Journal:Development of standard operating protocols for the optimization of Cannabis-based formulations for medical purposes

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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)

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.


References

  1. 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. 
  2. 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. 
  3. 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. 
  4. 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. 
  5. 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. 

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.