Phase 1:
Study design of IMA-HEALTH and preliminary results
Summary
Review of existing technical documentation, industrial research, pursues the review of existing documentation and bioavailability of food supplements to choose the optimal solutions for preparation methods of IMA-HEALTH materials (TRL4).
Considerations for bioavailability of dietary supplements. It will accomplish a documentary study regarding intake and bioavailability of nutrients of interest, matrix and host factors, influence on the bioavailability of dietary supplements, risk-benefit-implications assessment of dietary supplements based on hydroxyapatite.
Detailed design of in vitro experiments for testing
innovative materials - first part. Adaptation of testing methods to
physical and pharmaceutical formulation of material, establishing the acute/subacute/chronic
classs of testing design, setting seriate concentration domain considering
the already existing literature data as well as corsortia experience
regarding the inner theoretical biocompatibility of innovative material are
going to be considered.
Phase 2:
Realization of IMA-HEALTH materials at TRL3 level
Summary
*Development of synthetic sub-micron hydroxyapatite and complex with D3 and K2 vitamin materials. It will be developed 2 preparation methods for pure HAP and HAP/vitamin.
*Experimentation and physico-chemical characterization of IMA-HEALTH materials. Release profile of active ingredients. A series of experiments will be performed for the physical-chemical characterization of the IMA-HEALTH products, using advanced methods for structural characterization.
*Detailed design of in vitro experiments for testing innovative materials - final part. Dynamic in vitro platforms, as well as different tridimensional and co-culturing systems options are going to be analyzed and the optimal system is going to be selected according to the material property.
*Analysis and interpretation of obtained results for optimization. The results obtained will be analyzed. The results will form the basis for optimized IMA-HEALTH materials at TRL3 level.
*In vitro testing of newly designed construct on osteoblast cell line. Therapeutic effect on osteoporosis will be tested using MC3T3-E1 osteoblastic cell line.
*Optimization of IMA-HEALTH EM. Characterization of optimized IMA-HEALTH EM. Verification of IMA-HEALTH materials. Based on the obtained results, the materials with appropriate characteristics to the goal of project will be chosen for optimization, incorporation in dietary supplements and potential marketing.
*In vitro testing of synthesis drug on human endothelium. HUVEC cell line is going to be used as cellular model for understanding effects following endothelium exposure to HAP or ms-HAP, and their complexes with vitamin D3 and vitamin K2.
Phase 3:
Validation at lab scale of IMA-HEALTH EM (TRL4)
Summary
*Analysis, interpretation and corroboration of the obtained results. The corroborated results form the basis for IMA-HEALTH materials at TRL4 level.
*Validation at lab scale of optimized IMA-HEALTH EM ingredients. Based on the obtained results IMA-HEALTH EM preparation methods/materials have been validated at lab scale: preparation method for pure HAP; preparation method for HAP/vitamin complexes. HAP/D3, HAP/K2, HAP/D3/K2.
*Demonstrating the utility and functionality of IMA-HEALTH EM. Demonstrative session was organized in order to demonstrate the utility and functionality of IMA-HEALTH preparation methods/materials.
*Valorification possibility of IMA-HEALTH materials. Partners demonstrated that IMA-HEALTH materials meet the criteria of European regulations on nutraceuticals, dietary supplements and functional foods.
· Obtained Results:
The project aimed to validate at the laboratory scale, TRL4, new materials based on hydroxyapatite (HAP: pure and multi substituted) as well as their complex with materials with vitamins D3 and K2 as food supplements to support the correct deposition of calcium in the bone matrix, as well as the preventions of pathologies related to aging associated with alterations and dysfunctions of endothelial cells (cardiovascular diseases, neuro-cognitive degenerative disorders or metabolic dysfunctions). Pure and multi-substituted HAP is a very efficient source of Ca, P and essential physiological elements and in combination with vitamins D3 and K2 contributes to maintaining the body”s health.
*A complex study was carried out regarding food supplements based on vitamin D3 and/or vitamin K2, regarding bioavailability, the role and importance of minerals and vitamins in the body. An exhaustive analysis of the national and EU legislation regarding food supplements of interest was also carried out.
*The hydroxyapatites were obtained by synthesis, filtration and drying by Freeze Dryer (Fig.1). The obtained IMA-HEALTH materials were characterized by physico-chemical methods: Fourier Transform Infrared Spectroscopy, X-Ray Diffraction, Electron Microscopy, Atomic Force Microscope (Fig 2). The release profil of active substances from IMA-HEALTH materials in biological environments (saliva, gastric fluid, intestinal fluid) was studied.
*Project results: validation in laboratory conditions of 2 preparation methods and 8 advanced IMA-HEALTH materials: simple hydroxyapatite (HAP) or HAP with vitamins (HAP/D3, HAP/K2, HAP/D3/K2 ), and multi-substituted hydroxyapatite (ms-HAP) or ms-HAP with vitamins (ms-HAP/D3, ms-HAP/K2, ms-HAP/D3/K2) specially designed to replace imported food supplements.
*Corroborating the informations obtained in the project, it can be stated that the IMA-HEALTH materials meet the requirement of materials for food supplements and it is recommended to transfer them to an interested SME for their development and introduction into manufacturing as food supplements, either as an individual or integrated product in a complex with other components of interest.
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Fig. 1. Freeze Dryer
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Fig. 2. Atomic Force Microscope
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