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.