SUpersaturation and Phase-separation Research on Drug Absorption: Mechanistic Evaluation in Pharmaceutical Development

Descripción del proyecto

Reducir los ensayos con animales con formulaciones farmacéuticas sobresaturantes

Muchos fármacos prometedores fracasan debido a su baja solubilidad y absorción en el organismo. Las formulaciones sobresaturantes, que aumentan la biodisponibilidad de fármacos poco solubles en agua mediante la generación de soluciones estables de alta concentración en el intestino, son una solución prometedora. Predecir su eficacia en pacientes sigue siendo difícil y, por ahora, exige recurrir a ensayos con animales y a costosos procesos de prueba y error. En el proyecto SUPRA-MED, financiado por las acciones Marie Skłodowska-Curie, se desarrollará una herramienta validada de apoyo a la toma de decisiones para seleccionar los mejores métodos «in vitro» para evaluar formulaciones sobresaturantes. El proyecto combinará caracterización fisicoquímica avanzada, modelos de laboratorio y técnicas espectroscópicas de vanguardia. Los resultados podrían acelerar el desarrollo de fármacos y reducir los ensayos con animales.

Objetivo

The central scientific objective of this project is to establish a mechanistic framework for predicting oral drug absorption from supersaturating formulations by developing a decision tree for rational in vitro method selection and validating robust in vitro–in vivo relationships. This approach will minimise reliance on animal studies, reduce the number of costly and time-consuming experimental iterations required during formulation optimisation, and ultimately accelerate the pathway from discovery to patient access.

Supersaturating formulations will be extensively characterised using a suite of advanced physicochemical and in vitro tools, ranging from dissolution–permeation assays with artificial barriers to physiologically relevant intestinal organoid cultures. Techniques including Dynamic Light Scattering, Polarised Light Microscopy, Fluorescence and Raman spectroscopy, and Broadband Acoustic Resonance Dissolution Spectroscopy will enable detailed characterisation of drug-rich colloidal species and their interactions with the intestinal epithelium. The outcome will be a decision tree guiding the rational selection of in vitro methods for evaluating supersaturating formulations, supported by mechanistic insights into LLPS and nano-crystal-mediated absorption. The developed methodologies & decision tree will be validated to TRL Level 6 during the industrial secondment.

The fellowship will be carried out in an intersectoral environment, bringing together leading academic and industrial partners with extensive experience in training, innovation, and translational science. The fellow will gain expertise in advanced in vitro methodologies, while also acquiring transferable skills in scientific writing, communication, and leadership. Secondments in the pharmaceutical industry will provide first-hand experience of product development pathways, IP management, and regulatory strategy, positioning the fellow for a future career at the interface of academia and industry.