Difference between revisions of "Journal:Development of standard operating protocols for the optimization of Cannabis-based formulations for medical purposes"
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To date, studies on the therapeutic efficacy of ''Cannabis'' in certain pathologies have yielded results that are, at best, contradictory and, generally, inconclusive given that the studies were carried out on inhomogeneous populations, used differing extraction processes, and administered differing dosages.<ref name="Bar-LevMedical18">{{cite journal |title=Medical cannabis: Aligning use to evidence-based medicine approach |journal=British Journal of Clinical Pharmacology |author=Bar-Lev, S.L.; Abuhasira, R.; Novack, V. |volume=84 |issue=11 |pages=2458–62 |year=2018 |doi=10.1111/bcp.13657 |pmid=29859014 |pmc=PMC6177696}}</ref> Moreover, the experiments were performed without proper control procedures and were administered by different routes. These uncertainties stem in part from legislative restrictions that, over time, have severely hindered the performance of rigorous clinical studies under controlled and comparable conditions. The legalization of ''Cannabis'' for medical use can pave the way for the gathering of reliable clinical and epidemiological data, which are fundamental for a clear definition of the clinical efficacy and the inherent risks, in a medical environment, of ''Cannabis''. | To date, studies on the therapeutic efficacy of ''Cannabis'' in certain pathologies have yielded results that are, at best, contradictory and, generally, inconclusive given that the studies were carried out on inhomogeneous populations, used differing extraction processes, and administered differing dosages.<ref name="Bar-LevMedical18">{{cite journal |title=Medical cannabis: Aligning use to evidence-based medicine approach |journal=British Journal of Clinical Pharmacology |author=Bar-Lev, S.L.; Abuhasira, R.; Novack, V. |volume=84 |issue=11 |pages=2458–62 |year=2018 |doi=10.1111/bcp.13657 |pmid=29859014 |pmc=PMC6177696}}</ref> Moreover, the experiments were performed without proper control procedures and were administered by different routes. These uncertainties stem in part from legislative restrictions that, over time, have severely hindered the performance of rigorous clinical studies under controlled and comparable conditions. The legalization of ''Cannabis'' for medical use can pave the way for the gathering of reliable clinical and epidemiological data, which are fundamental for a clear definition of the clinical efficacy and the inherent risks, in a medical environment, of ''Cannabis''. | ||
In this context, Italian legislation has recently relaxed regulations on the administration of medical ''Cannabis'' for a number of medical conditions; it is now possible to use medical ''Cannabis'' in pain therapy, in the treatment of chemotherapy- and radiotherapy-induced nausea and vomiting, and to stimulate appetite in cases of cachexia, anorexia, or cancer and AIDS patients suffering from loss of appetite. It is also being used for other conditions such as glaucoma and Tourette’s syndrome. Moreover, the cultivation of ''Cannabis'' for medical use was recently authorized, and, since 2016, a variety of ''Cannabis'', known as FM2, has been available from the Pharmaceutical Chemical Military Facility in Florence, grown under authorization from the Ministry of Health. This material is available as ground, dried flowering tops containing [[wikipedia:Tetrahydrocannabinol|delta-9-tetrahydrocannabinol]] (THC) in concentrations ranging from 5% to 8% and [[wikipedia:Cannabidiol|cannabidiol]] (CBD) from 7.5% to 12%. These percentages refer to the “total” content, i.e., the sum of the components in acid form ([[wikipedia:Tetrahydrocannabinolic acid|delta-9-tetrahydrocannabinolic acid]] [THCA] and cannabidiolic acid [CBDA]) and decarboxylated form (THC and CBD).<ref name="ItalyDecreto1990">{{cite journal |url=https://www.gazzettaufficiale.it/eli/id/1990/10/31/090G0363/sg |title=Decreto del Presidente della Repubblica 9 ottobre 1990, n. 309 |work=Gazzetta Ufficiale |volume=255 |issue=67 |year=1990}}</ref><ref name="ItalyDecreto2015">{{cite journal |url=https://www.gazzettaufficiale.it/eli/id/2015/11/30/15A08888/sg |title=Decreto 9 novembre 2015 - Funzioni di Organismo statale per la cannabis previsto dagli articoli 23 e 28 della convenzione unica sugli stupefacenti del 1961, come modificata nel 1972 |work=Gazzetta Ufficiale |volume=279 |year=2015}}</ref><ref name="SCFMProduz19">{{cite web |url=https://www.farmaceuticomilitare.it/cannabis.aspx?lnrid=25 |title=Produzione ''Cannabis'' ad uso Medico |work=Progetto pilota ''Cannabis'' |author=Stabilimento Chimico Farmaceutico Militare |date=2019 |accessdate=25 January 2019}}</ref> | |||
Revision as of 19:42, 19 August 2019
| Full article title | Development of standard operating protocols for the optimization of Cannabis-based formulations for medical purposes |
|---|---|
| Journal | Frontiers in Pharmacology |
| Author(s) |
Baratta, Francesca; Simiele, Marco; Pignata, Irene; Enri, Lorenzo R.; Torta, Riccardo; De Luca, Anna; Collino, Massimo; D'Avolio, Antonio; Brusa, Paola |
| Author affiliation(s) | University of Turin, Amedeo di Savoia Hospital, CoQua Lab S.r.l., Città della Salute |
| Primary contact | Email: francesca dot baratta at unito dot it |
| Editors | Kirsch, Wolff M. |
| Year published | 2019 |
| Volume and issue | 10 |
| Page(s) | 701 |
| DOI | 10.3389/fphar.2019.00701 |
| ISSN | 1663-9812 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.frontiersin.org/articles/10.3389/fphar.2019.00701/full |
| Download | https://www.frontiersin.org/articles/10.3389/fphar.2019.00701/pdf (PDF) |
 |
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Abstract
Under current legislation in Italy, using the Cannabisplant for medical purposes requires administering it orally in the form of a decoction or as Cannabis oil extract. The scientific literature reports a number of preparation methods, mainly for oils, but no study is available that compares thoroughly, from a technological viewpoint, the Cannabis-based formulations currently administered to patients. With this in mind, this research work aimed to carry out specific formulation studies to design standard operating procedures for the preparation and optimization of Cannabis-based galenic formulations. Both decoctions and oils were prepared under different operating conditions to identify the most efficient process for the production of formulations with a high concentration of decarboxylated delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Regarding Cannabis oil, a new procedure has been developed that allows significantly higher recovery rates for THC and CBD compared with those for water-based extraction methods (decoction) and those for oil-based methods currently in use. Moreover, based on the results, it is possible to affirm that the prescription of Cannabis-based decoctions should not be the recommended first-choice solution for therapy, considering the low concentration of THC and CBD and, consequently, the high volume of decoction that the patient would have to ingest.
Introduction
In the past, the Cannabis plant was widely used for its curative properties in traditional medicine. In the last century, it became the focus of attention for the abuse of its psychotropic effects. Consequently, the cultivation and sale of Cannabis were outlawed in many countries.[1][2] However, in recent years, cannabinoids have seen a resurgence in consumption, in part, because of media attention and, in part, because of misplaced expectations of efficacy in some pathologies unsupported by scientific literature.[3][4]
To date, studies on the therapeutic efficacy of Cannabis in certain pathologies have yielded results that are, at best, contradictory and, generally, inconclusive given that the studies were carried out on inhomogeneous populations, used differing extraction processes, and administered differing dosages.[5] Moreover, the experiments were performed without proper control procedures and were administered by different routes. These uncertainties stem in part from legislative restrictions that, over time, have severely hindered the performance of rigorous clinical studies under controlled and comparable conditions. The legalization of Cannabis for medical use can pave the way for the gathering of reliable clinical and epidemiological data, which are fundamental for a clear definition of the clinical efficacy and the inherent risks, in a medical environment, of Cannabis.
In this context, Italian legislation has recently relaxed regulations on the administration of medical Cannabis for a number of medical conditions; it is now possible to use medical Cannabis in pain therapy, in the treatment of chemotherapy- and radiotherapy-induced nausea and vomiting, and to stimulate appetite in cases of cachexia, anorexia, or cancer and AIDS patients suffering from loss of appetite. It is also being used for other conditions such as glaucoma and Tourette’s syndrome. Moreover, the cultivation of Cannabis for medical use was recently authorized, and, since 2016, a variety of Cannabis, known as FM2, has been available from the Pharmaceutical Chemical Military Facility in Florence, grown under authorization from the Ministry of Health. This material is available as ground, dried flowering tops containing delta-9-tetrahydrocannabinol (THC) in concentrations ranging from 5% to 8% and cannabidiol (CBD) from 7.5% to 12%. These percentages refer to the “total” content, i.e., the sum of the components in acid form (delta-9-tetrahydrocannabinolic acid [THCA] and cannabidiolic acid [CBDA]) and decarboxylated form (THC and CBD).[6][7][8]
References
- ↑ Lafaye, G; Karila, L.; Blecha, L. et al. (2017). "Cannabis, cannabinoids, and health". Dialogues in Clinical Neuroscience 19 (3): 309–16. PMC PMC5741114. PMID 29302228. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5741114.
- ↑ Pisanti, S.; Bifulco, M. (2019). "Medical Cannabis: A plurimillennial history of an evergreen". Journal of Cellular Physiology 234 (6): 8342–8351. doi:10.1002/jcp.27725. PMID 30417354.
- ↑ Hill, K.P. (2015). "Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems: A Clinical Review". JAMA 313 (24): 2474–83. doi:10.1001/jama.2015.6199. PMID 26103031.
- ↑ Whiting, P.F.; Wolff, R.F.; Deshpande, S. et al. (2015). "Cannabinoids for Medical Use: A Systematic Review and Meta-analysis". JAMA 313 (24): 2456–73. doi:10.1001/jama.2015.6358. PMID 26103030.
- ↑ Bar-Lev, S.L.; Abuhasira, R.; Novack, V. (2018). "Medical cannabis: Aligning use to evidence-based medicine approach". British Journal of Clinical Pharmacology 84 (11): 2458–62. doi:10.1111/bcp.13657. PMC PMC6177696. PMID 29859014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177696.
- ↑ "Decreto del Presidente della Repubblica 9 ottobre 1990, n. 309". Gazzetta Ufficiale 255 (67). 1990. https://www.gazzettaufficiale.it/eli/id/1990/10/31/090G0363/sg.
- ↑ "Decreto 9 novembre 2015 - Funzioni di Organismo statale per la cannabis previsto dagli articoli 23 e 28 della convenzione unica sugli stupefacenti del 1961, come modificata nel 1972". Gazzetta Ufficiale 279. 2015. https://www.gazzettaufficiale.it/eli/id/2015/11/30/15A08888/sg.
- ↑ Stabilimento Chimico Farmaceutico Militare (2019). "Produzione Cannabis ad uso Medico". Progetto pilota Cannabis. https://www.farmaceuticomilitare.it/cannabis.aspx?lnrid=25. Retrieved 25 January 2019.
Notes
This presentation is faithful to the original, with only a few minor changes to presentation. Some grammar and punctuation was cleaned up to improve readability. In some cases important information was missing from the references, and that information was added. The original article listed references alphabetically; this version, by design, lists them in order of appearance.
