Unprocessed

Processed

Size Distribution of Processed and Unprocessed Acetominophen
(Dry Powder Analysis, Number Difference)

2 - Nanoparticulate Paclitaxel Mice Study:

It is estimated by the American Cancer Society that over 1.26 million new cancer cases will be diagnosed in 2001 in the US.  Cancer is generally treated with surgery, radiation, chemotherapy or a combination of treatments.  In chemotherapy there are seven different classes of anti-cancer drugs currently approved in the US that have their genesis in natural compounds. In 1999, the global sales of paclitaxel constituted 22% of all major cytotoxic compounds used in chemotherapy. Paclitaxel Worldwide sales are estimated to exceed 2 Billion dollars. Moreover, this taxane is the largest selling cytotoxic agent in the world despite its major solubility problems, carrying agent and toxic effect.

CritiTech believes it can achieve similar results with “nanopaclitaxel” without the toxic effects of the Cremophor® carrying agent used in the standard drug formulation. In an experiment carried out in conjunction with Dr. Katherine Roby from the Kansas University Medical Center, CritiTech has been able to effectively extend the life of mice with cancer that were treated with nanoparticulate Paclitaxel versus those treated with Paclitaxel formulated with Cremaphore© -the current standard formulation. For intraperitoneal (IP) dosage, nanopaclitaxel treated mice survived -on average- about 180 days after tumor induction as compared to regular paclitaxel treated animals that only survived to about 105 days. Control animals survived only 87 days. For intravenous (IV) dosage, nanopaclitaxel and regular paclitaxel treated mice showed identical survival rates. Therefore, the data suggests that nanopaclitaxel could provide additional effectiveness and safety. Because of CritiTech’s ability to harvest in quantity, the nanoparticulate paclitaxel may also prove to be more cost effective.

CritiTech had a successful pre-IND meeting with the FDA in late 2005 on Nanotax®, its proprietary formulation of pacitaxel and will be initiating Phase I trials with Nanotax® during 2006. The pilot scale GMP production crystallizer unit has been installed in Aptuit (formerly Quintiles) GMP production facility. The trials are to be held at the University of Kansas Medical Center in Kansas City.

Nanotax Product Profile

As of October 16, 2001, CritiTech has a U.S. Provisional Patent Application for the “COMPOSITON AND METHODS FOR DELIVERY OF POORLY WATER SOLUBLE DRUGS AND METHODS OF TREATMENT”
 

3- Insulin Studies:
CritiTech has successfully used PCA to precipitate biosynthetic human insulin from solution in a halogenated alcohol, using supercritical CO2 as antisolvent. Supercritical fluid processing of insulin from solution in HFIP, followed by de-agglomeration, is a viable means of producing microparticles suitable for pulmonary inhalation therapy.  Particles of insulin with narrow size distributions and means in the 1–5 mm size range (suitable for pulmonary inhalation therapy) were obtained without seriously degrading the insulin or reducing the potency of the insulin.

4- Coating of Medical Devices and Substrates:
Using its patented supercritical fluid-based coating technology, CritiTech, Inc., has succeeded in coating expanded cardiac stents with ethylcellulose containing yellow Opaspray to facilitate viewing of the coated stent. Polymer, dissolved in suitable organic solvent, is sprayed into the near critical carbon dioxide in close proximity to the fluidized stents.  Thickness of coating can be controlled by duration of spraying.  Texture can be controlled by alteration of temperature above and below the glass transition temperature of the polymer used.  A model drug has been substituted for the dye to create a timed-release drug delivery device. This stent coating procedure is an extension of CritiTech’s patented technology that is used for coating water-soluble substrates with organic-soluble coating materials.  CritiTech can also coat substrates in the size range from 300 microns to 1/4-inch tablets uniformly, rapidly and in bulk.