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Use of Microfluidizer Technology for Cannabis Products

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Application Note Use of MicrofluidizerTM Technology for Cannabis Products In the United States, 28 states and Washington DC have legalized medical marijuana. Among those, 8 States plus Washington DC have legalized marijuana for recreational use. In 2016 the revenue was ~ $6.7 billion. An increase of 30% in the next 4 years is forecasted. Up to 50% of the products being legally sold are for oral consumption (commonly referred to as “Edibles”). Oral products have a lot of advantages over smoking. There are >700 strains of Cannabis. Growers constantly come up with new strains. Some of them take off and become recognizable, while others disappear. Growers usually target certain characteristics when they combine 2 strains. There are about 111 cannabinoids. The two main ingredients are Tetrahydrocannabinol (THC) and Cannabidiol (CBD). THC produces the euphoric effect with some therapeutic benefits, while CBD offers a wide range of proven medical benefits such as anti- inflammatory, anti-oxidant, anti-anxiety, etc. However, there is a major challenge when formulating cannabis oil into edible and topical products. Cannabis oil has poor water solubility and low bioavailability. Bioavailability through smoking can vary between 2- 56%. Direct oral administration of raw or un- encapsulated cannabis oil, e.g., eating a cookie, provides even lower bioavailability of only 6-20%. On top of this, the onset of the effect can be delayed as much as 60 minutes, and it takes hours after digestion to reach peak effect. Why MicrofluidizerTM Technology The low bioavailability of cannabis oil can be overcome by formulating the products into nano-emulsions or encapsula- tions. It has been demonstrated that the previously men- tioned bioavailability can be increased to 50-75% through nano-formulations. The time required to respond to a recrea- tional edible is also reduced even at lower dosages. This also increases safety by avoiding the incentive to multi-dose. For CBD based creams and lotions, nano-emulsion formulations typically achieve the same therapeutic effects at much lower dosage as a result of increased bioavailability. Reducing the dose can also reduce the various adverse effects of cannabis consumption. When making a nano-emulsion, droplet size, and polydisper- sity index (PDI), are important considerations. These param- eters can greatly affect the stability of the nano-emulsion. High polydispersity indicates existence of large droplets, which can destabilize the emulsion through phenomena such as Ostwald ripening. Therefore, narrow size distribution is desired as it can mean longer product shelf life. Last but not least, when the droplet size is below 100nm, nano-emulsions become translucent or even transparent in appearance. This can be particularly beneficial in clear bev- erage applications. Microfluidizer technology is the only technology that can cre- ate nano-sized emulsions or encapsulations meeting all of the above requirements. Unlike all other types of technolo- gies, whether they be mixers or homogenizers, Microfluidizer processors provide the highest uniform shear rates on the market by utilizing fixed geometry interaction chambers and extremely high constant processing pressures. Microfluidizer technology also guarantees scale-up so that product pro- cessing and results are consistent from development to manufacturing. In addition, Microfluidizer processors have a proven track record of meeting all FDA requirements for food and pharmaceutical production. Microfluidics Application Note Cannabis 0.1 1

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