| Services
 CritiTech
offers contract processing of fine-particle pharmaceutical
compounds for drug manufacturing companies and biotechnology
industries. Our company can help create solutions to problems
dealing with insolubility issues of new chemical entities,
and may make possible the reformulation of already-approved
drugs that exhibit undesirable side effects due to formulation.
Small investments in exploration of the
use of our technologies can result in dramatic increases in
the number of potential new drugs that the client company
can investigate; even an occasional success may constitute
a major market.
CritiTech's process, known as Precipitation
with Compressed Antisolvents, or PCA, demonstrates the ability
to recrystallize a large variety of small-molecule and biotechnology
drugs. The process consistently produces particles in the
size range of 600 nanometers to two microns, and includes
a method to harvest these particles on a continuous basis.
Through experiments on various drugs, CritiTech's researchers
have gained an understanding of the parameters that control
particle size and harvested yield.
CritiTech's technology represents a new
approach to the production of fine-particle pharmaceuticals
that can be used for delivery of drugs via both pulmonary
and injection delivery routes. The patented SCF processing
and compound-harvesting technologies that underpin CritiTech's
methods have a unique combination of strengths: they are efficient,
they are inherently safe, and they are friendly to the environment.
The process of producing nanoparticulate
drugs begins with a research contract to determine the conditions
under which the client's drug can be manufactured as nanoparticles.
The client will provide the drug in bulk form along with sufficient
information to identify a suitable solvent for the drug. CritiTech
will use this material and information to produce test batches
of the client's drug as nanoparticulate material. The nanoparticulate
material is returned to the client for bioavailability and
other testing and in an iterative process an optimal formulation
is developed.
At this stage, a second contract would
be negotiated to produce adequate amounts of the nanoparticulate
drug under GMP conditions to perform Phase I and/or Phase
II clinical trials. If these trials were successful, production
would then be scaled up to produce amounts adequate for phase
III clinical trials.
When a prospective drug successfully achieves
Market Approval, CritiTech will receive revenues as determined
by the agreements negotiated during the Phase I-III studies.
CritiTech will also generate GMP manufacturing fees for full-scale
production of pharmaceuticals.
CritiTech's management team also expects
to obtain revenue from license fees and royalty agreements
resulting from the reformulation of products currently on
the market subject to patent expiration in the short term.
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