IBOGAINE

Background

Purpose

Ibogaine’s unique and complex pharmacological properties, including binding on receptors sites as an agonist (hallucinogenic) and antagonist (anti addictive).These properties support its promising use in treating alcohol use disorders and some CNS conditions.

Preclinical studies demonstrated that ibogaine reduces self-administration of both cocaine and morphine in laboratory animals, and attenuates the symptoms of morphine withdrawal. This data encourages health authorities to support several clinical studies of ibogaine in the US and some other countries. 

Clinical trials

The use of pharmaceutical (cGMP grade) Ibogaine in research is hindered by the scarcity of the natural product (protected plant Tabernanthe iboga) and also by its CI controlled status in most countries of the world. In some cases non-GMP grade (“grey market”) Ibogaine is used for preclinical and Phase I & II clinical trials. However, for NDA and Phase III trials, the use of cGMP material remains mandatory. Therefore, it is of great importance of using cGMP Ibogaine from the earliest possible stage of drug development. 

CORYN Pharmaceuticals LLC, which specializes on natural alkaloids, is one of a few companies which established cGMP manufacturing of ibogaine. Coryn offers both the base and the HCl salt of ibogaine to the duly licensed research organizations and laboratories to support drug product development and clinical trials according to the FDA standards. 

CORYN IS DEVELOPING LSD PROJECT

Lycergic acid diethylamide (LSD) has gained renewed interest for potential treatment for neuropsychiatric disorders as it is considered to act as a psychoplastogen, promoting neuronal growth by activating AMPA receptors. In addition, the remarkable property of LSD to act as an anxiolytic through the modulation of fear circuits and its disruptive action on addictive patterns lays the ground for LSD use as a potential new opportunity to address conditions like major depressive disorder, anxiety, and addiction.

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CYTISINE

History

Cytisus laburnum was known already from antiquity and, as Gaius Plinius Secundus (also known as Pliny the Elder) reports in his encyclopedic book Naturalis Historia v.III, Cytisus laburnum was cultivated for its beauty, and pharmaco-toxicological properties.

Known also as golden rain tree, common in northern Europe and the mountains of southern Europe, Cytisus has all its parts poisonous but especially the seeds.

This is due to many alkaloids present in the plant but, especially to the alkaloid Cytisine.

Cytisine was first discovered in 1818 and was isolated in 1865. Since 1950-s citisine was used as a cough suppressant in a form of herbal tablets and become (in 1964) the first anti-tobacco agent available in some East European states. Citisine, being a partial agonist at alpha 4 beta 2 to nicotinic receptors in the brain due to its chemical structure close to that of nicotine, makes this substance an attractive remedy to support quitting smoking. It alleviates the urge to smoke tobacco and reduce nicotine withdrawal symptoms. 

Purpose

Nowadays and during the last two decades, clinical trials based on modern clinical protocols have conclusively assessed the efficacy of cytisine in maintaining abstinence from smoking (nicotine).

Cytisine is already sold in a number of European states (including UK) and Canada either as an OTC or as a prescription drug whereas its salts are under process to obtain the prerequisite FDA authorization and to be marketed in the USA.

Supply

Cytisine is a challenging substance and its synthesis from basic chemicals is tedious and economically unattractive. The presence of several stereochemical centers add complexity to its synthesis rendering the supply solution from extraction from plant material almost inevitable.

Coryn Pharmaceuticals LLC is supplying customers cGMP cytisine, which is extracted from Laburnum, in gram to kilogram scale.

Noteworthy, cytisine is not a controlled substance and therefore no special permit for import/export, handling and storage is required.

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YOUR LEADING MOLECULES

CORYN Pharmaceuticals, which is specialized in extraction technology and natural APIs manufactured under cGMP conditions, can assist your organisation in supply chain of your Clinical Trials (Ph I-V) by extracting and/or synthesizing, your leading molecules and specifically those originating from controlled plant material or derived from CI compounds, at gram to kilogram scale quantity. 

The sources that CORYN includes are opium extract (CPS), pure opium alkaloids (morphine, codeine, papaverine, thebaine, noscapine, narcotine, narceine) and downstreams (oxycodone, hydrocodeine, hydromorphone, oxymorphone, naloxone, naltrexone, nalmefene). 

Additionally, plant materials with legally restricted access such as Mitragyna speciosa (mitragynine, 7-Hydroxymitragynine), psychedelics as Voacanga africana (Ibogaine, noribogaine) and Argyreia nervosa (Lysergic acid, LSD) are also considered in projects for the extraction and/or synthesis of your potential leads.  

CORYN also assists in your drug development project by providing non-controlled, cGMP extracted hyoscyamine and scopolamine as sources of tropane-sceleton building blocks useful for the synthesis of lead candidates for the treatment of substance use disorder (SUD); severe depression (SD) and post traumatic stress disorder (PTSD) conditions.

Projects involving the non-controlled cGMP cytisine (smoking cessation) are also foreseeable as CORYN handles raw material sourcing.

Finally, CORYN can suggest the formulator specialist to assist your R&D for the choice of the appropriate dosage form and its manufacturing, of your leading drug candidate for your Clinical Trials.

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Contact Info & Price Quote*: info@coryn-pharma.com

(*) Coryn provides cGMP and GLP material suitable for clinical studies and R&D projects and drug product development to clients who provide appropriate certificates related to handling a controlled substance

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CORYN Pharmaceuticals LLC, 10 Shipyard drive, Suite 202, Hingham (MA) 02043 – USA