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Zindol®
Despite
the widespread use of the 5-HT3 receptor antagonist antiemetics,
post-chemotherapy nausea and vomiting continue to be reported
by up to 70% of patients receiving highly emetic chemotherapy
agents, such as cisplatin, carboplatin and doxorubicin. Furthermore,
these antiemetics have been associated with significant adverse
effects, such as sedation, extra-pyramidal side effects and
hypotension (associated with dopamine antagonists), as well
as headache, diarrhea or constipation. A desirable attribute
in any substitute or additional antiemetic medication would
be the absence of clinically significant adverse effects.
Since the 16th century,
practitioners of both Indian (Ayurvedic) and traditional Chinese
medicine (TCM) have used ginger (Zingiber officinale Roscoe)
to treat gastro-intestinal upsets such as nausea and excessive
flatulence. North American folklore also recognizes the ability
of ginger to relieve gastrointestinal upsets including nausea.
Ginger is believed to be the only herb that can prevent symptoms
of motion sickness.
Ginger has
been approved for that use by Germany’s Commission E,
the agency responsible for regulating the use of herbal products
in that country. Ginger has recently been studied scientifically
for its effect on nausea and vomiting associated with motion
sickness, surgery and pregnancy. Ginger is listed as a GRAS
(generally regarded as safe) food by the U.S. FDA.
Zindol®
is an enhanced ginger product that is standardized by the
bioactive constituents, gingerols and shogaol, of ginger.
Aphios’ scientists and engineers utilize polarity-guided
Super-Fluids™ [SFS] CXF fractionation technology to
establish conditions for the isolation of the active ingredients
of Zindol® [US Patents 5,854,064; 6,569,640]. The technology
is then scaled-up to manufacture the active pharmaceutical
ingredients utilizing patented SFS-CXP manufacturing tech-nologies
[US Patents 5,440,055; 5,750,709].
We use
organically grown ginger and SuperFluids™ carbon dioxide
to selectively extract and concentrate gingerols and shogaol.
These extracts are thus free of potentially toxic organic
solvents, and are tested and certified to be free of pesticides,
herbicides and other contaminants. 
The enhanced
ginger concentrate is then formulated to achieve a specific
concentration of gingerols and shogaol with all-natural liquid
excipients designed to maximize the stability and bioavailability
of the bioactive constituents [US Patent Pending]. The golden-brown
formulation is then encapsulated into gel capsules (LiCaps™)
with a nitrogen head by Capsugel, Inc., a subsidiary of Pfizer
following cGMP.
Zindol®
was recently evaluated in a multi-center, 644-patient, dose-finding,
placebo-controlled, randomized Phase II/III clinical trial
as an adjunctive therapy to conventional 5-HT3 anti-emetics
for nausea in cancer patients undergoing chemo-therapy. This
successful clinical trial was managed by the University of
Rochester.
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