Chemical structure of tetrahydrocannabinol

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Dronabinol

Tetrahydrocannabinol, also known as THC, Δ⁹-THC, Δ⁹-tetrahydrocannabinol (delta-9-tetrahydrocannabinol), Δ¹-tetrahydrocannabinol (using an older numbering scheme), or dronabinol, is the main psychoactive substance found in the Cannabis plant. It was isolated by Raphael Mechoulam and Yechiel Gaoni from the Weizmann Institute in Rehovot, Israel in 1964. In pure form it is a glassy solid when cold and becomes viscous and sticky if warmed. more...

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THC has a very low solubility in water, but a good solubility in most organic solvents such as pure ethanol or hexane.

Pharmacology

Its pharmacological actions are the result of its binding to the cannabinoid receptor CB1, located in the brain. The presence of these specialized receptors in the brain implied to researchers that endogenous cannabinoids were manufactured by the body, so the search began for a substance normally manufactured in the brain that binds to these receptors, the so-called natural ligand or agonist, leading to the eventual discovery of anandamide and some related compounds. This story resembles the discovery of the endogenous opiates (endorphins, enkephalins, and dynorphin), after the realization that morphine and other opiates bound to specific receptors in the brain.

Effects include: relaxation, euphoria, altered space-time perception, alteration of visual, auditory, and olfactory senses, disorientation, fatigue and appetite stimulation. It also has anti-emetic (anti-nauseant) properties.

Toxicity

THC has a LD₅₀ value of 1270 mg/kg (male rats) and 730 mg/kg (female rats) administered orally dissolved in sesame oil.

If this were scaled up to an adult human, the lethal dose would be between approximately 50 and 86 g for a 68 kg (150 lb) person. This would be equivalent to 1-1.8 kg of marijuana with a 5% THC content (roughly average) taken orally (much more if smoked). It is important to note, however, that toxicity studies in animal models do not necessarily correlate to human toxicity. THC receptor distribution in the rat CNS is different than that of humans, meaning that there is the significant possibility that toxicity in humans varies from the published animal LD50 studies. There has never been a documented fatality from marijuana or THC overdose.

Studies of the distribution of the cannabinoid receptors in the brain explain why THC's toxicity is so low (i.e., the LD₅₀ of the compound is so large): parts of the brain that control vital functions such as respiration do not have many receptors, so they are relatively unaffected even by doses larger than could ever be ingested under any normal conditions.

Research

A number of studies indicate that THC may provide medical benefits for cancer and AIDS patients by increasing appetite and decreasing nausea, and by blocking the spread of some cancer-causing Herpes simplex viruses. It has been shown to assist some glaucoma patients by reducing pressure within the eye, and is used in the form of cannabis by a number of multiple sclerosis patients to relieve the spasms associated with their condition. Government studies indicate a variety of negative effects associated with constant, long-term use, including memory loss, depression and loss of motivation. The long-term effects of THC on humans have been disputed because its status as an illegal drug almost everywhere prevents free research into the subject. The issue has become deeply politicized.

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Unimed Pharmaceuticals, Inc. and Inhale Therapeutic Systems, Inc. Announce Collaboration to Develop Inhaleable Medicinal Dronabinol
From Business Wire, 2/26/02

Business Editors, Health/Medical Writers

SAN CARLOS, Calif.--(BUSINESS WIRE)--Feb. 26, 2002

Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., and Inhale Therapeutic Systems, Inc. (Nasdaq:INHL) today announced that they have entered into a collaboration to develop a metered dose inhaler (MDI) of dronabinol (synthetic delta-9-tetrahydrocannabinol) to be used for multiple indications.

Dronabinol is the active ingredient in Unimed Pharmaceuticals' product MARINOL(R) Capsules. MARINOL(R) Capsules is synthetic delta-9-tetrahydrocannabinol. MARINOL(R) is approved in the US and is indicated for the treatment of anorexia associated with weight loss in patients with AIDS and for the treatment of refractory nausea and vomiting associated with cancer chemotherapy.

"We are pleased that Unimed will be partnering with us to develop this inhaleable dronabinol, as they have the history and knowledge with this product and its patient base," said Ajit Gill, president and CEO of Inhale. "This will be our first MDI development program and is the third inhaleables development program we have signed in the last five months. We believe that Unimed's decision to partner with Inhale is an endorsement of the breadth of our Inhance(TM) pulmonary delivery platform and Inhale's expertise in the inhaleables field."

"Inhale has a great deal of expertise in the development of aerosol medicine," said Jean-Louis Anspach, president and chief executive officer of Unimed. "They have developed a range of products that include inhaleable proteins and small molecules using a variety of drug processing and delivery devices. We are confident that they will help us develop the most appropriate product to bring to market in the least amount of time."

Under the terms of the collaboration, Inhale will be responsible for development of the formulation, as well as clinical and commercial manufacturing of the drug formulation and inhaler combination. Unimed, a wholly owned and independently operated subsidiary of Solvay Pharmaceuticals, Inc., will be responsible for the clinical development and worldwide commercialization of the system. Inhale will receive research and development funding, milestone payments as the program progresses through further clinical testing, and royalty payments and manufacturing revenues when the product is commercialized.

Unimed Pharmaceuticals, Inc., (www.unimed.com) a wholly owned, independently operated subsidiary of Solvay Pharmaceuticals, Inc., focuses on drugs with multiple indications in the therapeutic areas of men's health (urology and endocrinology) and certain infectious diseases. Unimed Pharmaceuticals, based in the Chicago, Illinois area, has expertise in ethical drug development.

Solvay Pharmaceuticals, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia, is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay S.A. chemical and pharmaceutical group, headquartered in Brussels, Belgium.

Inhale Therapeutic Systems, Inc., provides a portfolio of leading performance-enabling drug delivery technologies and expertise to help pharmaceutical and biotechnology companies maximize the performance of their compounds. Inhale offers three leading drug delivery platforms: a suite of technologies for the inhaleable delivery of macromolecules and small molecules for systemic and local lung delivery; supercritical fluid powder particle engineering to easily control particle size for a variety of drug delivery applications; and PEGylation for enhanced delivery performance of most major drug classes. The company is collaborating with major pharmaceutical and biotechnology companies, including Amgen, AstraZeneca, Aventis Behring, Bristol-Myers Squibb, Chiron, Enzon, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, Pharmacia, Roche, Schering-Plough and Serono.

This release contains forward-looking statements that reflect the current views of Inhale management as to future products, product development, and other future events and operations. These forward-looking statements involve uncertainties and other risks that are detailed in reports and other filings with the Securities and Exchange Commission, including Forms 10-K as amended for 2000. These documents identify important factors that could cause the companies' actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness.

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