Material Considerations for Fused-Filament Fabrication of Solid Dosage Forms.

Evert Fuenmayor,Declan M Devine,Martin Forde,John G Lyons,Andrew V Healy,Christopher Mcconville,Ian Major

doi:10.3390/pharmaceutics10020044

Evert Fuenmayor, Declan M Devine + Show 5 more

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https://doi.org/10.3390/pharmaceutics10020044

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Abstract

Material choice is a fundamental consideration when it comes to designing a solid dosage form. The matrix material will ultimately determine the rate of drug release since the physical properties (solubility, viscosity, and more) of the material control both fluid ingress and disintegration of the dosage form. The bulk properties (powder flow, concentration, and more) of the material should also be considered since these properties will influence the ability of the material to be successfully manufactured. Furthermore, there is a limited number of approved materials for the production of solid dosage forms. The present study details the complications that can arise when adopting pharmaceutical grade polymers for fused-filament fabrication in the production of oral tablets. The paper also presents ways to overcome each issue. Fused-filament fabrication is a hot-melt extrusion-based 3D printing process. The paper describes the problems encountered in fused-filament fabrication with Kollidon® VA64, which is a material that has previously been utilized in direct compression and hot-melt extrusion processes. Formulation and melt-blending strategies were employed to increase the printability of the material. The paper defines for the first time the essential parameter profile required for successful 3D printing and lists several pre-screening tools that should be employed to guide future material formulation for the fused-filament fabrication of solid dosage forms.

Highlights

Three-dimensional printing (3DP) is finding increasing utility in the manufacture of pharmaceutical dosage forms [1]
Caffeine was chosen as a Biopharmaceutical Classification System (BCS) Class I model drug since it was available in sufficient quantities to complete the overall study, has a melting temperature greater than the processing temperatures, and was safe for use in the environments the production equipment were located
We aimed to find a material formulation incorporating PVP-vinyl acetate (VA), which would permit the production of a complete batch (n = 40) of flat-face plain tablets during a single print run

Summary

Introduction

Three-dimensional printing (3DP) is finding increasing utility in the manufacture of pharmaceutical dosage forms [1]. Potential pharmaceutical applications for 3DP are diverse and span conventional dosage forms such as tablets and implants as well as less typical pulsatory devices [3]. Spritam® is the first FDA approved 3D printed dosage form and is an orodispersible tablet containing different doses of the anti-seizure drug levetiracetam [4]. The manufacturers harness 3DP to enable high dosing (1000 mg) while maintaining a highly porous structure that aids rapid disintegration necessary for orodispersibles. Innovation lies at the heart of the drive towards 3D printed dosage forms meant for both the creation of more complex devices and to meet the requirements of on-demand manufacturing and precision medicine [1]

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