Aphios
Awarded SBIR Grant from National Institute on Drug Abuse
(NIDA) for Nanotech Formulation of Δ9-THC
for Marijuana Addicition and Other Unmet Medical Needs
October
28, 2008 —
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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