Abstract
Current legislation in Italy provides that medical Cannabis may be administered orally or by inhalation. One of the fundamental criteria for the administration of oral formulations is that they deliver a known consistent quantity of the active ingredients to ensure uniform therapies leading to the optimisation of the risks/benefits. In 2018, our group developed an improved Cannabis oil extraction technique. The objective of the present work was to carry out a stability study for the oil extracts obtained by this method. Furthermore, in order to facilitate the consumption of the prescribed medical Cannabis therapy by patients, a standard procedure was defined for the preparation of a single-dose preparation for oral use (hard capsules) containing the oil extract; thereafter, the quality and stability were evaluated. The hard capsules loaded with the oil extract were analysed and found to be uniform in content. The encapsulation process did not alter the quantity of the active molecule present in the oil. The stability tests yielded excellent results. Since the capsule dosage form is easily transported and administered, has pleasant organoleptic properties and is stable at room temperature for extended periods of time, this would facilitate the adherence to therapy by patients in treatment.
Highlights
Before the last century, when it became illegal in most Countries, Cannabis was widely used in medicine
Considering that oils have received considerable attention due to their easier dose management during the treatment period, but their organoleptic characteristics are unpleasant, in order to facilitate the consumption of the prescribed medical Cannabis therapy by a patient in treatment, a standard procedure was defined for the preparation of a single-dose preparation for oral use using the oil-based formulation
The stability has been the same for the capsules fitted with different amounts of the β-4 oils: the results revealed that the encapsulation process has no effect on the oils
Summary
Before the last century, when it became illegal in most Countries, Cannabis was widely used in medicine. There has been a resurgence in support for the legalisation of cannabinoids for medical use as a result of media attention as well as expectations of their efficacy, albeit, this is not always supported by scientific evidence [3,4,5]. The phytocomplex of the Cannabis plant contains over 500 different molecules, of which approximately a hundred belong to the cannabinoid chemical class; among these, small differences in molecular structure may induce widely different effects [6]. The molecules of greatest pharmacological interest from the point of view of their effects are the decarboxylated forms of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) as these are absorbed in the intestine [7]. The determination of the quantities of these compounds present in medications to be administered to patients is a fundamental prerequisite
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