Coupling of Supercritical CO2 Extraction Processes for the Generation of Solid Self-Emulsifying Drug Delivery Systems (S-SEDDS)
Description
The future of healthcare is being reshaped by innovative drug delivery technologies that aim to overcome the medical barriers and boost treatment efficiency.The development of innovative drug delivery systems is currently a major scientific focus to address the poor bioavailability of poorly water-soluble drugs. Self-emulsifying drug delivery systems (SEDDS) have gained considerable attention for their ability to spontaneously form oil-in-water emulsions in an aqueous media [1], improving drug solubility and absorption. Usually formulated as liquids in soft or hard gelatin capsules, manufacturing [2,3] is limited by production cost, complexity and stability [2].
To overcome these limitations, solid SEDDS (S-SEDDS) can offer the advantages of liquid SEDDS combined to those of solid forms such as, improved physicochemical stability and easier handling [3]. At present, spray drying, freeze drying, hot melt extrusion and a variety nanoparticles technology have been used for S-SEDDS preparation [2,4,5], but these often yield poorly, are energy intensive, and require large amounts of surfactants or organic solvents, limiting industrial use. This research project proposes an innovative and environmentally friendly alternative process using Coupled Carbon Dioxide Supercritical Fluid (CO₂-SC) technology for S-SEDDS production. Two different processes will be combined: Rapid Expansion of Supercritical Solution (RESS) process for lipids crystallization and Supercritical CO2 as anti-Solvent (SAS) process for drug crystallization. The model drug selected is Nifedipine (NIF) with poor water solubility [6]. A coupled CO2-SC-RESS-SAS process could therefore be developed to allow the simultaneous co-crystallization of different self-emulsifying compounds in an only one step.
The project objectives: (i) design and development of a new coupled CO2-SC-RESS-SAS for NIF S-SEDDS, (ii) physicochemical and biopharmaceutical characterization through experimental and In silico modeling (computer aid drug design), (iii) evaluation of intestinal permeation and cytotoxicity using 2D and advanced 3D cell-culture models. The expected outcome is a robust, environmentally friendly, and scalable S-SEDDS manufacturing process supported by an advanced comprehensive characterization platform. This project will also establish a first collaborative research between IMT Mines Albi and the Leibniz University of Hannover on the theme of cell-based formulation evaluation.
Future perspectives include industrial-scale implementation, application to other drug models and to contribute to innovation and sustainability in the pharmaceutical industry by reducing manufacturing environmental impact and improving human health.
Bibliography
Bibliography
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