Dose Titration of Solid Dosage Forms via FDM 3D-Printed Mini-Tablets

Guluzar Gorkem Buyukgoz, Christopher G. Kossor, Shen Ji, Murat Guvendiren, Rajesh N. Davé

Research output: Contribution to journalArticlepeer-review

Abstract

The robustness of 3D-printed mini-tablets as a platform to administer milligram dosages, intended for age-specific therapy, without the need of tablet splitting while maintaining similar release profiles, was investigated. Griseofulvin, as a model poorly water-soluble drug, and hydroxypropyl cellulose along with Kollicoat Protect as polymers were used to prepare filaments at 1–20% drug concentrations via hot-melt extrusion (HME). Higher drug concentrations served for testing the feasibility of a reduced number of mini-tablets to be administered. A reliable dose titration in the range 0.19–3.91 mg at a high accuracy (R2 of 0.999) was achieved through composite unit (multi-unit) mini-tablets. All mini-tablets produced had excellent content uniformity and their label claim values were within the acceptable range, proving that HME processing followed by 3D printing promotes content uniformity even for mini-tablets containing low drug doses (0.19 mg). Remarkably, the proposed approach allowed achieving similar drug release profiles via composite unit mini-tablets as well as single mini-tablets at high drug concentrations. In contrast, split tablets demonstrated different release behaviors, attributed to their size and shape differences. Overall, the distinct advantages of mini-tablets to provide dose flexibility while maintaining similar release profiles was demonstrated.

Original languageEnglish (US)
Article number2305
JournalPharmaceutics
Volume14
Issue number11
DOIs
StatePublished - Nov 2022

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

Keywords

  • FDM 3D-printing
  • high and low drug concentrations
  • low-dose titration
  • mini-tablets
  • personalized medicine
  • split tablets

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