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Aphios Corporation today announced receipt of a Phase I Small Business Innovative Research (SBIR) grant from the National Institute on Drug Abuse (NIDA) to develop an improved oral formulation of Δ9-THC for marijuana addiction and unmet medical needs.
According to Dr. Trevor P. Castor, the grant's Principal Investigator, "In addition to helping marijuana addicts overcome their addiction, the nanotech formulation of Δ9-THC will have applicability in several other chronic diseases such as cancer pain, AIDS wasting, emesis, cachexia, obesity, smoking cessation, schizophrenia, multiple sclerosis and Parkinson's disease."
Innovative and novel dosage formulations are needed to improve the effectiveness and/or minimize the abuse potential of therapeutic agents for drug abuse/dependence. Examples of such agents are buprenorphine and delta-9-tetrahydrocannabinol (Δ9-THC). Buprenorphine has been approved for the treatment of opioid dependence. Sustained-release formulations that reduce the dosing frequency to once a week or once a month are expected to improve compliance thus effectiveness of treatment. Δ9-THC has been shown to alleviate marijuana withdrawal symptoms and has potential for treating marijuana dependence.
In the currently marketed formulation, synthetic Δ9-THC (Dronabinol®) is dissolved in sesame seed oil and is commercially available as an oral capsule (Marinol®). Oral administration causes slow, variable Δ9-THC uptake. In addition, it also requires drug administration several times a day. Δ9-THC is very hydrophobic and oxygen-sensitive, both factors that are challenges in making formulations that are orally bioavailable and stable. Formulations to improve bioavailability and reduce dosing frequency are expected to improve therapeutic effectiveness of Δ9-THC for marijuana addiction.
Aphios plans to utilize its patented SFS-CXP manufacturing technology platform to manufacture pharmaceutical grade Δ9-THC with a >99% purity following cGMP. Aphios will then utilize patented polymer nanospheres nanotechnology platform (SFS-PNS) to encapsulate Δ9-THC in biodegradable polymer nanospheres. Nanoencapsulation will protect Δ9-THC transport to the stomach and enhance its passage across the stomach lining of the gut. Nanoencapsulation will also slow the release of Δ9-THC, controlling the amount of drug in the bloodstream and reducing the frequency of drug administration during the day. Nanoencapsulation in biodegradable polymer nanospheres will thus improve Δ9-THC's stability, prolong circulation time and enhance bioavailability. Alternatively, the formulation will be utilized to deliver Δ9-THC from a subcutaneously implanted depot.
The project described herein was supported by Grant Number 1R43DA024552-01 from the National Institute on Drug Abuse. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute on Drug Abuse or the National Institutes of Health.
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Trevor P. Castor, Ph.D.
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