Matrix III Competitive Advantages

Matrix III is unique among the relatively few resorbable dimensionally stable materials on the market.

The microenvironment as seen by the drug or antigen entrapped in Matrix III is hydrophilic or polar, as opposed to hydrophobic. Drug delivery systems based on water-insoluble polymers, such as polylactic acid, provide a hydrophobic microenvironment. For protein drugs this can be problematic as most proteins demature as hydrocarbon-water interfaces.

Matrix III is resorbable (biodegradable). The resorption mechanism is dissolution. For synthetic polymers the resorption process is normally hydrolysis, which is accompanied by acid production, which in turn can inhibit healing.

Control of the release profile and erosion rate is an advantage of Matrix III. Matrix III Beads (3mm) implanted under the skin have a residence time of 5-6 weeks. The residence time can be modulated by inclusion of various additives, and by variation of the solid-to-liquid ratio in the formulation.

Unlike collagen and other proteinaceous drug delivery matrices, Matrix III is refractory to the action of hydrolytic enzymes. Matrix III can be installed at inflamed sites or directly into tumors without the risk of premature degradation by hydrolytic enzymes. This feature enhances Royer Biomedical, Inc.'s ability to deliver antibiotics and anti-tumor agents directly to the site of infection or malignancy.

The simple and economical manufacturing processes of Matrix III formulations are attractive, especially for high volume products. Terminal sterilization with gamma irradiation is feasible. No organic solvents are used in the manufacture of Matrix III dosage forms.

Matrix III has physical characteristics that distinguish it from other resorbable matrices. It is dimensionally stable and can be made to have a wide range of porosities, without a deleterious effect on the release profile, dimensional stability, or erosion rate. Compressive strength exceeds 2,000 PSI. These traits are ideal for matrices used in the orthopedic and periodontal areas. Vaccines based on pneumatic injection systems would also benefit by formulation in Matrix III. A dimensionally stable "micro-bullet" would be easy to manufacture and mechanically well suited for gas powered inoculation systems.