Medicinal cannabis refers to cannabis and its component cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD), which are used in medications designed to either treat diseases and/or alleviate symptoms of these diseases. There are more than 70 psychoactive compounds called “cannabinoids”.
The endocannabinoid system (ECS) is a biological system composed of endocannabinoids, which are endogenous lipid-based retrograde neurotransmitters that bind to cannabinoid receptors, and cannabinoid receptor proteins that are expressed throughout the vertebrate central nervous system (including the brain) and peripheral nervous system. The endocannabinoid system is involved in regulating a variety of physiological and cognitive processes including fertility, pregnancy, during pre- and postnatal development, appetite, pain-sensation, mood, and memory, and in mediating the pharmacological effects of cannabis. (source: Wikipedia)
Research done in the field by various international medical bodies has concluded that cannabinoids acts on 2 types of cannabinoid receptors: CB1 and CB2. CB1 receptors are mainly found in the brain, peripheral nerves, and nervous system, whereas CB2 are found both in the neurons and immune
cells.
Cannabis-based products are widely used by patients suffering from various diseases such as Epilepsy, Multiple Sclerosis, Spinal Cord Injury, Spinal Cord Disease, Cancer, AIDS, Insomnia and many more.
From research done in the field it was concluded that the THC acts on 2 types of cannabinoid receptors: CB1 and CB2. CB1 receptors are mainly found in the brain, peripheral nerves, and nervous system, whereas CB2 are found both in the neurons and immune cells.
Evidence suggests that THC helps alleviate symptoms suffered both by AIDS patients and by cancer patients undergoing chemotherapy, by increasing appetite and decreasing nausea.
The other main ingredient is CBD, a non-psychoactive component of cannabis which accounts for more than 50% of the known therapeutic applications. CBD is considered to have a wider scope of medical applications. A range of clinical studies indicated that CBD appears to relieve convulsion, inflammation, anxiety, nausea and short term memory loss.
Cannabinoids are the reason that medical cannabis research is one of the fastest moving frontiers in pharmacology
Currently, the two main cannabinoids that are of medical interest are THC and CBD
There are several FDA-approved medications with synthetic cannabinoids as APIs, Dronabinol and Nabilone: Marinol, Cesamet, Syndros. Paradoxically, FDA has not recognized or approved cannabis as medicine.
Trends are moving towards naturally derived phytocannabinoids. Medicines of natural origin are: Sativex, Epidiolex
Unique effects of different cannabis preparations are attributed to synergism of their constituents: cannabinoids, terpenes, flavonoids and others
More and more countries are regulating use of cannabis for medical purposes
Continued research will lead to new medications as well as new indications.
Active substance is the compound or their mixture with the role of API in natural pharmaceutical products.
API Active Pharmaceutical Ingredient is a single substance used in a finished pharmaceutical product, intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
Cannabinoids are terpenophenolic compounds, active substances that interact with cannabinoid receptors of the human body, causing pharmacological effects.
Dosage form – A term for the physical characteristics of a drug product in the finished form that is suitable to be used at once, without additional measuring by the user. e.g., patch, sublingual, capsule.
Extraction is a process of extracting the desired active substance from the herbal drug. It results in separated fractions: a complex extract with cannabinoids and terpenes; and a matrix – ballast material such as cellulose, chlorophylls, waxes etc.
GACP – Good Agricultural and Collection Practice are guidelines prescribing cultivation and collection of medicinal plants, including certain post-harvest operations. They are primarily intended to provide general technical guidance on obtaining medicinal plant materials of good quality for the sustainable production of herbal products classified as medicines.
GMP – good manufacturing Processes, also known as Current good manufacturing Processes (CGMP) provide guidelines for manufacturing, testing, and quality assurance to ensure that a product is safe for human or animal consumption or use.
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. (FDA) HACCP has been also applied to industries other than food, such as cosmetics and pharmaceuticals.
Herbal medicinal products are made of herbal drugs and contain herbal substances as active ingredients.
Magistral preparation is a pharmaceutical product, prepared in pharmacy. It makes medications available in formulations that do not exist commercially. It is a practical way for your doctor to personalize your treatment according to your needs. Natural vs synthetic In theory, cannabinoid molecule of a synthetic origin should be exactly the same as its phytocannabinoid analogue that is produced with biosynthesis in the cannabis plant. However, a phenomenon of natural active substance is synergism, a beneficial feature of cannabis compounds that is known to exist but currently not known enough to be replicated by a man in its whole manifestation.
Phytocannabinoids are cannabinoids that occur naturally in the cannabis plant. They are abundant in the viscous resin that is produced by glandular structures called trichomes. The most abundant phytocannabinoids are tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC) and cannabinol (CBN). In the plant itself, they exist in the form of carboxyl acids. In the body, carboxyl acids have different pharmacological effects than their decarboxylated forms, so most cannabis preparations, intended for medical or recreational use are being decarboxylated prior use.
Purification is a procedure of different chemical methods that result in physical separation of a cannabinoid of interest from foreign or contaminating substances, all up to 99,9 % purity.
Separation/isolation is a method to achieve any phenomenon that converts a mixture of chemical substance into two or more distinct product mixtures. We use separation and isolation techniques to produce different raw materials with desired content of cannabinoids and terpenes for pharmaceutical use.
SOP – Standard Operating Procedures are written instructions intended to document how to perform a routine activity. Many companies rely on standard operating procedures to help ensure consistency and quality in their products. Standard operating procedures are also useful tools to communicate important corporate policies, government regulations, and best practices.
Synergism is such an interaction of APIs from herbal drugs that the total pharmacological effect is greater than the sum of the individual effects of any of them. Synergism occurs when different cannabinoids, terpenes, flavonoids and others are working together and enhance the effect to an extent that cannot be produced by a single cannabinoid.