cbd usp

Cannabidiol (CBD) is a marijuana compound implicated in epilepsy treatment in animal models and pharmacoresistant patients. However, little is known about chronic CBD administration’s effects in chronic models of seizures, especially regarding its potential antiepileptogenic effects. In the present study, we combined a genetic model of epilepsy (the Wistar Audiogenic Rat strain – WARs), a chronic protocol of seizures (the audiogenic kindling – AuK), quantitative and sequential behavioral analysis (neuroethology), and microscopy imaging to analyze the effects of chronic CBD administration in a genetic model of epilepsy. The acute audiogenic seizure is characterized by tonic-clonic seizures and intense brainstem activity. However, during the AuK WARs can develop limbic seizures associated with the recruitment of forebrain and limbic structures. Here, chronic CBD administration, twice a day, attenuated brainstem, tonic-clonic seizures, prevented limbic recruitment, and suppressed limbic (kindled) seizures, suggesting CBD antiepileptogenic effects. Additionally, CBD prevented chronic neuronal hyperactivity, suppressing FosB immunostaining in the brainstem (inferior colliculus and periaqueductal gray matter) and forebrain (basolateral amygdala nucleus and piriform cortex), structures associated with tonic-clonic and limbic seizures, respectively. Chronic seizures increased cannabinoid receptors type 1 (CB1R) immunostaining in the hippocampus and the BLA, while CBD administration prevented changes in CB1R expression induced by the AuK. The neuroethological analysis provided details about CBD’s protective effects against brainstem and limbic seizures associated with FosB expression. Our results strongly suggest chronic CBD anticonvulsant and antiepileptogenic effects associated with reduced chronic neuronal activity and modulation of CB1R expression. We also support the chronic use of CBD for epilepsies treatments.

Keywords: Anticonvulsant; CB1 receptors; Cannabidiol; Epilepsy; Neuronal activity; Preclinical model.

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Cbd usp

Chromatography methods are also applicable in the determination of terpene compounds and ratios, which can be used in the identification of cannabis varieties (4). The USP Cannabis panel is suggesting analysis of the five most prevalent terpenes found in cannabis (one sesquiterpene: β-caryophyllene and four monoterpenes: D-limonene, β-myrcene, α-pinene, and γ-terpinolene) can provide valuable identity information. Each of these terpenes has appeared as the dominant or codominant terpene in various varieties of cannabis, which could aid in confirmation of identity.

Despite the fact that cannabis is treated like the newest botanical product to come to market in decades, cannabis has a long-standing history going back before 3000 B.C. with the first recorded uses in China. Early cannabis products were hemp fibers and medicinal treatments were prescribed by ancient Greek and Roman physicians. In the 16th and 17th centuries the use of cannabis continued and increased with its expansion to the Americas in the 1600s.

Toxic elements and heavy metals are another source of contamination in dietary supplements and botanical products. Cannabis is an effective concentrator of heavy metals. Impurities from environmental and other sources accumulate in the plant and then pose health risks for patients and consumers. For elemental impurities, USP has several chapters pertaining to heavy metal limits and testing, including limits for both dietary supplements (USP <2232>) and pharmaceuticals (USP <232>) (Table I).

The USP was founded in 1820 by physicians whose intent was to bring a national set of standards to the US that would unify the quality of drugs in the nation. At the time of the initial organization of the USP, most drugs were based on botanical or mineral ingredients. The US needed its own compendium or pharmacopeia (a compilation of standards and quality specifications that can test to confirm: composition, identity, purity, and strength of specified materials for use in medicines and food products) (2). The first national Pharmacopoeia of the United States of America (1820) contained a list of 217 drugs that included 145 botanicals and botanical products.

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More than 150 countries around the world recognize and use the standards published by USP. Despite its legal recognition by US agencies, the USP is an independent organization. The USP is an “organization of organizations” with its own governance and membership and broad stakeholder engagement that direct and inform their activities and produce guidance documents for food, pharmaceutical, and dietary supplement and herbal medicine industries which include botanicals.

The first entry in 1850 was titled: “Extractum Cannabis. Extract of Hemp.” This form was an alcohol based extract of “Cannabis sativa – variety Indica” composed of the dried tops of the plants. USP V (1870) separated cannabis species into the flowering tops of C. sativa grown in North America and the flowering tops of C. sativa var. indica from India. Cannabis extracts remained in the USP up until USP XII (1940) when it was criminalized by the 1937 US Marijuana Tax Act (Figure 4).

The USP is an independent, nonprofit organization outside of the US government whose purpose according to their missions statement (1) is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”

The USP’s Role in Botanicals

In 1906, the US Pure Food and Drug Act required labeling products that contained psychogenic substances such as cannabis and alcohol. By 1914, the Harrison Act (US) made the use of marijuana (a variety of cannabis that contains higher levels of tetrahydrocannabinol [THC]) and other narcotic drugs a crime. Starting in 1915 through the 1930s the prohibition and criminalization of cannabis continued all over the world. In 1937, the US Marijuana Tax Act criminalized cannabis without distinguishing between cannabis with psychotropic properties or species used for hemp products (1).

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While the early editions of USP were always considered authoritative they were not officially or legally recognized in the US until a series of legislative acts: 1848 Drug Importation Act, the 1906 passage of the Food and Drug Act, and the 1938 Food, Drug and Cosmetic Act. The final act decreed that all medicines sold in the US must meet USP quality standards in what is now known as the USP-NF.