Versatility on demand – The case for semi-solid micro-extrusion in pharmaceutics

After additive manufacturing of pharmaceuticals has been introduced as viable method to produce individualized drug delivery systems with complex geometries and release profiles, semi-solid micro-extrusion has shown to be uniquely beneficial. Easy incorporation of actives, room-temperature processability and avoidance of cross-contamination by using disposables are some of the advantages that led many researchers to focus their work on this technology in the last few years. First acceptability and in-vivo studies have brought it closer towards implementation in decentralized settings.

Highlights

• Micro-extrusion enables low-temperature processing and easy incorporation of drugs.
• Little danger of cross contamination, wide variety of usable excipients.
• Use of process models as tools for systematic development for optimal printability.
• Lack of regulatory framework and little consensus on CQAs are challenging.

This review covers recently established process models in light of viscosity and printability discussions to help develop high quality printed medicines. Quality defining formulation and process parameters to characterize the various developed dosage forms are presented before critically discussing the role of semi-solid micro-extrusion in the future of personalized drug delivery systems. Remaining challenges regarding regulatory guidance and quality assurance that pose the last hurdle for large scale and commercial manufacturing are addressed. More on Versatility on demand – The case for semi-solid micro-extrusion in pharmaceutics