Hydrogel structures are very useful for tissue engineering. Alginate hydrogels in particular, are of interest because of their unique properties, and high degree of biocompatibility. As alginate gels are formed very rapidly in the presence of gelling ions like Ca2+, alternative formulations are necessary to control gelling time, to create larger constructs and control shape.
NovaMatrix has accomplished this by using internal gelling systems that allow the gelling ion source to be mixed with the alginate solution but released gradually, - before the gel sets. Other currently available gelling systems have limitations because of their low biocompatibility (due to pH changes), the involvement of other undesirable constituents, and/or sub optimal gelling properties.
Self-gelling alginate formulations developed by NovaMatrix, are made by mixing a dispersion containing insoluble calcium (or other gelling ion) alginate particles, with sodium alginate solutions. Mixing can be easily performed, by repeatedly passing the solutions between two connected syringes. This initiates a rearrangement of gelling ions between insoluble and soluble alginate molecules resulting in gel formation. The setting of the gel typically reaches most of its stability within about one hour after mixing. The gelling process may be modulated through the variation of several parameters such as the alginate purity, particle size, concentration of alginates and gelling and non-gelling ions, and the use of sequestrating agents. Cells, API’s, or other components may also easily be entrapped into the gel system, ready for injection in-situ. Gelling time may be delayed appropriately (up to a few minutes) so that the formulation may be molded or injected as desired before the gel is set. Development of gel strength with time can also be easily characterized.
The high degree of formulation flexibility of alginate self-gels can be utilized to meet your specific requirements. For example the gelling time, gel strength, stability, and degradation rate can all be modified. These alginate self-gelling-systems may find use in several biomedical areas: Implantation as a space filling material, coating of medical devices, delivery of active substances, cell entrapment, wound healing, as well as a myriad of other tissue engineering applications.
Administration of the self-gel system in animals has demonstrated a high degree of biocompatibility as well as a lack of any adverse effects. All components are manufactured according to GMP procedures. A Drug Master File covering these products has been submitted to the US FDA.
NovaMatrix is capable of adapting the gel-system for specific application requirements. This technology is available for license from NovaMatrix.
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