Clean Green Biosystems have developed a patented process of producing a full spectrum water soluble nano cannabinoids called CANNABI-NA using a proprietary process and product called TRI-GET.
Based on the market demand and disease, we have developed technology to produce the following cannabinoids based end products related to the route of application a) Oral drugs b) Pulmonary drugs c) Nasal drugs and d) Dermal drugs
Administration of active phytochemical components into the human body requires the use of an appropriate vehicle for bringing an effective pharmacological effect of the active component to be transported to the target site in the body. The desired site varies and it may be the blood stream, organs and cells, and so on. Majority of phytochemicals, such as phyto cannabinoids, are either poorly soluble as all natural cannabinoids are highly lipid soluble.
It is known that the delivery of these phyto cannabinoids is significantly influenced by their physicochemical properties, such as water solubility, partition coefficient, lipophilicity and crystallinity, and so on. A major obstacle in the development of cannabinoid based drug has been the lower water solubility which makes it difficult to develop effective formulation for human use.
Constructing an appropriate vehicle and the desired efficient formulation possess a challenge to the medical cannabis industry. To overcome the instability, poor water solubility, and to enhance the bioavailability of these phyto cannabinoids one option is to entrap these phyto cannabinoids into a matrix of nanoemulsion. Nano emulsion based delivery system have been proved to be one of the best platform to enhance the bio availability and biological effectiveness of different phytochemicals.
Nanoemulsions have been successfully used for many years in the food, cosmetic, pharmaceutical and chemical industries. Nano emulsions has the potential to greatly increases the bioavailability of cannabis based products such as tablets, capsules, creams and sprays.
Nanoemulsions are a class of extremely small droplet emulsions that appear to be transparent or translucent with typical colour. They contain continuous phase, dispersed phase and emulsion stabilizer, the emulsifier or called the surfactant. They are usually in the range 50 to 200 nm.
The nano emulsions are having the following advantages (i) high kinetic or thermodynamic stability, which provides significantly better stability over unstable dispersions. (ii) either hydrophilic or lipophilic phytochemicals can be incorporated into the same nanoemulsions; and (iii) because of the small droplet sizes, phyto cannabinoids can be transported through the cell membranes much more easily, resulting in an increased phyto cannabinoid concentration in plasma and bioavailability.
Cannabis extracts are mostly lipophilic (hydrophobic), and hence to have a proper absorption in the human system, it is to be made into water soluble nanoemulsion with a water dispersion stabilized by an interfacial film of surfactant molecule having droplet size range 20–600 nm.
It is been reported that, the oral bio availability of cannabinoids range from 13-19% and inhalation bioavailability is between 11-45% (mean 31%). So to have higher bio availability, it is better to be formulated into a highly bio available compound using bio availability enhancers.
“The phenomenon of increasing the total availability of any chemical entity (nutrient or drug molecule) in biological fluid or systemic circulation is called biopotentiation or bioenhancement and the secondary agents which are responsible for this augmentation of plasma concentration of principle ingredient are termed as Biopotentiators or Bioavailability enhancers”.
Advantage of bioenhancement Bioavailability is directly proportional to the available plasma concentration so ultimately related therapeutic efficacy. 1. This can make the expensive drugs affordable by lowering the dose or dosing frequency. Shortening the treatment period also increase the acceptance of patients mainly in case of chemotherapy. It comforts the patient in terms of cost also. 2. Reduce the required dose ultimately reduce the toxic effects. 3. Therapeutic treatments which include heavy doses, accompanied by loss of metals and vitamins available in body. The bioenhancers improve the nutritional status of body while duration of course
While developing a drug delivery system for a cannabis based product, the knowledge on the cannabinoids receptor site is important to select the ingredients. Because of their lipophilic character, cannabinoids can penetrate cellular membranes by diffusion. The possible explanations for cannabinoid activity included unspecific membrane binding resulting in fluidity- and permeability changes of neural membranes, the inhibition of acetylcholine-synthesis, an increase in the synthesis of catecholamines, and an interaction with the synaptosomal uptake of serotonin .However, it was established in the mid 1980s that cannabinoid activity is highly stereo selective indicating the existence of a receptor mediated mechanism. The human cannabinoid receptors are of two types. CB1 receptors, which are present mainly in brain and spinal cord. CB2 receptors , present in spleen and immune cells. Both are 7 helix transmembrane receptors coupled to G-Protein.
While selecting the ingredients care must be taken that these inert ingredients should not be toxic to human, should not alter the molecular structure of active ingredients and have to enhance the storage stability. Also, the ingredient must be listed in FDA regulations.
Based on the science, we select the key inert ingredients, which have the following pharmacological activity.
Cannabi-na tm is a water soluble nano cannabinoid , that can be used in the formulation of oral, pulmonary, dermal and nasal routes. It can also be used in the formulation of health drinks, candies and chocolates.
The manufacturing system of Cannabi-na tm comprises of 3 reactors. Each reactor receives proprietary ingredients, which convert the crude cannabinoids or pure fractions of cannabinoids into a water soluble compound. The attached PFD explains the process in detail.
We, Clean Green Biosystems offer the turn key solutions for producing the nano cannabinoids . The equipments conform to ASME standards.