Abstract

Fused filament fabrication (FFF) is a process used to manufacture oral forms adapted to the needs of patients. Polyethylene oxide (PEO) filaments were produced by hot melt extrusion (HME) to obtain a filament suitable for the production of amiodarone hydrochloride oral forms by FFF 3D printing. In order to produce personalized oral forms adapted to the patient characteristics, filaments used by FFF must be controlled in terms of mass homogeneity along filament. This work highlights the relation between filament mass homogeneity and its diameter. This is why the impact of filler excipients physical properties was studied. It has been showed that the particle’s size distribution of the filler can modify the filament diameter variability which has had an impact on the mass of oral forms produced by FFF. Through this work it was shown that D-Sorbitol from Carlo Erba allows to obtain a diameter variability of less than 2% due to its unique particle’s size distribution. Using the filament produced by HME and an innovating calibration method based on the filament length, it has been possible to carry out three dosages of 125 mg, 750 mg and 1000 mg by 3D printing with acceptable mass uniformity.

Highlights

  • One of the great challenges of the 21st century in the pharmaceutical field is to offer drugs with a dosage adapted to the physiological needs of each patient

  • Three-dimensional printing technology can adjust the amount of active pharmaceutical ingredient (API) in oral forms as needed

  • The results showed that the variability in filament diameter impacted the mass variability of the printed oral forms

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Summary

Introduction

One of the great challenges of the 21st century in the pharmaceutical field is to offer drugs with a dosage adapted to the physiological needs of each patient. The modification of the metabolism in the elderly can modify the absorption of the active ingredient while in children, the variation in weight between individuals is such that the need for the active ingredient can vary by a factor of 20 [3] This context highlights the need to adapt the dose of active ingredient according to the patient’s characteristics. Three-dimensional printing technology can adjust the amount of active pharmaceutical ingredient (API) in oral forms as needed. This would make it possible to reach a milestone in the field of personalized medicine

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