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An Effective Technology for the Development of Immediate Release Solid Dosage Forms Containing Low-Dose Drug: Fused Deposition Modeling 3D Printing

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Abstract

Purpose

Fabrication of immediate release (IR) tablet formulations with rapid release profile via fused deposition modeling 3D printing (FDM 3DP) is a challenge. The aims of this study were to prepare IR tablets with different dissolution profiles and to increase their in vitro dissolution rates by making physical modifications on them. Pramipexole was used as the model low-dose drug.

Methods

Polymeric filaments were prepared with six different combinations of Eudragit EPO and poly(ethylene) oxide by hot melt extrusion and 3D tablets were produced using an FDM printer. Characterization studies for the filaments and tablets were carried out. The printability of the filaments was also evaluated using a novel mechanical characterization method. Tablet formulation with optimum dissolution profile was chosen and physical modifications (infill %, shape change and thickness) on this formulation were made.

Results

Low-dose pramipexole loading filaments and 3D tablets were homogenously prepared. The printability of the filaments was related to their flexibility. With the physical modifications, the drug release completion time of the tablets reduced to 5 min.

Conclusions

The same rapid release profiles with conventional IR tablets can be reached by making only physical changes on 3D tablets without using any filling or disintegrating agents.

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Abbreviations

3DP:

3D printing

ABS:

Acrylonitrile butadiene styrene

AM:

Additive manufacturing

API:

Active pharmaceutical ingredient

CAD:

Computer aided design

DSC:

Differential scanning calorimetry

FDM:

Fused deposition modeling

HME:

Hot melt extrusion

IR:

Immediate release

PC:

Polycarbonate

PCL:

Poly(ε-caprolactone)

PLA:

Polylactic acid

PPD:

Pramipexole dihydrochloride monohydrate

PVA:

Polyvinyl alcohol

RP:

Rapid prototyping

SEM:

Scanning electron microscopy

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Acknowledgments and Disclosures

This study was supported by the Scientific and Technological Research Council of Turkey (TUBITAK) (grant number 217S456). The authors are thankful to Deva Pharmaceuticals (Turkey) for donating pramipexole dihydrochloride monohydrate, to Karadeniz Pharmaceutical Warehouse (Turkey) for providing Eudragit EPO and to Colorcon (Turkey) for providing POLYOXTM derivatives. None.

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Authors and Affiliations

  1. Department of Pharmaceutical Technology, Faculty of Pharmacy, Gazi University, 06330, Ankara, Turkey

    Hazal Ezgi Gültekin, Serdar Tort & Füsun Acartürk

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  1. Hazal Ezgi Gültekin
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Correspondence to Füsun Acartürk.

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Gültekin, H.E., Tort, S. & Acartürk, F. An Effective Technology for the Development of Immediate Release Solid Dosage Forms Containing Low-Dose Drug: Fused Deposition Modeling 3D Printing. Pharm Res 36, 128 (2019). https://doi.org/10.1007/s11095-019-2655-y

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