title: Three-Dimensional Printing of Medicinal Products and the Challenge of Personalized Therapy.
abstract: By 3-dimensional (3D) printing, solid objects of any shape are fabricated through layer-by-layer addition of materials based on a digital model. At present, such a technique is broadly exploited in many industrial fields because of major advantages in terms of reduced times and costs of development and production. In the biomedical and pharmaceutical domains, the interest in 3D printing is growing in step with the needs of personalized medicine. Printed scaffolds and prostheses have partly replaced medical devices produced by more established techniques, and more recently, 3D printing has been proposed for the manufacturing of drug products. Notably, the availability of patient-tailored pharmaceuticals would be of utmost importance for children, elderly subjects, poor and high metabolizers, and individuals undergoing multiple drug treatments. 3D printing encompasses a range of differing techniques, each involving advantages and open issues. Particularly, solidification of powder, extrusion, and stereolithography have been applied to the manufacturing of drug products. The main challenge to their exploitation for personalized pharmacologic therapy is likely to be related to the regulatory issues involved and to implementation of production models that may allow to efficiently turn the therapeutic needs of individual patients into small batches of appropriate drug products meeting preset quality requirements.
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Sezione di Tecnologia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71, Milan 20133, Italy. Electronic address: lucia.zema@unimi.it.
authors.forename: Lucia
authors.initials: L
authors.lastname: Zema
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Sezione di Tecnologia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71, Milan 20133, Italy.
authors.forename: Alice
authors.initials: A
authors.lastname: Melocchi
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Sezione di Tecnologia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71, Milan 20133, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Maroni
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Sezione di Tecnologia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71, Milan 20133, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Gazzaniga
mesh_terms: D003692:Delayed-Action Preparations / Q000737:chemistry; D004339:Drug Compounding / Q000295:instrumentation* / Q000379:methods; D016503:Drug Delivery Systems; D004867:Equipment Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry; D011208:Powders; D057285:Precision Medicine / Q000295:instrumentation / Q000379:methods; D066330:Printing, Three-Dimensional
chemical_list: D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D011208:Powders
keywords: 3D printing; controlled release; drug delivery systems; extrusion; fused deposition modeling; oral drug delivery; personalized medicine; solid dosage form; solidification of powder; stereolithography