Project: ‘Prototyping a complex multifunctional analytical facility for the biopharmaceutical assessment of hard-to-develop oral medicinal products’, RIS3: 2 biomedicine, medical technology, pharmacy; NACE: M72.19 The main objective of the activities included in the project is to develop a complex multifunctional prototype analytical equipment (system) for biopharmaceutical assessment of hard-to-develop oral medicinal products. This innovative system will be used for the simultaneous investigation of the permeability of medicinal products (or active pharmaceutical ingredients, APIs) through ex vivo and artificial membranes together with compendial excretion and/or dissolution. Artificial digestion, including lipolysis and proteolysis, will be optionally added to this system, allowing the simultaneous study of the effects of artificial digestion on permeability together with compendial drug release/solution. The system will be used in biopharmaceutical studies of oral formulations and will affect a number of topical problems in the development of pharmaceutical drugs, namely: Improvement of the bioavailability of orally administered medicinal products Reduction of financial investments in clinical trials Increasing the level of success and reducing the risks of clinical trials Improvement of pharmacotherapeutic results Reduction of the amount of the substance of medicinal products necessary to achieve therapeutic effect Reduction of the amount of the substance of unabsorbed medicinal products and its impact on the environment Planned category of studies: industrial research Classification by fields of research and development: 2.2.6. (Engineering and Technology, Medical Engineering) Dr. Valentyn Mohylyuk Relationship to economic activity: is not related to economic activity, i.e. all potential profits from the know-how and technology transfer activities carried out within the framework of the project will be invested in the core activities of the research organisation. Control of the development and use of the prototype will be ensured in accordance with the RSU Accounting Procedures, Section 5.1. The procedure for allocating revenue from commercialisation is set out in Paragraph 11 of the RSU Intellectual Property Management Policy. Partner: The Saint-Tech project will achieve scientific results: the development of a complex multifunctional prototype analytical equipment (system) for the biopharmaceutical assessment of hard-to-develop oral medicinal products (TRL level 4) suitable for simultaneous dissolution and permeability testing of BCS Class I, II, III and IV medicinal products, including those requiring artificial digestion; a prototype conforming to the requirements for installation, performance and operational qualification; scientifically sound operational settings; scientifically proven usability of the developed prototype for the stated purpose. The project will achieve technological results: new knowledge (engineering and biopharmaceutical) on the design, construction and commissioning of a complex biopharmaceutical installation; a prototype equipment with a defined range of operating settings has been developed; effective methodology for dissolving-permeability testing of pharmaceuticals to preclinically assess their bioavailability. Within the framework of the project it is planned to: Patent-protected intellectual property rights - ?1 Scientific publications in Q1 journals (SCOPUS/ WoSCC) - ?3 Participation in international scientific conferences - ?3 Total costs: EUR 646,820.65 Duration of the project: 36 months from 1 September 2025. Keywords: drug depletion, dissolution, permeability, ex vivo, artificial digestion, bioavailability, poorly soluble drug