The importance of pre-formulation studies and of 3D-printed nasal casts in the success of a pharmaceutical product intended for nose-to-brain delivery

• Published in: Advanced drug delivery reviews Vol. 175; p. 113826
• Main Authors: Deruyver, Laura, Rigaut, Clément, Lambert, Pierre, Haut, Benoît, Goole, Jonathan
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.08.2021
• Subjects: 3D printing; Administration devices; Administration, Intranasal - methods; Animals; Brain - drug effects; Brain Diseases - drug therapy; Drug Compounding - methods; Formulation properties; Humans; Nasal casts; Nasal Cavity - anatomy & histology; Nose-to-brain; Olfactory region; Pre-formulation studies; Printing, Three-Dimensional; Treatment effectiveness; Nasal casts; Formulation properties; Treatment effectiveness; Administration devices; Pre-formulation studies; Olfactory region; Nose-to-brain; 3D printing
• ISSN: 0169-409X; 1872-8294; 1872-8294
• DOI: 10.1016/j.addr.2021.113826

[Display omitted] •A framework to develop nose-to-brain drugs combining pharmaceutics and engineering.•The importance of the pre-formulation for safe, stable and efficient formulation.•The selection of the administration device to target the olfactory zone.•The 3D-printing of nasal casts to check the suitability of formulation properties. This review aims to cement three hot topics in drug delivery: (a) the pre-formulation of new products intended for nose-to-brain delivery; (b) the development of nasal casts for studying the efficacy of potential new nose-to-brain delivery systems at the early of their development (pre-formulation); (c) the use of 3D printing based on a wide variety of materials (transparent, biocompatible, flexible) providing an unprecedented fabrication tool towards personalized medicine by printing nasal cast on-demand based on CT scans of patients. This review intends to show the links between these three subjects. Indeed, the pathway selected to administrate the drug to the brain not only influence the formulation strategies to implement but also the design of the cast, to get the most convincing measures from it. Moreover, the design of the cast himself influences the choice of the 3D-printing technology, which, in its turn, bring more constraints to the nasal replica design. Consequently, the formulation of the drug, the cast preparation and its realisation should be thought of as a whole and not separately.