99%

Cannabidiol Treatment for Refractory Epilepsies in Pediatrics

et al. 2020

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Cannabis extracts in oil are becoming increasingly available, and, during the last years, there has been growing public and scientific interest about therapeutic properties of these compounds for the treatment of several neurologic diseases, not just epilepsy. The discovered role of the endocannabinoid system in epileptogenesis has provided the basis to investigate the pharmacological use of exogenously produced cannabinoids, to treat epilepsy. Although, physicians show reluctance to recommend Cannabis extracts given the lack of high-quality safety available data, from literature data cannabidiol (CBD) results to be a promising and safe anticonvulsant drug with low side-effect. In particular, according to early studies, CBD can reduce the frequency of seizures and lead to improvements in quality of life in children affected by refractory epilepsy. So, for these reasons, the detailed study of the interactions between CBD and anticonvulsant drugs (AEDs) administered simultaneously in polytherapy, is arousing increasing interest, to clarify and to assess the incidence of adverse effects and the relation between dose escalation and quality of life measures. To date, in pediatric age, CBD efficacy and safety is not supported by well-designed trials and strong scientific evidence are not available. These studies are either retrospective or small-scale observational and only during the last years Class I evidence data for a pure form of CBD have been available, as demonstrated in placebo-controlled RCTs for patients affected by Lennox-Gastaut syndrome and Dravet syndrome. It is necessary to investigate CBD safety, pharmacokinetics and interaction with other AEDs alongside performing double-blinded placebo-controlled trials to obtain conclusive data on its efficacy and safety in the most frequent epilepsies in children, not just in the epileptic encephalopathy. This review was aimed to revise the available data to describe the scientific evidence for CBD in Pediatric Epilepsies.

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“…All these methods were used by pharmacists, based on medical prescriptions, to obtained cannabis oils by different varieties of medicinal grade plant material: the Dutch Bedrocan, Bediol, Bedrolite, and the Italian FM2. After decarboxylation, where planned, the cannabis decoctions in oil were mainly carried out with a weight-to-volume ratio between plant material and oil of 1: 10 (usually 5 g in 50 ml) (Baratta et al, 2019). Mainly, pharmacopeia grade olive oil, usually virgin or refined according to the European Pharmacopoeia (Ph.…”

Section: Galenic Preparationsmentioning

confidence: 99%

Phytocannabinoids Profile in Medicinal Cannabis Oils: The Impact of Plant Varieties and Preparation Methods

et al. 2020

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Cannabis (Cannabis sativa L.) is a highly promising medicinal plant with well-documented effectiveness and growing use in the treatment of various medical conditions. Cannabis oils are mostly used in galenic preparations, due to their easy adjustment of the administration dose, together with the enhanced bioavailability of its active compounds. As stated by the Italian Law (9/11/2015, 279 Official Gazette), “to ensure the quality of the oil-based cannabis preparation, the titration of the active substance(s) should be carried out.” This study aims to represent the Italian panorama of cannabis oils, which were analyzed (8,201) to determine their cannabinoids content from 2017 to 2019. After application of the exclusion criteria, 4,774 standardized cannabis oils were included, which belong to different medicinal cannabis varieties and prepared according to different extraction methods. The concentration of the principal cannabinoids was taken into account dividing samples on the basis of the main extraction procedures and cannabis varieties. According to this analysis, the most substantial variations should be attributed to different cannabis varieties rather than to their extraction protocols. This study may be the starting point of preparatory pharmacists to assess the correct implementation of the preparation procedures and the quality of the extracts.

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Development of Standard Operating Protocols for the Optimization of Cannabis-Based Formulations for Medical Purposes

Cited by 18 publications

References 15 publications

Disposition of Phytocannabinoids, Their Acidic Precursors and Their Metabolites in Biological Matrices of Healthy Individuals Treated with Vaporized Medical Cannabis

Disposition of Phytocannabinoids, Their Acidic Precursors and Their Metabolites in Biological Matrices of Healthy Individuals Treated with Vaporized Medical Cannabis

Cannabidiol Treatment for Refractory Epilepsies in Pediatrics

Phytocannabinoids Profile in Medicinal Cannabis Oils: The Impact of Plant Varieties and Preparation Methods

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