Matrix III
Royer Biomedical, Inc.'s patented Matrix III is an inorganic-biopolymer composite. The inorganic components are mixed with an aqueous biopolymer solution containing the medicinal. The resulting slurry solidifies and entraps the medicinal. The nature and proportions of the inorganic components and polymers determine the release profile and the erosion rate.The Matrix III solid is dimensionally stable and well suited for diverse applications. Administration can be accomplished by: (1) injection of a liquid which solidifies in situ, (2) injections of micro granules (45-150 microns), or (3) direct implantation of large beads (3mm) or cylinders.
The Matrix III delivery system has the following attributes:
- Resorbable
- Safe
- Controllable resorption rate and release profile
- Compatible with a wide range of medicinals, including proteins
- Practical- low cost, easily manufactured, stable, etc.
Royer Biomedical, Inc. has established that the erosion rate in controllable by a third parameter- see US Patent 6,497,901. This proprietary finding enhances Royer Biomedical, Inc.'s ability to program the residence time.
Matrix III provides a hydrophilic microenvironment. The preparation is straight forward and involves no organic solvents. In at least one case, a vaccine based on Matrix III requires no refrigeration or special handling.
Manufacturing on Matrix III under cGMP condition is straight forward and scalable, and has been successfully done with two products (Matrix III can be sterilized by gamma irradiation). Once mixing is complete, the slurry can be transferred to a syringe and delivered into an orthopedic or periodontal defect. To make micro granules (45-150 microns), the slurry is allowed to solidify in bulk. The material is then milled and sized. Large beads and cylinders (both 3mm) are produced in Teflon molds.