Development of cannabis-based pharmaceutical products – Purchase Medical THC Store Mississauga Canada

Herb Approach

The galenic activity of the pharmacist is necessary to transform any plant in dosage and form of medication, respecting the standards of good preparation, to guarantee quality, efficacy and safety finishes, tailored to the patient.

In Italy, on November 9, 2015, the government initiated a project for the galenic-master preparations of plant origin based on cannabis[1], leaving the whole process in the hands of the pharmaceutical companies, and together with the approval of a decree law that regulates the national production of cannabis and the products derived from this plant.

Access medical cannabis in pharmacies

The pharmacist, with medical prescription of the patient, you must make a request to the military pharmaceutical establishment (Stabilimento Farmaceutico Militare) or to other entities that the Ministry has[2]. Only after having followed each necessary bureaucratic formalism, the pharmacist can perform master preparations, keeping the Good manufacturing practices (BPM)[3], and may dispense cannabis for oral or inhaled use, as prescribed by the doctor.

To this day, the supply of cannabis in pharmacies is subject to the shipment of specific Cannabis Sativa L varieties:

  • FM2: 5-8% THC and CBD between 7.5% and 12% (Sativa variety)
  • BEDROCAN: 19% – 21% THC and CBD <1% (Sativa variety)
  • BEDIOL:5% THC and CBD 8% (Sativa variety)
  • BEDROLITE: THC <1% and CBD 9% (Sativa variety)
  • BEDICA: THC 14% and CBD <1% (Indica variety)

Pharmaceutical preparation of cannabis-based medicines

Once the pharmacist has received the inflorescence, he is in charge of manufacturing the products. The elaboration will depend on the variety used and the form of product that the doctor has prescribed. Thus, the pharmacist can develop different forms of cannabis-based medicines, depending on the different routes of administration: oral or inhaled[4].

Valuation of cannabis-based pharmaceutical products

In order to ensure the quality of the product, the Ministry requires that "the numbering of the active principles must be carried out for each master prescription, with sensitive and specific methodologies, such as liquid or gas chromatography together with the mass spectrometry. In addition, the extraction method used must comply with current regulations. "

Extraction of cannabinoids

To work with inflorescences, pharmacists have to work with extractions in oil and / or in other alcohol solvents.

The SIFAP[5] РItalian Society Pharmaceutical Preparers (Società Italiana Farmacisti Preparatori)[6] Рcreated a technical group in 2016 to develop shared procedures of the oil-based extraction, with the aim of standardizing the procedure and reproducing its results throughout the national territory (Italian and European).

The group began to work on two studies, in collaboration with the University of Milan and with the Università degli Studi di Napoli, Federico II, with the objective of selecting a extractive methodology to achieve the highest extraction of THC and other cannabinoids, but at the same time, safeguarding the entire composition of the phytocomplex.

Independently of the extractive method, the group has marked the need to put extraction before a heating phase, a procedure known as decarboxylation. The importance of heating the preparation derives from the problem that all phytocannabinoids are present in the plant in their shapes acidic. However, not all phytocannabinoids interact with CB1 and CB2 receivers, but those that link with these receptors do so in their neutral forms, not carboxylated, not acidic.

Accepted methodology: cannabis maceration in oil

The only method, recognized by the SIFAP group, imposes the maceration of cannabis flowers in vegetable oils, such as olive oil or sunflower, for example.

At the end of the procedure, keeping the volume of the solution intact, the initial concentration of cannabinoids in the flower will be reduced to a tenth of the solution, leaving a minimum concentration in the final product.

In such a way, as affirmed by the SIFAP group, the objective of maintaining the highest possible THC content has not been fulfilled.

Alternative methodology: extraction in alcohol

If we analyze the extraction processes, we will see that phytocomplex concentrations are variable depending on the solvent, for its physical characteristics. In this sense, we consider replacing olive oil with an alcoholic solvent, the ethanol, which today is considered one of the best and least toxic alcohol solvents.

Just as during the maceration in olive oil, macerating the cannabis flowers in ethanol, all the phytocannabinoids are separated from the vegetable mass and dissolved in the solvent. However, as soon as the alcohol solution comes in contact with the air, a evaporation process, which will never happen if oils are used as solvents. At the end of the process, the substance that will remain is the pure extract, which contains the entire phytocomplex. Furthermore, if we indirectly heat the solvent, it will also be subjected to the decarboxylation process, which will accelerate the evaporation of excess solvent and transform most of the cannabinoids into their own neutral forms. In this way, the extraction reduces its volume, with the following increase in the concentration of each cannabinoid present.

This extraction will have the entire phytocomplex and can be correctly evaluated in all its purity, to know its exact composition of cannabinoids.

Results of cannabis extraction in alcohol

Knowing exactly how much extraction can be obtained with this method depends on the variety of plant and the type of solvent used. However, only once the resin has been obtained will it be possible calculate the exact composition of cannabinoids present. We will give a concrete example and to facilitate the understanding we will round the calculations.

We imagine that we want to obtain 100 gr of extract. If we start with a cannabis strain with a 10% THC content, once the solvent is evaporated and the plant mass is removed, the final extract will present a considerable increase in its concentration. In order to know up to what volume the concentration has risen, it is necessary to proceed with the analysis of the product, through a liquid or gas chromatography.

Under the hypothesis that the extract, reached at this point of processing, has a THC concentration of 30%. This implies that of 100 g of extract obtained, 30 g is exactly the amount of THC throughout the extraction. In this way, knowing that a 10% THC oil has 1 g of THC in 10 ml of solvent, diluting 3.3 g of complete extraction in 10 ml of oil, you will obtain exactly the amount of THC desired and that the doctor has prescribed in the recipe.

In addition, we will have enough extract to produce other drugs, specific to each patient, and that will be controlled and, consequently, uniformly standardized.

conclusion

Although the calculations we have just used are purely explanatory, not necessarily correct, the objective of this article is to make clear how this alternative procedure can offer a much more controllable and standardized product, which would leave the pharmacist the possibility of develop different products, specific for each patient, but uniformly controlled.

In addition to all this, the Ministry would have the possibility of having all the necessary information on these treatments and their effectiveness in different diseases and people, and on the exact composition of each product offered by the pharmacy.

It is vitally important that Pharmacists are aware of all the possible elaborations of Cannabis, Of how control the final results and, in this way, from standardize the procedure and control, chemical and bureaucratic.

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Did you like this post? Make an assessment. This post has been made based on existing research until the date of publication of the article. Due to the increase of studies around medical cannabis, the information exposed may vary over time and we will inform in subsequent writings.

[1] Ministerial Decree, 9 November 2015, Gazzetta Ufficiale della Repubblica Italiana

[2] "Riferimenti normativi sulla coltivazione della cannabis in Italia" (30 maggio 2018), Camera dei deputati.

[3] "Guide for GMP Documentation and Records"

[4] Corso Superiore SIFO in clinical pharmacy – Prof. Puglisi Giovanni (Ottobre 2017) "Cannabis for therapeutic use: dispensation in pharmacy"

[5] Società Italiana Farmacisti Preparatori (Settembre 2016) "SIFAP proposes a method per l'Estrazione oleosa di infiorescenze femminili di Cannabis

Summary

Development of cannabis-based pharmaceutical products: from the plant to the drug

Article

Development of cannabis-based pharmaceutical products: from the plant to the drug

Description

Currently, countries like Italy have reserved the production of cannabis-based products only to pharmacies, following established production standards.

Author

Mario Romano

Publisher Name

Kalapa Clinic

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