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New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?

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A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Physical Pharmacy and Formulation".

Deadline for manuscript submissions: 30 April 2024 | Viewed by 28287

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Special Issue Editors

Dr. Paola Brusa

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Department of Drug Science and Technology, University of Turin, Turin, Italy
Interests: regulatory science; health policy; medicinal products; compounding; drug delivery systems; international health cooperation
Special Issues, Collections and Topics in MDPI journals

Dr. Francesca Baratta

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Department of Drug Science and Technology, University of Turin, Turin, Italy
Interests: regulatory science; health policy; medicinal products; compounding; drug delivery systems, international health cooperation
Special Issues, Collections and Topics in MDPI journals

Prof. Dr. Fabio Firenzuoli

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Research and Innovation Center in Phytotherapy and Integrated Medicine (CERFIT), Careggi University Hospital, Via delle Oblate 4, 50141 Florence, Italy
Interests: herbal medicine; clinical phytotherapy; medicinal plants; phytochemistry; herbal pharmacovigilance

Dr. Valentina Maggini

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1. Research and Innovation Center in Phytotherapy and Integrated Medicine, Careggi University Hospital, Florence, Italy
2. Specialist Trainee in Clinical Pharmacology and Toxicology, Guest Researcher at Department of Biology, University of Florence, 50141 Florence, Italy
Interests: antimicrobial activity of phytocomplexes; essential oils; multidrug-resistance; plant-microbe interactions; in vitro plant models

Special Issue Information

Dear Colleagues,

Before it became illegal in most parts of the world in the previous century, cannabis was widely used in medicine. In recent years, following the legalization of cannabinoids for medical use in various countries, there has been an exponential increase in its use and a growing interest in this field. Therefore, scientific research on medical cannabis has rapidly advanced, and the ever-increasing number of experimental studies suggests that phytocannabinoids could be useful for various pathological conditions.

The phytocomplex of cannabis plants is composed of over 500 different constituents, of which about a hundred belong to the class of cannabinoids, where minimal differences in their structure can induce very different effects. The molecules of greatest interest for their pharmacological activity are THC and CBD, but recent studies have also focused on the effects of other molecules, such as cannabigerols, cannabichromenes, and also terpenes.

This Special Issue of Pharmaceutics focuses on articles and reviews relating to extractive or advanced formulations based on cannabis for medical use, currently under study for therapeutic purposes. Studies relating to the development of galenic formulations will also be considered.

We look forward to receiving your contributions.

Dr. Paola Brusa
Dr. Francesca Baratta
Prof. Dr. Fabio Firenzuoli
Dr. Valentina Maggini
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

cannabis
formulations
medical use
cannabinoids
terpenes
compounding

Published Papers (6 papers)

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Research

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15 pages, 1496 KiB

Open AccessArticle

Digital Technologies Applied to Control the One-Step Process of Cannabis Olive Oil Preparations

by Paolo Bongiorno, Antonio Lopalco, Antonella Casiraghi, Antonio Spennacchio, Alessandro Pitruzzella, Angela Assunta Lopedota, Paola Minghetti and Nunzio Denora

Pharmaceutics 2023, 15(3), 870; https://doi.org/10.3390/pharmaceutics15030870 - 08 Mar 2023

Cited by 1 | Viewed by 1975

Abstract

The reproducibility of an extemporaneous preparation is an essential condition for guaranteeing the quality, efficacy, and safety of the medicinal product. This study aimed to develop a controlled one-step process for cannabis olive oil preparations by applying digital technologies. For this purpose, the chemical profile of cannabinoid contents in oil extracts of Bedrocan, FM2, and Pedanios varieties obtained with the already in use method, proposed by the Italian Society of Compounding Pharmacists (SIFAP), was compared with two new methods, specifically the Tolotto Gear^® extraction method (TGE) and the Tolotto Gear^® extraction method preceded by a pre-extraction procedure (TGE-PE). HPLC analyses showed that the concentration of THC using cannabis flos with a high THC content (over 20% w/w) was always higher than 21 mg/mL for the Bedrocan variety and close to 20 mg/mL for the Pedanios variety when applying TGE, while with TGE-PE, the THC concentration was higher than 23 mg/mL for the Bedrocan variety. For the FM2 variety, the amounts of THC and CBD in the oil formulations obtained using TGE were higher than 7 mg/mL and 10 mg/mL, respectively, and for TGE-PE, the concentrations of THC and CBD were higher than 7 mg/mL and 12 mg/mL, respectively. GC-MS analyses were performed to define the terpene contents in the oil extracts. The samples of Bedrocan flos extracted with TGE-PE displayed a distinctive profile, highly rich in terpenes and devoid of oxidized volatile products. Thus, TGE and TGE-PE allowed performing a quantitative extraction of cannabinoids and increasing the total mono-di-tri terpenes and sesquiterpene concentrations. The methods were repeatable and applicable to any quantity of raw material, preserving the phytocomplex of the plant. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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13 pages, 922 KiB

Open AccessArticle

Ultrasound-Assisted Extraction of Cannabinoids from Cannabis Sativa for Medicinal Purpose

by Antonella Casiraghi, Andrea Gentile, Francesca Selmin, Chiara Grazia Milena Gennari, Eleonora Casagni, Gabriella Roda, Gloria Pallotti, Pierangela Rovellini and Paola Minghetti

Pharmaceutics 2022, 14(12), 2718; https://doi.org/10.3390/pharmaceutics14122718 - 05 Dec 2022

Viewed by 2315

Abstract

Over the past 20 years, the interest in Cannabis oily extracts for medicinal use compounded in pharmacy has consistently grown, along with the need to have preparations of adequate quality. Hot maceration (M) is the most frequently used method to compound oily solutions. In this work, we systematically studied the possibility of using an ultrasonic homogenizer and a sonotrode (US) as an alternative extraction method. Oily solutions were prepared using two available varieties of Cannabis for medicinal use, called FM2 and Bedrocan. All preparations resulted with an equivalent content in CBD and THC, with the advantage of a faster process using US. In particular, 10 min sonication at the amplitude optimized for the sonotrode used (2 or 7 mm) provides not statistically different total Δ9-tetrahydrocannabinol (M-FM2: 0.26 ± 0.02 % w/w; US-FM2: 0.19 ± 0.004 % w/w; M-Bedrocan: 1.83 ± 0.17 % w/w; US-Bedrocan: 1.98 ± 0.01 % w/w) and total cannabidiol (M-FM2: 0.59 ± 0.04 % w/w; US-FM2: 0.58 ± 0.01 % w/w) amounts extracted in refined olive oil. It can therefore be confirmed that sonotrode is an efficient and fast extraction technique and its use is without negative consequence on the solvent properties. Despite DSC evidencing that both maceration and sonication modify the T_onset and enthalpy of the event at about −10 °C, the qualitative characteristics of the oil remained constant for the two treatments and similar to the starting material. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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18 pages, 2669 KiB

Open AccessArticle

Development of Stable Nano-Sized Transfersomes as a Rectal Colloid for Enhanced Delivery of Cannabidiol

by Thope Moqejwa, Thashree Marimuthu, Pierre P. D. Kondiah and Yahya E. Choonara

Pharmaceutics 2022, 14(4), 703; https://doi.org/10.3390/pharmaceutics14040703 - 25 Mar 2022

Cited by 29 | Viewed by 4273

Abstract

Current cannabidiol (CBD) formulations are challenged with unpredictable release and absorption. Rational design of a rectal colloid delivery system can provide a practical alternative. In this study the inherent physiochemical properties of transferosomes were harnessed for the development of a nano-sized transfersomes to yield more stable release, absorption, and bioavailability of CBD as a rectal colloid. Transfersomes composed of soya lecithin, cholesterol, and polysorbate 80 were synthesized via thin film evaporation and characterized for size, entrapment efficiency (%), morphology, CBD release, ex vivo permeation, and physicochemical stability. The optimized formulation for rectal delivery entrapped up to 80.0 ± 0.077% of CBD with a hydrodynamic particle size of 130 nm, a PDI value of 0.285, and zeta potential of −15.97 mV. The morphological investigation via SEM and TEM revealed that the transfersomes were spherical and unilamellar vesicles coinciding with the enhanced ex vivo permeation across the excised rat colorectal membrane. Furthermore, transfersomes improved the stability of the encapsulated CBD for up to 6 months at room temperature and showed significant promise that the transfersomes promoted rectal tissue permeation with superior stability and afforded tunable release kinetics of CBD as a botanical therapeutic with inherent poor bioavailability. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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12 pages, 2139 KiB

Open AccessEditor’s ChoiceArticle

Cannabis-Based Oral Emulsion for Medical Purposes to Meet the Needs of Patients: Formulation, Quality and Stability

by Francesca Baratta, Elena Peira, Carola Maza, Marina Gallarate and Paola Brusa

Pharmaceutics 2022, 14(3), 513; https://doi.org/10.3390/pharmaceutics14030513 - 25 Feb 2022

Cited by 2 | Viewed by 2414

Abstract

Current Italian legislation provides that medical Cannabis can be administered orally as an extract if it has been titrated to determine the concentration of active molecules. In this context, there is a need to provide known and adequate quantities of active ingredients in order to guarantee uniform therapies that lead to the optimization of risks/benefits. This is fundamental considering that the limited availability on the market of registered Cannabis-based products for medical use means that prescribed therapies are usually prepared as galenic preparations. Consequently, the preparation procedures must be consistent with the instrumentation usually present in the laboratories of community pharmacies. In this context, the purpose of this work was to standardize the preparation procedure for oil-in-water (O/W) emulsions to exploit advantages in terms of ease of administration and dosage adjustment, but also to ensure the palatable organoleptic characteristics of the finished product. For the formulations being studied, in addition to the quality according to the directives set out in the European Pharmacopoeia, the stability was evaluated to assure adequate validity for therapeutic uses. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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Graphical abstract

16 pages, 4004 KiB

Open AccessArticle

An Optimized Terpene Profile for a New Medical Cannabis Oil

by Valentina Maggini, Lorenzo Calvi, Tommaso Pelagatti, Eugenia Rosaria Gallo, Celine Civati, Carlo Privitera, Flavio Squillante, Paolo Maniglia, Domenico Di Candia, Roberto Spampatti and Fabio Firenzuoli

Pharmaceutics 2022, 14(2), 298; https://doi.org/10.3390/pharmaceutics14020298 - 27 Jan 2022

Cited by 4 | Viewed by 5992

Abstract

The purpose of this analytical study was to develop an advanced formulation of medical Cannabis oil (MCO) comparing the chemical profile of different extracts obtained with two existing methods (SIFAP and CALVI) and one original upgraded (CERFIT) method. Preparation methods were applied with varying solvent, temperature, and duration of the decarboxylation and extraction steps. HPLC-MS/MS TSQ and GC/FID-HS analyses were performed to investigate cannabinoid and terpene contents in the three oil extracts. Cannabinoids profile remained comparable between the formulations. CERFIT extracts exhibited a superior quantity of total terpene hydrocarbon forms (e.g., limonene and α-pinene) with no degradation occurrence (i.e., oxidized terpenes not quantifiable). Thus, this new method optimized the phytochemical profile of the MCO presenting a value opportunity to obtain a standardized high-level therapeutic product. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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Review

Jump to: Research

23 pages, 905 KiB

Open AccessReview

“The Two Sides of the Same Coin”—Medical Cannabis, Cannabinoids and Immunity: Pros and Cons Explained

by Mona Khoury, Idan Cohen and Gil Bar-Sela

Pharmaceutics 2022, 14(2), 389; https://doi.org/10.3390/pharmaceutics14020389 - 10 Feb 2022

Cited by 17 | Viewed by 8660

Abstract

Cannabis, as a natural medicinal remedy, has long been used for palliative treatment to alleviate the side effects caused by diseases. Cannabis-based products isolated from plant extracts exhibit potent immunoregulatory properties, reducing chronic inflammatory processes and providing much needed pain relief. They are a proven effective solution for treatment-based side effects, easing the resulting symptoms of the disease. However, we discuss the fact that cannabis use may promote the progression of a range of malignancies, interfere with anti-cancer immunotherapy, or increase susceptibility to viral infections and transmission. Most cannabis preparations or isolated active components cause an overall potent immunosuppressive impact among users, posing a considerable hazard to patients with suppressed or compromised immune systems. In this review, current knowledge and perceptions of cannabis or cannabinoids and their impact on various immune-system components will be discussed as the “two sides of the same coin” or “double-edged sword”, referring to something that can have both favorable and unfavorable consequences. We propose that much is still unknown about adverse reactions to its use, and its integration with medical treatment should be conducted cautiously with consideration of the individual patient, effector cells, microenvironment, and the immune system. Full article

(This article belongs to the Special Issue New Perspectives for the Administration of Cannabis for Medical Use: From Traditional to Advanced Formulations. What Next?)

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