The product was developed and patented in the Chair and Department of Biochemistry and Biotechnology, Faculty of Pharmacy with Medical Analytics Division, Medical University of Lublin, based on synthetic hydroxyapatite granules (developed in Department of Ceramics and Refractory Materials, AGH University of Science and Technology in Cracow) and natural organic polymer. This is a non-toxic, biocompatible, micro- and macroporous composite, of porosity imitating that of natural bone tissue, which may serve as an excellent scaffold for cells migration and formation of natural bone tissue in vivo.
The composite prepared according to the invention, compared with the calcium phosphate granules without polymer, reaches a much better biological and mechanical parameters, thus becoming the next-generation implant material for treatment of bone defects. In the wet state it becomes flexible, susceptible to bending and compression, allowing it to fit the dimensions of the cavity being completed. The material can be cut to the desired shape using a knife or scalpel. In the dry state (24 hours at 40oC), it is not susceptible to fungal contamination, and therefore can be stored for at least 12 months without changing its properties. Dry composite, after soaking in the fluid (water, saline, solutions of drugs or proteins) for several minutes (depending on the size and shape of the sample), absorbs water and regains its resilient properties. After sterilization, it may be further stored. The composite exhibits high surgical handiness and mechanical and biological parameters similar to those of the human bone.
The composite material was subjected to a preliminary clinical trials involving patients of the Animals Surgery Clinic on the Faculty of Veterinary Medicine, University of Life Sciences in Lublin (the agreement of II Local Ethics Committee for the Animal Experiments in Lublin, No. 15/2010). It was used for filling of tooth extraction sockets and oronasal fistulas in dogs. The composite was excellently fixed at the implantation site, causing no inflammatory reactions. Its effectiveness as a bone-substitute material was confirmed by X-ray examination.
The composite has also been tested as a graft material to fill cavities in the tibia of rabbits (the agreement of I Local Ethics Committee for Animal Experiments in Lublin, No. 16/2010; the agreement of the II Local Ethics Committee for Animal Experiments in Lublin, No. 44/2010). The results indicated the biocompatibility of the biomaterial with surrounding bone tissue. Similarly, the histological evaluation confirmed the appearance of ossification at the implant site (visible cells and bone lamellae). The composite influences the bone remodelling, creation of new osteons, it integrates with and is penetrated by the surrounding bone tissue, and stimulates the bone rebuilding process by the formation of an organic matrix (collagen) and mineralization.
PRODUCT’S FORMS (small shapes):
The composite is the potential implantation material for filling the bone tissue defects appearing as a result of mechanical trauma and surgical procedures. It could be used as the filler of bone defects in bone and the facial skeleton area. When introduced into bone defect, it will serve as the scaffolding for osteoblasts, thus providing the osteoconductive properties.