PROJECT IMPLEMENTATION PLAN
3 rd Stage/2024
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Year 2024 - Reporting period 01.01.2024 – 30.06.2024
Stage 3 - Laboratory implementation of optimized nanostructured nutraceutical formulations conditioned as oral pharmaceutical forms with synergistic bioactivities by demonstrating in vitro functionality.
Verifiable estimated results of the stage:
- formulations of nanostructured nutraceutical products packaged as orodispersible tablets, controlled-release tablets and lyophilized powders for oral use
- 1 scientific article in ISI journal (WoS)
- 1 communication at international conferences
- 2 patent applications submitted to OSIM
Act 3.1 - Elaboration of technical documentation in order to realize the implementation of functional models of nanostructured nutraceutical formulations conditioned as orodispersible tablets, tablets with controlled release and lyophilized powders for oral use, selected following the evaluation of biological activity and phytotoxicological and cytotoxicological analyzes.
Act 3.2 - Experimentation and verification of prototypes of nanostructured nutraceuticals conditioned in the form of orodispersible tablets, controlled-release tablets and lyophilized powders for oral use.
Act 3.3 - Widely dissemination of results through international conference communications, publication of a scientific article in ISI journal (WoS). Updating the project web page.
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SUMMARY OF STAGE III / 2024
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Project name: INNOVATIVE NANOSTRUCTURED NUTRACEUTICS WITH SYNERGIC BIOACTIVITIES FOR HEPATO-DIGESTIVE PROTECTION (NUTRASINPRO)
The aim of this stage of the project was the achievement of the technical documentation as well as the verification of nanostructured nutraceutical prototypes as effective and safe formulations with potential hepato-digestive protection by packaging in the form of orodispersible tablets, extended-release tablets and bioactive dispersible powders for oral use of some fluid extracts from bitter cherry, blue honeysuckle fruits, red grape pomace, with and without the association of extracts from green barley germ with prebiotic effect, encapsulated in a nanostructured matrix of mesoporous hybrid mass of silica MCM-41, associated or not with a mixture of Lactobacillus sp. with probiotic effect. The main objectives O7 and O8 of phase 3/2024 of the project have been achieved in accordance with the project realization plan. Thus, the final optimized variants of the hybrid mesoporous silica hybrid nanomatrix loaded with the selected mixtures of fluid fruit extracts (MFE) of bitter cherry, blue honeysuckle, red grape pomace and green barley sprouts were obtained and the loading was physicochemical evaluated by UV-Vis-NIR, FT/IR, SEM analyses. Based on the mesoporous hybrid silica nanomatrix loaded with the selected variants of mixtures of fluid fruit extracts (MFE), nanostructured nutraceutical formulations were realized, by associating or not, with a mixture of Lactobacillus sp. lyophilized powder, for a probiotic effect, the technical documentation for the experimentation and verification of the selected variants of nanostructured nutraceutical formulations made in the laboratory, their characterization in terms of physico-chemical properties and their conditioning in the form of orodispersible tablets, extended-release tablets and bioactive dispersible powders for oral use. Antimicrobial activity on Gram-positive and Gram-negative pathogenic strains was tested and demonstrated. The hepatoprotective and gastrointestinal capacity of novel nanostructured nutraceutical formulations with different compositions has been verified and demonstrated on in vitro experimental models, nano-encapsulated in hybrid mesoporous silica nanomatrix loaded with a mixture of fluid fruit extracts (MFE) and green barley germ as prebiotic, combined with a mixture of lactic acid bacterial strains for a probiotic effect, packaged as sustained-release tablets and bioactive dispersible lyophilized freeze-dried powders. The biological potential and usefulness of the realized nutraceutical formulations in the development of new natural products with hepato-digestive protective properties has been demonstrated by in vitro biomimetic modeling. Biological tests performed on different in vitro experimental models allowed comparative studies to verify the liver-protective effect of nanostructured nutraceutical formulations by determining the biocompatibility and lipid particle accumulation in cultures of human HepG2 hepatocytes stressed with a mixture of fatty acids, confirming the in vitro simulated hepatic steatosis modulating property. Verification and demonstration of the capacity of nutraceutical formulations for gastrointestinal protection in HT29 intestinal epithelial cell cultures co-cultured with lactobacilli, confirming the prebiotic effect of the products. The ability of the nutraceutical formulations to maintain viability and probiotic effect after conditioning and storage was verified and demonstrated. Statistical data analysis was performed and optimal functional prototypes were selected. The final conditioned nanostructured nutraceutical formulations for oral use were developed.
In conclusion, in the 3rd phase of the project, all the result indicators were achieved, and the value of the obtained results is supported by the dissemination of the original results, through the publication of a scientific article in a quoted ISI (WoS) journal with high visibility (red zone, Q1), participation with 4 scientific papers in international, national conferences and round tables. 2 Patent applications were registered with OSIM. The project web page was updated at https://univovidius.wixsite.com/nutrasinpro. Data obtained in the project partnership have been centralized and integrated by the project coordinator in the Phase 3/2024 RST and Final RST.
The general objective of the project is the development of gentle, innovative technologies for the production of innovative, effective and safe nanostructured systems of controlled release obtained from fluid extracts of bitter cherry, blue honeysuckle and gooseberry fruits nanoencapsulated in mesoporous silica-prebiotic hybrid nanomatrices from germs of barley enriched with probiotic strains of Lactobacillus sp.
EXECUTION STAGE no. 3 – Laboratory implementation of optimized nanostructured nutraceutical formulations conditioned as oral pharmaceutical forms with synergistic bioactivities by demonstrating in vitro functionality
EXECUTION PERIOD: 01 January – 30 June 2024
OBJECTIVES OF THE EXECUTION STAGE no. 3/2024
O8. Development of technical documentation for obtaining nanostructured nutraceuticals at laboratory scale and selection of optimal excipients for nanostructured nutraceutical formulations conditioned as orodispersible tablets (tablets), controlled release tablets (tablets) and lyophilized powders for oral use.
O9. Establishing the specific quality and stability conditions by compendial and non-compendial methods according to Ph.E.9.0 and Ph. Ro. Ed. 10.0.
O10. Development of final formulations of conditioned nanostructured nutraceuticals in the form of orodispersible tablets (tablets), controlled release tablets (tablets) and lyophilized powders for oral use.
O11. Demonstration of in vitro functionality of nanostructured nutraceuticals for intestinal and hepatoprotective effect using in vitro cell culture models on fibroblast and hepatocyte cell lines
O12. Dissemination of scientific results and project management.
DELIVERIES MADE:
• Formulations of optimized nanostructured nutraceutical products conditioned with orodispersible tablets (tablets), controlled release tablets (tablets) and lyophilized powders for oral use.
• Communications at scientific events
• Scientific article published in ISI journal (WoS)
• Invention patents submitted to OSIM
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