Medicinal Pharmaceutical Formulation Lab
Background
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The 2018 Farm Bill legalized CBD to be grown in the U.S. On June 25, 2018, the FDA approved the first CBD based medication, called Epidiolex. This medication is the preferred prescription Medication used to treat a rare type of epileptic seizure in pediatric patients. Another CBD based medication, Sativex, has been approved and is being prescribed in 29 countries, in and out of Europe, to treat Multiple Sclerosis. Sativex is expected to be approved by the FDA for use in the U.S., as well.
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Once Epidiolex was FDA approved, the FDA took the position that all CBD products fall under the umbrella of being pharmaceutical. However, the FDA has not yet put out regulation guidelines which has created more confusion than clarification. Currently, only 17% of all CBD sales in the U.S. are pharmaceutical grade…and, one product, Epidiolex, represents 94% of these entire sales.
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WHS Medicinal Pharmaceutical Lab will be a pioneer in formulating CBD medicinal pharmaceutical products for treating a variety of diseases, conditions and syndromes. It is important to have a brief understanding as to why CBD, and other cannabinoids, happen to be so critically important to human and animal health.
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The only CBD based medications which regulatory agencies approve will need to be pharmaceutical, and WHS will be one of only a few CBD based Medicinal Pharmaceutical Labs in the entire world which can fulfill this obligation. The WHS will be very scientifically aggressive in identifying a roadmap to use to formulate the new discoveries in CBD based Medicinal Pharmaceutical Medications which will matter most for human use.
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As these new formulas work their way through the phases of Clinical Trials and then become approved for use, they will then offer the advantage of their benefits to patients. In doing so, the WHS scientists will begin filling the void that exists with current ineffective synthetic medications.
Endocannabinoid System
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Our scientists are well versed in the endocannabinoid system. To appreciate the importance and value of the cannabinoid pharmaceutical product market, it is essential to have a basic understanding of cannabinoids and how they function in humans and in animals.
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In the late 1980’s scientists first discovered and began to study a complex part of the human body called the endocannabinoid system (ECS). According to Peter Greenspoon, the author of “The Endocannabinoid System; Essential and Mysterious”, published in Harvard Health, Aug. 11, 2021, the ECS, via CB1 receptors “regulates and controls many of our most critical bodily functions” some of these include: “learning and memory, emotional processing, sleep, temperature control, inflammatory and immune responses, and eating”. The ECS, via CB2 receptors, “modulate intestinal inflammation, contraction, and pain in inflammatory bowel conditions.” “The ECS is currently at the center of international research and drug development.”
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Our bodies produce molecules called endocannabinoids which have a structural similarity to the molecules found in the cannabis plant. These cannabinoids attach to CB1 and CB2 receptors in the human Central Nervous System (CNS) and the human Peripheral Nervous System (PNS). When a person’s body produces too little of any of these important cannabinoids there is a loss of homeostasis in the body and a person’s health begins to deteriorate. It is in these instances that precision designed medicinal pharmaceutical cannabinoid prescriptions can fill the need of the missing cannabinoid the body isn’t producing at all or isn’t producing sufficiently enough.
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The research in the human and animal Endocannabinoid System is young, is very robust, and is advancing. The 2018 Farm Bill finally opened the door for significant cannabinoid production. Therefore, the need for medicinal pharmaceutical cannabinoid and personal care pharmaceutical cannabinoid products places Wisconsin Hemp Sciences, LLC in a very advantageous position.