| Symbollon has developed
proprietary iodine technology that the Company believes maximizes
the “therapeutic
index” of iodine. The “therapeutic index” of a
drug is the ratio of the largest safe dose to the smallest effective
dose. Iodine has been shown to be a rapid acting, broad-spectrum
antimicrobial and an effective therapeutic for certain pharmaceutical
applications. The Company’s technology accomplishes this by
controlling the ratio of molecular iodine, to the other inactive
species of iodine typically present in solution. The Company believes
that this will enable it to produce iodine-based applications having
advantages over currently available products.
The stability of molecular iodine is the principal constraint
that has limited previous iodine-based formulations. Our approach
to the formulation of molecular iodine is fundamentally different
from older compositions. Unlike other iodine-based therapeutics,
our dosage forms do not contain any molecular iodine per se;
rather, our compositions rely upon diverse chemical mechanisms
to generate molecular iodine from precursor molecules. This formulation
strategy has several significant advantages not the least of
which is the ability to develop stable dosage forms that deliver
molecular iodine without contamination from other iodine species.
Our in situ iodine generation formulation strategy has a number
of consequences. Symbollon’s formulations generate significantly
higher levels of molecular iodine while requiring less total
iodine to achieve a given efficacy objective. Thus, Symbollon’s
formulations are less toxic than comparable dosage forms that
contain mixtures of different iodine species. The raw material
cost associated with dosage forms based on Symbollon’s
in situ iodine generation is frequently lower due to a reduced
requirement for iodine. The epithet "champagne in a tin
cup" has previously been applied to traditional iodine-based
formulations because of the elevated ratio (often 10,000 to 1)
of ineffective iodine species to molecular iodine that exists
in these preparations. We have reversed this ratio in our dosage
forms and are using this core technology to develop a series
of products.
IodoZyme, an animal drug, is the first product that incorporated
in situ molecular iodine generation. IodoZyme is a powdered product
that uses the enzyme horseradish peroxidase to enzymatically
form molecular iodine upon dissolution in water. IodoZyme has
been used in the United States by dairy farmers since 1995 and
is sold in the United Kingdom. The experience gained from 10
years of manufacturing IodoZyme has been invaluable in assisting
our efforts to commercialize other products.
IoGen is the first solid oral dosage form that delivers molecular
iodine upon dissolution in gastric fluid. This in situ generation
approach to IoGen insures an unassailable stability profile for
the drug. IoGen solves the long-standing problem of providing
an oral dosage form for molecular iodine that is stable, tasteless
and well tolerated.
IoDerm is a topical gel formulation that provides molecular
iodine upon admixture. IoDerm is the first of a new class of
iodine-based topical formulations that will not stain skin but
provides over 100 times more biocidal iodine than traditional
iodophors. We believe this improved therapeutic index will allow
IoDerm to address several unmet market needs.
| 
