Realm of Caring Appoints Research Director to Oversee Groundbreaking Cannabis Data Registry and Medical Studies

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Under the Leadership of Nicolas Schlienz, Ph.D., and its Scientific Advisory Board, the Organization Publishes New Real-World Study on Epilepsy and CBD

 

COLORADO: –Realm of Caring, a nonprofit dedicated to cannabinoid research, has appointed Nicolas Schlienz, Ph.D., as its Research Director, a new role in the organization’s leadership. His first initiative is co-authoring an original study on epilepsy using survey data gathered from RoC’s innovative Observational Research Registry.

Schlienz, a clinical psychologist, led the development of the ORR as a postdoctoral research fellow at Johns Hopkins University. The ORR is a web-based research platform open to adults and adult caregivers of dependents who are, or are considering, the use of cannabis or hemp products for therapeutic purposes. The aim is to better understand the impact that therapeutic use of such products has on individual health, functioning and quality of life.

“There are numerous obstacles to exploring the therapeutic potential of cannabis due to its classification as a Schedule I controlled substance,” Schlienz said. “Research opportunities such as the ORR expand the existing scientific knowledge base to better inform clinical decision making, and also dispels the stigma surrounding medicinal cannabis use.”

Schlienz and colleagues have published a paper summarizing ORR data from individuals with epilepsy in the medical journal Epilepsy & Behavior. The longitudinal study showed that individuals who used artisanal cannabidiol (CBD) products reported better quality of life, lower psychiatric symptom severity and fewer medication-related adverse events compared with those not using CBD.

“This study represents a refreshing collaboration of scientists, clinicians, patients and advocates. The results affirm what has been suspected for a long time, that cannabinoid products have value in the treatment of epilepsy as well as associated neuropsychiatric conditions,” said Jay Salpekar, MD, an Associate Professor of Psychiatry and Neurology at Johns Hopkins University. “It is our hope that this study may embolden clinicians and patients to effectively partner in considering these treatments.”

Based on these findings, he and study co-author Ryan Vandrey, Ph.D., plan to conduct a controlled clinical trial to further understand the effects of CBD in epilepsy treatment.

Real Talk About Hemp Regulation

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Rules and regulations in hemp and CBD are not four-letter words.

By Jason Waggoner, Senior Vice President, General Manager, EcoGen Biosciences

The Farm Bill legalizing hemp was passed and signed into law in December of 2018. Yet, as of today, nearly two years later, the industry still hasn’t received concrete direction or guidance from the FDA. But, with the introduction of the Hemp Access and Consumer Safety Act, we could see that change.

Introduced by U.S. Senator Ron Wyden in May of 2021, the bill has support from the Consumer Brands Association, the Wine and Spirits Wholesalers of America, Hemp Roundtable, and more. Senator Wyden said in a statement, “CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone. It’s been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”

At EcoGen, we have been closely following the introduction of the Hemp Access and Consumer Safety Act to Congress, and we applaud lawmakers for continuing to strive for federal legislation that allows safe and open access to high-quality hemp-derived products. Without going into significant detail, the bill intends to provide the pathway for the use of CBD in dietary supplements, so long as those supplements adhere to all other regulations associated with the product.

We believe this is simply the next step in the evolution of the hemp industry, and specifically, the CBD market. This bill signifies the next iteration of regulation necessary for bringing CBD to the consumer.

FDA guidance is the last link in the chain of commerce

Governance and regulation are often mentioned with a negative connotation. Many producers fear government oversight, but it’s a common misconception that federal guidance will ultimately lead to the death of the small business. In fact, the opposite could be true.

Mom-and-pop operators are going out of business right now, and even some larger enterprises are struggling. The source of the problem isn’t regulation; it’s actually due to a lack of regulation.

Without regulation and FDA guidance, we can’t sell our products. The lack of regulation prevents retailers from entering the space, and without retailers, products can’t be sold. So, many of the producers, who were banking on regulation and a proper market, went bankrupt.

Large or small, many organizations are doing things the right way. For those producers, when regulation comes, they’ll be able to pivot quickly and adjust to the market. Those who have prepared for it will be more victorious than others.

Being rewarded for a job well done

With many of us having CPG backgrounds, the depth of experience at EcoGen runs deep. We understand that there are consumer safety concerns in hemp and CBD production. Today, consumers simply don’t know where the material in their products comes from. Unfortunately, there are just as many players manufacturing products with a total disregard for safety as there are producers who put consumer safety first.

Regulations help improve product quality through safe employment initiatives, benefit programs for employees, and OSHA standards. Demonstrating the discipline to execute policies for a good working environment, safety and quality assurance programs, proper recall procedures, and supply chains ultimately benefits the consumer. I say with confidence that having the discipline to adhere to regulations will produce a better end product.

Companies like EcoGen aren’t rewarded for going above and beyond in the current market without the necessary regulation. Setting the standards for regulations means carrying costs that many others aren’t incurring. Competing against less scrupulous companies puts reputable producers at a disadvantage. Regulation will level the playing field and reward the companies that are ahead of the curve.

The CBD crash started long before COVID-19

Although 2020 impacted retails sales for almost every industry, the pandemic was not the sole cause of the CBD market crash. Instead, retail sales and online sales declined when the repeat cycle began, and buyers didn’t repeat – which has everything to do with the quality and efficacy of the product.

If the products aren’t efficacious or don’t deliver on the consumer’s expectations, they’ll most likely not repurchase them. Whatever the benefit might be, many consumers are seeking a result from CBD. But without regulation, we can’t educate for that. As it stands, it’s impossible to educate consumers or inform them how to be effective with CBD.

The lack of regulation is breeding a ‘smoke and mirrors’ industry as a result of not having clarity from the governing bodies. Frankly, they’ve created a burgeoning industry full of confusion.

The research is there

Historically, the argument has always been, “We need more research.” Today, that delineation can’t be drawn. All across the globe, research on hemp and how it impacts the human endocannabinoid system has been steadily on the rise. Whether or not it’s the research the FDA would like to see is debatable, but without question, there’s plenty of data available.

The hemp industry and farmers deserve more clarity and guidelines as we work to develop one of the fastest-growing markets in the world — and it’s exciting to watch us move closer to accomplishing that goal. There has been some confusion in the market due to a lack of regulation, but the future looks bright. EcoGen is excited to remain an industry leader and set the bar for compliance, quality testing, and product innovation as new federal legislation develops.

Curt’s Cannabis Corner: Does Cannabis Affect Memory?

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Welcome to the latest installment of Curt’s Cannabis Corner — a series of educational articles from technical writer Curt Robbins at Higher Learning LV and MJNews Network. This collection is intended for cannabis and hemp industry professionals who wish to gain a better understanding of the nuanced biochemistry of this special—and newly legal—herb. 

This week readers learn about the scientific research regarding the controversial topic of the effect of cannabis consumption on brain function and, more specifically, memory and related mental performance.

My thanks to David Rheins, executive director of the Marijuana Business Association in Seattle, for suggesting the topic for this week’s article.  

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Does Cannabis Affect Memory?

By Curt Robbins

Cannabis consumers and patients for decades have faced an intimidatingly confusing mix of sometimes contradictory information regarding the true effects of cannabis on the brain and, specifically, memory and cognition. Since the early 20th century, prohibitionists have been claiming that cannabis use by humans produces a variety of mental problems and deficiencies, from killing brain cells to a range of psychiatric disorders to the lowering of intelligence. 

Programs like D.A.R.E (launched in 1983 in, ironically, Los Angeles) preached the dangers of marijuana use to school children throughout the United States. The natural herb was included with hard drugs known to involve serious physical addiction and sometimes fatal withdrawal symptoms, including heroin and cocaine. Such efforts have served to taint the reputation of cannabis and convince millions of consumers that prolonged use of the plant may result in problems such as memory deficiencies or other cognitive problems. 

Meanwhile, scientists for decades have touted the potential of phytomolecules such as delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD) to do things such as improve the neuroplasticity and overall health of brain cells. This is of understandably significant consequence to the large patient populations afflicted with conditions such as Alzheimer’s, Parkinson’s, and autism. 

Research Study Results 

With such conflicting evidence promoted to several generations of North Americans, what does the hard science and research say? Below are six peer-reviewed research studies conducted over the course of the past two decades regarding the topic of the effect of long-term cannabis use on memory function and overall cognitive performance. 

A 2001 study entitled “Neuropsychological Performance in Long-term Cannabis Users” that was published in the journal Archives of General Psychiatry investigated the longitudinal impact of cannabis use on cognition. 

The human clinical trial study involved 180 test subjects categorized as 63 “current heavy users” (who had consumed at least 5000 times during their lives and were daily users at the time of the study), 45 “former heavy users” (who had consumed at least 5000 times during their lives but fewer than a dozen times in the past three months), and 72 control subjects who had consumed fewer than 50 times during their lives.

All participants abstained from cannabis consumption for 28 days (confirmed by urinalysis), a period over which cognitive and memory performance data was gathered (at day 0, 1, 7, and 28). Reported the study’s authors, “We administered a neuropsychological test battery to assess general intellectual function, abstraction ability, sustained attention, verbal fluency, and ability to learn and recall new verbal and visuospatial information.”
The current heavy users group “scored significantly below control subjects on recall of word lists” during the performance tests administered on days 0, 1, and 7. The researchers found this deficit to be directly and proportionally associated with the level of THC in the blood of test subjects when the study was launched.  

“By day 28, however, there were virtually no significant differences among the groups on any of the test results,” reported the pioneering study. The researchers concluded that their data could detect “no significant associations between cumulative lifetime cannabis use and test scores.”

A 2005 study entitled “Neurocognitive Consequences of Marihuana—a Comparison with Pre-drug Performance” that was published in the journal Neurotoxicology and Teratology explored the “effects of current and past regular use of marihuana [sic].” 

The study involved examination of 113 young adults “evaluated using neurocognitive tests for which commensurate measures were obtained prior to the initiation of marihuana smoking.” The researchers assessed “overall IQ, memory, processing speed, vocabulary, attention, and abstract reasoning.” Like other studies, data gathered indicated that “heavy [cannabis] users did significantly worse than non-users in overall IQ, processing speed, and immediate and delayed memory.” 

However, like the 2001 study cited above, “the former marihuana smokers did not show any cognitive impairments.” The study’s authors concluded that cognitive deficiencies “are evident beyond the acute intoxication period in current heavy users…but similar deficits are no longer apparent three months after cessation of regular use.” The scientists noted that this was true “even among former heavy using young adults.”

A 2006 human trial study entitled “Long-term Effects of Frequent Cannabis Use on Working Memory and Attention” that was published in the journal Psychopharmacology investigated “brain function in frequent but relatively moderate cannabis users in the domains of working memory and selective attention.”

The study involved a relatively small group of only ten human participants who “performed equally well during the working memory task and the selective attention task.” The researchers reported that cannabis users “did not differ from controls in terms of overall patterns of brain activity in the regions involved in these cognitive functions.” However, the report did note that “in comparison to the controls, cannabis users displayed a significant alteration in brain activity in the left superior parietal cortex.”

Despite its low number of test subjects, this research echoes others that indicate little or no difference between consumers and non-consumers of cannabis in terms of memory and cognitive performance—especially after a sustained period of cessation (typically seven to 90 days).   

A 2014 study entitled “Effect of Baseline Cannabis Use and Working-Memory Function on Changes in Cannabis Use in Heavy Users” that was published in the journal Human Brain Mapping intended to “assess the predictive power of working-memory function for future cannabis use and cannabis-related problem severity in heavy users.”

The human trial study involved 73 participants aged 18-25, including 32 “heavy cannabis users” (defined as using more than 10 days per month) and 41 “non-using control” participants who had consumed fewer than 50 cannabis joints during their life and had not used during the year immediately prior to study participation. 

The researchers reported that “behavioral performance and working-memory function did not significantly differ between heavy cannabis users and control [participants].” 

A 2018 study entitled “One Month of Cannabis Abstinence in Adolescents and Young Adults is Associated with Improved Memory” that was published in The Journal of Clinical Psychiatry explored “associations between adolescent cannabis use and poor neurocognitive functioning.” The study involved 88 test subjects aged 16-25 “who used cannabis regularly.” 

The researchers concluded that their data “suggests that cannabis abstinence is associated with improvements in verbal learning that appear to occur largely in the first week following last use.” These results supported the observations of the 2001 study cited above that found cognitive deficiencies in heavy users only during the first week of abstinence, but no such difference from the control group after 28 days.

A 2018 study entitled “Biphasic Effects of THC in Memory and Cognition” that was published in the European Journal of Clinical Investigation reported that cannabis consumption results in “a reversible disruption of short-term memory induced by delta-9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis.” 

The researchers found this “reversible disruption of short-term memory” to most affect “attention, working memory, verbal learning, and memory functions.” The study reported a biphasic response from THC, which produced different results depending on dosage and other usage characteristics. “THC is also able to improve neurological function in old animals when chronically administered at low dose. Compelling data have shown that memory is also affected in a biphasic fashion.”

The study concluded that “THC modulates memory and cognition in a biphasic and age-dependent manner.”

WSLCB Issues Policy Statement On Tetrahydrocannabinol (THC) Compounds Other Than Delta-9

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WASHINGTON: Consistent with RCW 34.05.230, the Washington State Liquor and Cannabis Board (WSLCB) has published a policy statement concerning tetrahydrocannabinol (THC) compounds other than delta-9 and the conversion of CBD, hemp, or both to delta- 8 THC, delta-9 THC, or any other cannabis compound that is not currently identified or defined in the Revised Code of Washington (RCW), the Washington Administrative Code (WAC), or both. 

Policy statements are agency-level documents declaring plans or intentions of an agency. Policies are different from procedures, standard operating procedures, or guidance because they apply to the entire organization and are primarily intended to set direction. In contrast, procedures or guidelines typically include specific instructions used to accomplish defined tasks that may be described in a policy.

Notice of WLSCB Policy Statement #PS21-01 was filed with the Washington State Code Reviser on April 28, 2021 as WSR 21-10-045. The policy statement is offered in response to multiple stakeholder requests and national concern for clarification regarding the regulation of tetrahydrocannabinols (THC), other than delta-9; and the conversion of CBD, hemp, or both to delta- 8 THC, delta-9 THC, or any other cannabis compound that is not currently identified or defined in the Revised Code of Washington (RCW), the Washington Administrative Code (WAC), or both.

Additional information can be found on the WSLCB Policy Statements webpage.

FDA Warns Companies Illegally Selling Over-the-Counter CBD Products For Pain Relief

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Products Listing CBD as Inactive Ingredient Cited for Unapproved Drug and Misbranding Violations

DISTRICT OF COLUMBIA: The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

The FDA issued warning letters to:

The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.

The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Curt’s Cannabis Corner: What is Nanoemulsion Technology? Part 2

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Welcome to the third installment in the series of educational articles from technical writer Curt Robbins at Higher Learning LV and MJBA’s MJNews Network. This collection is intended for cannabis and hemp industry professionals who wish to gain a better understanding of the nuanced biochemistry of this special—and newly legal—herb. 

For the past two weeks, Curt has been teaching readers about the hot new manufacturing process for cannabis- and hemp-infused products called nanoemulsion. 

What is nanoemulsion? How can it help patients and consumers while offering additional marketing opportunities for entrepreneurs? How does it compare to traditional formulation technologies? Read on to learn!

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CANNABIS

CORNER 

What is Nanoemulsion Technology?

Part 2

By Curt Robbins

 

 

Read What is Nanoemulsion Technology?: Part 1. In Part 1, readers learn the definition of nanoemulsion and how it is being employed in the cannabis and hemp industries for the creation of consumer products that feature enhanced bioavailability (including greater potency and faster onset). This formulation tech also allows more accurate dosing, a large advantage to millions of patients and their caretakers. 

In Part 2, let’s dive deeper into this excerpt from the Higher Learning LV course Cannabis Core Concepts by further exploring bioavailability issues, examining some real world metrics, and learning the latest scientific research about nanoemulsion technology! 

End Game: Increased Bioavailability

The purpose of packaging a medicine, wellness tonic, or lifestyle beverage in the form of a nanoemulsion is straightforward: To improve bioavailability. This includes not only greater potency, but also faster onset. 

Onset is an important issue for consumers who require quick relief from conditions such as chronic pain, nausea, seizure activity, and social anxiety, to name only a few. Most within this population cannot tolerate the approximately two-hour wait that characterizes the onset of standard infused edible products (especially given that peak potency requires an additional one to three hours). 

The exact onset period of a particular nanoemulsion depends on several factors, including consumption avenue and the biophysical circumstances under which it is consumed by users. This includes their age, relative health, genetic makeup, medical history, and use of commingling drugs.  

Edible cannabis products formulated with nanoemulsions typically involve an onset period of roughly 10-30 minutes, with 15-20 minutes being a common claim among companies offering infused beverages and edibles featuring nanoencapsulated cannabinoids and terpenes.   

A 2014 study entitled “Enhancement of the Oral Bioavailability of Breviscapine by Nanoemulsion Drug Delivery System” that was published in the journal Drug Development and Industrial Pharmacy explored the ability of a “nanoscale drug delivery system to realize the improvement of its oral bioavailability.” 

Reported the study, “the relative bioavailability of [the nanoencapsulated drug] reached 250 percent.” The researchers concluded that the nanoemulsion enhanced the oral absorption of [the drug] due to “improved stability and permeation.”  

A 2017 study entitled “Nanoemulsion-based Delivery System for Enhanced Oral Bioavailability” that was published in the journal Drug Delivery investigated the relative bioavailability of various formulation approaches, including nanoemulsion. “Nanoemulsion of BBH showed a relative bioavailability of 440 percent compared with unencapsulated BBH.” The study’s authors also reported that the nanoencapsulated liquid remained stable following a six-month evaluation period.  

If performed properly and depending on the exact compounds involved, nanotechnology can result in faster onset and greater potency at lower—and significantly more accurate—doses. This approach offers not only more efficient treatment of conditions such as pain and seizures, but also the economy resulting from smaller volumes of a particular compound or drug that yield greater potency.

Detailed Definitions

Research has revealed that bioavailability of cannabinoids such as CBD and CBG may be increased from as low as six percent in traditional, non-nanoemusified preparations (revealed by this study) to as great as 90 percent with nanoemulsified products (demonstrated by another study). 

According to a 2010 study entitled “Nanoemulsion: A Pharmaceutical Review,” nanoemulsion-based products are “by far the most advanced nanoparticle systems for the systemic delivery of biologically active agents for controlled drug delivery and targeting.” The study noted that nanoemulsion droplet sizes within a particular sample, when accomplished successfully, feature “narrow size distributions” (variance).  

“Nanoemulsions are the thermodynamically stable isotropic system in which two immiscible liquids (water and oil) are mixed to form a single phase by means of an appropriate surfactant [or emulsifying agent] or its mix with a droplet diameter in the range of 0.5-100 nm,” reported the study’s authors. The research concluded that “nanoemulsion shows great promise for the future of cosmetics, diagnostics, drug therapies, and biotechnologies.”

According to a 2014 study published in the journal 3 Biotech, a nanoemulsion is a “fine oil/water or water/oil dispersion” featuring a droplet size range of 20–600 nm. The study explained that three primary types of nanoemulsions exist: “(a) oil in water nanoemulsion in which oil is dispersed in water, (b) water in oil nanoemulsions in which water droplets are dispersed in oil, and (c) bi-continuous nanoemulsions.”

Nanoemulsion Research Studies

Although a relatively new technology, serious peer-reviewed research reports have begun to emerge regarding nanoemulsions. These study results consistently demonstrate significantly greater bioavailability, including shorter onset periods and enhanced peak potency. Nanoemulsion tech has shown this effect for a variety of cannabis-derived compounds, including CBD.

A 2016 study entitled “Nanoemulsions: Formation, Properties, and Applications” that was published in the journal Soft Matter noted a number of advantages to the use of nanoemulsion technology for delivery of drugs, including a small size that “leads to useful properties such as high surface area per unit volume, robust stability, [and] optically transparent appearance.” 

The research also noted the different forms of drug delivery in which nanoemulsion technology can improve bioavailability, which include “topical, ocular, intravenous, internasal, and oral delivery.” 

The study reported that most nanoemulsions are transparent in appearance because the droplet size employed “is significantly smaller than the wavelength of visible light.” However, the researchers noted that product and drug formulators “can easily tune the appearance of nanoemulsions to range from transparent to milky white” through the adjustment of droplet size. 

A 2017 study entitled “Biocompatible Nanoemulsions Based on Hemp Oil and Less Surfactants for Oral Delivery of Baicalein with Enhanced Bioavailability” that was published in the International Journal of Nanomedicine aimed to “probe the potential of nanoemulsions consisting of hemp oil in ameliorating [improving] the oral bioavailability of [the flavonoid] baicalein.” 

The study involved a particle size of 90 nm and an impressive bioavailability (what the study called an “entrapment efficiency”) of 99.31 percent. It reported that the flavonoid’s oral bioavailability was increased by “up to 524.7 percent and 242.1 percent relative to the suspensions and conventional emulsions, respectively.” 

The research determined that the safety profile of the flavonoid-based nanoemulsion revealed safe oral consumption. “Our findings suggest that such a novel…preparative process provides a promising alternative to current formulation technologies” and that nanoencapsulation is suitable for “oral delivery of drugs that feature…bioavailability issues.”

A 2017 study entitled “Nanoemulsion: A Novel Eon in Cancer Chemotherapy” that was published in the journal Mini Reviews in Medicinal Chemistry investigated the role of nanoemulsions in the effective treatment of cancer. 

The study’s authors observed that nanoemulsions offer a new approach to improving the sometimes poor bioavailability issues that have plagued traditional preparations and formulations for generations. Reported the study, “the research fraternity has acknowledged nanoemulsions as…capable of effectively addressing the low bioavailability…issues associated with conventional anticancerous chemotherapeutic dosage forms.”

A 2019 study entitled “Development of a Novel Nano­emulsion Formulation to Improve Intestinal Absorption of Cannabidiol” that was published in the journal Medical Cannabis and Cannabinoids observed the relatively poor bioavailability of CBD when ingested orally. “Cannabidiol (CBD) is highly lipophilic [fat loving] and its oral bioavailability is known to be very low in humans.” 

The study developed a novel nanoemulsion preparation of CBD involving a droplet size of approximately 35 nm “to improve the poor solubility and absorption of CBD.” The research reported that significant improvements in bioavailability were afforded by the nanoemulsification process. The period to achieve peak bioavailability (delay from time of consumption) was shortened by 330 percent and its potency was increased by 65 percent compared to a traditional non-nanoemulsified CBD oil. 

The study’s authors observed that their research was “the first to develop a CBD-based nanoemulsion formulation for testing,” which they observed to “extensively enhance the absorption of CBD and improve its bioavailability.”

A 2019 study entitled “Quercetin Loaded Nanoemulsion-based Gel for Rheumatoid Arthritis” that was published in the journal Biomedicine & Pharmacotherapy explored the advantages of a nanoemulsified topical application for the treatment of arthritis. 

The study found the nanoemulsified gel to feature improved bioavailability and “confirmed adequate rheological behavior with a good texture profile and improved drug permeation.” The report’s authors concluded that the nanoemulsified gel featuring the flavonoid quercetin “is an efficient topical treatment strategy for rheumatoid arthritis.” 

A 2019 study entitled “Emulsiogenesis and the Emergence of Nanoemulsions” that was published in the journal Matter investigated “the origin of the first natural emulsions and the evolution in production, classification, and nomenclature of extremely fine colloidal emulsions.”

The study reported that the first emulsions in nature appeared without the help of homo sapiens (and long before their appearance on the planet), about three to four billion years ago. It detailed how the emergence of waterborne microbes “produced organic hydrocarbon molecules, which were large enough in molar mass that collections of [them] formed liquid oil droplets surrounded by water.”

The researchers explained how the history of human-crafted emulsions dates back more than one hundred years. “Small-scale emulsions have been the subject of serious scientific investigations for more than a century, leading to very important milestones in condensed matter.”

The study emphasized how nanoemulsion tech remains in its infancy and that future developments will lead to novel and commercially enticing methods of encapsulating particular types of molecules for storage, distribution, and consumption—all while maintaining maximum bioavailability. 

“Regardless of the trends in nomenclature used for classifying emulsions, it is clear that emulsions having the smallest attainable droplet sizes, increasingly complex chemical compositions, and even multiple internal compartments represent a fertile area for basic research and important applications over many decades to come,” concluded the study’s authors. 

It’s a Wrap

Nanoemulsion technology offers patients and lifestyle consumers—and the companies that serve them—a way to encapsulate wellness molecules such as CBD, CBG, and THC that features improved stability and greater bioavailability than more traditional formulation techniques, including standard oils and liposomes. 

Heavily regulated industries such as hemp and cannabis benefit significantly from products that are formulated in a manner that leads to maximum shelf life and that can ensure sometimes lengthy storage periods. Greater bioavailability, in turn, offers both lifestyle consumers and multiple patient populations the advantage of rapid onset and enhanced potency. Medical professionals and caretakers are demonstrating an affinity for nanoemulsions based on not only enhanced bioavailability, but also more accurate dosing.   

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How CBD Can Help with Skin Problems

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Anyone who’s suffered throughout their life with uncooperative skin has probably looked at many solutions to their troubles. Once they’ve exhausted other more obvious solutions, they may then cast a jaded eye towards skin cream that includes CBD as a significant ingredient.

What they may not understand clearly is whether a cream containing CBD will be helpful to them or not. Therefore, this article is aimed at providing some clarity on this issue.

One Itch or Three?

While it’s natural for the skin to itch when it is healing, it’s not as common or comfortable when that’s not the root cause. In which case, you’re trying to not scratch the area, but the itching is driving you’re a bit nutty!

If you’ve already tried antihistamine tablets and it didn’t do anything for you, then perhaps a cream with CBD will be worth trying now?

How will CBD help in this situation? Good question. What it does is disable the signal that’s communicating from the brain to your skin to create the itchy sensation. As a result, it’s felt less or removed entirely.

Protect the Skin from Damage

When out and about in the spring and summer months, being exposed to sunlight is almost inevitable. UV rays can cause cellular damage to the skin that’s irreversible and will eventually catch up with you. This is why sunbathing is detrimental, no matter how attractive a tan is.

The use of CBD cream can assist in preventing free radicals from UV rays that cause damage to the skin. When there’s no sun cream to hand, this alternative is great.

Remedy for Skin Breakouts

Chronic skin problems including minor to major breakouts are a real bugbear. Even if you’re a woman and able to cover over them with makeup, it’s still far from perfect. It’s also possible that the makeup will cause further skin irritation that won’t help either.

CBD cream helps with skin issues because it can reduce the build-up of oils on or below the surface that cause blocked pores in the first place. For people who suffer from an excess of oil on the skin that frequently creates fresh skin dilemmas, the use of CBD creams can reduce the frequency and severity of skin problems.

Avoid Aging as Rapidly

Avoiding aging is important to all of us. While we cannot stop the passage of time, we can at least try to stop our skin from looking significantly older.

CBD contains many antioxidants that shield the skin from harm including environmental-related damage. UV rays and air pollution are prevented from prematurely aging the skin when the cream is applied. Dark areas, fine lines, and pronounced wrinkles may be delayed as a result.

While no treatment is a cure-all for the way that the environment, pollution, and UV rays can ravage the skin, CBD cream provides added defense against them. Along with an effective cleaning and cleansing regimen, it can prove effective in keeping the skin looking its best.

 

 

Jazz Pharmaceuticals To Acquire GW Pharmaceuticals, Creating An Innovative, High-Growth, Global Biopharma Leader

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UNITED KINGDOM: Jazz Pharmaceuticals plc and GW Pharmaceuticals announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

Charlotte’s Web Secures U.S. Utility Patents For Two New Hemp Varietals With Superior Cannabinoid Expression

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COLORADO:  Charlotte’s Web Holdings, Inc. (“Charlotte’s Web” or the “Company”), the market leader in hemp CBD wellness products, announces that Charlotte’s Web, Inc., a wholly-owned subsidiary, has been granted U.S. Utility Patents for its hemp genetics by the United States Patent and Trademark Office. The newly issued patents cover two of the Company’s new feminized seed hybrid hemp varieties developed under the Company’s breeding program; ‘Kirsche’ (US Patent No. 10,888,060) and ‘Lindorea’ (US Patent No. 10,888,059).  ‘Lindorea’ and ‘Kirsche’ are the world’s first two allowed U.S. Utility Patents reading on feminized hybrid hemp plants.

TSX:CWEB - Charlotte's Web is the market leader in hemp CBD extract products and is a Certified B Corp publicly traded company with five patent awards.. (CNW Group/Charlotte's Web Holdings, Inc.)

The Company now has earned a total of five U.S. hemp variety patent grants: one Plant Patent and four Utility Patents as it advances the science of hemp horticulture.

“Achieving the first patented hemp hybrids demonstrates that it is possible to improve hemp through similar methods as other agronomic crops using natural breeding techniques.  We believe that ‘Kirsche’ and ‘Lindorea’ are some of the hardiest botanical hemp varietals under cultivation.” said Bear Reel, Charlotte’s Web vice president of cultivation and R&D and the developer of the new varietals.

‘Kirsche,’ having a naturally rich phytochemical profile and good disease resistance, has an excellent plant structure and a flower-to-stem ratio that is compatible with mechanical harvesting innovations. ‘Lindorea,’ developed for the Kentucky climate, exhibits broad resistance to fungal pathogens in the North and South Appalachian regions but also in the wetter autumn climate in Ore. while delivering record breaking yields.

“The ‘Kirsche’ and ‘Lindorea’ U.S. patents represent more than four years of scientific research and trials, and some of the most cutting-edge work being conducted in genetics in the hemp CBD industry today,” said Deanie Elsner, Charlotte’s Web president and CEO. “Charlotte’s Web will continue to advance and protect our prized hemp varietals to build consumer confidence in the consistency of our hemp extract products. This is at the heart of our mission to advance the science of hemp for the greater benefit of the people who choose these products for their wellness needs.”

Truss CBD USA, A HEXO Corp & Molson Coors Joint Venture, Launches Veryvell Sparkling CBD Water In Colorado

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CANADA:  Truss CBD USA, a joint venture between HEXO Corp and Molson Coors Beverage Company, today announced the U.S. launch of VeryvellTM, a new line of non-alcoholic, sparkling CBD beverages, exclusively available in Colorado.

VeryvellTM is a hemp-derived, adaptogenic, sparkling CBD water now available to Colorado-based consumers in three flavours: Focus (Grapefruit Tarragon), Mind & Body (Strawberry Hibiscus) and Unwind (Blueberry Lavender). VeryvellTM is Powered by HEXOTM, the recognized quality and innovation behind award-winning products.

“We are excited to launch VeryvellTM in Colorado through Truss CBD USA, in collaboration with our partner, Molson Coors. Our joint venture with Molson Coors Canada saw Truss Beverage Brands become the number one choice for consumers in Canada and we are expecting similarly great results in the US.” said HEXO CEO and co-founder Sebastien St-Louis. “We have near-term plans to invest additional capital in the USA to support Truss CBD USA and to further execute on our Powered by HEXOTM strategy with other potential CPG partners, outside of beverages, with whom we are currently in ongoing negotiations.”

VeryvellTM is produced and distributed within Colorado state lines following the state’s established regulatory framework for hemp-derived CBD in food and beverages and is exclusively distributed by Coors Distributing Company. Truss CBD USA is distinct from Truss Beverages, Molson Coors and HEXO’s joint venture in Canada that focuses on non-alcoholic, cannabis-infused beverages.