Advanced manufacturing of drug substances by co-processing with excipients through heteronucleation in a milifluidic device

Descripción del proyecto

Revolucionar la fabricación farmacéutica continua

En la industria farmacéutica se experimenta una demanda creciente y se prevén periodos de aumentos caóticos debido a las enfermedades y pandemias que se producen por el cambio climático. A pesar de los esfuerzos por promover la fabricación continua, que promete una producción de fármacos más barata, sostenible, adaptable y rápida, las propiedades mecánicas deficientes de muchas sustancias las hacen inadecuadas para este proceso. El equipo del proyecto ManCoProc, financiado por las Acciones Marie Skłodowska-Curie (MSCA), pretende abordar este reto mediante el desarrollo de una plataforma universal de coprocesamiento de fármacos y excipientes que aproveche las técnicas de cristalización y coprecipitación para superar las limitaciones que plantean las propiedades mecánicas deficientes de muchos fármacos. En el proyecto se utilizarán tecnología y técnicas de vanguardia para analizar y optimizar este proceso innovador.

Objetivo

Pharmaceutical industry is starting to adopt the approach of continuous manufacturing, with as few unit operations as possible, to deliver drug products in a faster, robust, cheaper and sustainable way.
Poor mechanical properties of many drug substances are a hindrance to this, making them unsuitable for direct compression into tablets without additional operations. This challenge can be solved by co-processing: joining the particles of such drugs to the particles of inactive substances known as excipients (e.g. lactose), normally used for tablets production.
The aim of this project is to develop a universal drug-excipient co-processing (CP) platform based on surface crystallization or co-precipitation. A CP method in a milifluidic device will be optimised with a range of drugs with differing physicochemical properties. The relationships between them, as well as excipient properties, parameters of the method and structural and functional characteristics of the obtained composites will be thoroughly investigated. To this end, cutting edge techniques will be employed to analyse particle size, morphology, dissolution and mechanical behaviour. To demonstrate improved manufacturability, the prototype CP material will be used for direct compression, and the tablets quality will be evaluated according to European Pharmacopeia requirements.
The project will enable the researcher to achieve professional maturity in the field of particle engineering, allowing to employ her skills both in academia and in pharmaceutical industry. The results of the research will have commercialisation value, being of interest to companies as a potential new platform in (pre)formulation portfolio. The project will contribute to the body of evidence informing the decisions of regulators on pharmaceutical co-processing. In the long term, such impact should advance the transformation towards continuous manufacturing of affordable, available and sustainable drug products.