Application of 3D printing in early phase development of pharmaceutical solid dosage forms

Rachel L. Milliken, Thomas Quinten, Sune K. Andersen, Dimitrios A. Lamprou*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

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Abstract

Three-dimensional printing (3DP) is an emerging technology, offering the possibility for the development of dose-customized, effective, and safe solid oral dosage forms (SODFs). Although 3DP has great potential, it does come with certain limitations, and the traditional drug manufacturing platforms remain the industry standard. The consensus appears to be that 3DP technology is expected to benefit personalized medicine the most, but that it is unlikely to replace conventional manufacturing for mass production. The 3DP method, on the other hand, could prove well-suited for producing small batches as an adaptive manufacturing technique for enabling adaptive clinical trial design for early clinical studies. The purpose of this review is to discuss recent advancements in 3DP technologies for SODFs and to focus on the applications for SODFs in the early clinical development stages, including a discussion of current regulatory challenges and quality controls.

Original languageEnglish
Article number123902
Number of pages21
JournalInternational Journal of Pharmaceutics
Volume653
Early online date16 Feb 2024
DOIs
Publication statusPublished - 25 Mar 2024

Keywords

  • 3D Printing
  • Solid oral dosage forms
  • Pharmaceutical
  • Rapid prototyping
  • Preclinical
  • Additive manufacturing

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