SunLand™ Naturals Patent Pending Nanopar Process
Cannabidiol (CBD) is an active ingredient when delivered into human blood. It is typically extracted from hemp plants, and is delivered in many ways including absorption through the human mouth lining or digestive system. When swallowed, CBD suffers from degradation in the stomach and intestines before it is absorbed. Then, upon absorption in the intestines, it passes through the liver before reaching the rest of the body where CBD is further degraded. One study found that, when a given amount of CBD is swallowed versus when injected, the amount measured in the blood though swallowing is only 6% of the amount measured in the blood via injection.
A method for avoiding the degradation of the stomach, intestines, and liver is to absorb the active ingredient through the mucosal mouth lining. However, when this is attempted, large portions are typically swallowed and only a small portion is absorbed through the mouth lining. A method for delivering ingredients in the mouth is from a lozenge. If the lozenge adheres to a surface in the mouth, it is commonly called an oral adhering lozenge or tablet or disc.
An impediment to absorption of CBD delivered in the mouth and/or swallowed is that, in pure or partly pure preparations at room temperature or human body temperature, it is a non-water-soluble solid with strong crystal structure. When placed in the mouth and when swallowed, the active ingredient crystals are then separated into loose molecules and the crystals will not easily pass though the mucous membrane of the mouth and gastro-intestinal (GI) tract. To achieve high levels of absorption, the crystals of the active ingredients need to be broken into nano-particles of a small number of molecules or into loose single molecules to achieve high levels of absorption.
When particles of CBD are placed in a mouth, particles comprising more than one molecule or a few molecules will achieve little penetration through the mouth lining and will instead be swallowed and will then achieve little penetration of the GI tract. The molecules need to be largely separated from each other to achieve substantial penetration through the mucous linings. To separate the molecules of normally solid active ingredients, some active ingredients may be suspended or dissolved in liquid as individual particles and the liquid may delivered into the mouth. Where the solid, non-water soluble active ingredient melts at mouth temperature, 37 degrees Celcius, merely holding in the mouth will achieve the desired separation. Or, for active ingredients that are water soluble, releasing the solid into saliva where it dissolves is effective for separating the molecules or other indivisible particles of the active ingredient. However, for active ingredients that do not melt at mouth temperature, are not water soluble, and cannot be suspended in a liquid in separated form, what is needed is a method to place a solid in the mouth, such as a tablet or lozenge, oral adhering disc or oral adhering melt in the mouth, separate the molecules or other indivisible particles from each other and from any other particle to which they may be adhered.
There is a way to maximize the amount of CBD in a solid form delivery vehicle that is, while being delivered in the mouth, broken into individual nano-particles, such as molecules or small clumps or small crystals of a few molecules.
To implement this method, particles of CBD are bound in a lozenge made of an erodible matrix. As the matrix erodes, the particles are progressively exposed at the eroding surface. Erosive forces at the surface of the lozenge, in part from rubbing against mucosa, tongue, and teeth, will break off particles of CBD. If particles that break off are relatively large, they will likely pass through the GI tract with little absorption. The objective is to ensure that as many as possible particles of CBD that break off are nano size, small enough to absorb through the mouth lining and other parts of the gastro-intestinal tract.
For CBD, bio-absorption is the key to effective delivery. CBD in granular, powder, or crystal form has low bio-absorption. More than three-quarters of swallowed CBD in granular, powder, or crystal form passes through the digestive system with no absorption. To achieve good bio-absorption, so it doesn’t just pass through the digestive system, the CBD must be nanopar processed among other ingredients, such as described herein. This patent pending process is called nanopar process.
In the nanopar process, the CBD is coated in a thin film onto grains that form the structure of the matrix. The coated grains may be pressed into a lozenge or oral adhering disc that has CBD highly dispersed (“nanopar process”) so that no substantial crystals are formed. The CBD is spread onto the grains as thinly as possible, down to single molecule thickness, which is too thin to form strong crystals. In use, when the grains are dissolved by saliva, the nano-dispersed CBD is left as loose nano-size particles, including single molecules.
The Sunland™ CDB disc is bilayer, having an adherent layer and a non-adherent layer, so it can adhere to gums (keratinized mucosa) or teeth or orthodontic braces. The adherent layer is acacia gum. It is made by pressing granular material comprising a mixture of compressible grains coated with CBD by the nanopar process. When adhered to the outside of a molar or gums beside such a molar, a non-adhered side of the disc is in contact with the cheek wall which enhances penetration of released nano-particles into the cheek wall.
The disc will generally release nano-particles over a long dissolution time, such as 1-4 hours, for topical application to nearby tissues. A benefit of delivering nano-particles with an adhering lozenge rather than a non-adhering lozenge is that this allows the lozenge to be used safely in the mouth while sleeping when saliva flow is lowest and the nano-particles will linger longest in the mouth.
The Sunland™ CBD disc is made with at least 70 percent acacia gum (gum arabic) in the adhesive layer. The non-adhesive layer includes acacia gum as a binder, xylitol for sweetness, and mint for additional flavor.
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