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. 2019 Oct 30;11(11):564.
doi: 10.3390/pharmaceutics11110564.

Customized Novel Design of 3D Printed Pregabalin Tablets for Intra-Gastric Floating and Controlled Release Using Fused Deposition Modeling

Affiliations

Customized Novel Design of 3D Printed Pregabalin Tablets for Intra-Gastric Floating and Controlled Release Using Fused Deposition Modeling

Shrawani Lamichhane et al. Pharmaceutics. .

Abstract

Three-dimensional (3D) printing has been recently employed in the design and formulation of various dosage forms with the aim of on-demand manufacturing and personalized medicine. In this study, we formulated a floating sustained release system using fused deposition modeling (FDM). Filaments were prepared using hypromellose acetate succinate (HPMCAS), polyethylene glycol (PEG 400) and pregabalin as the active ingredient. Cylindrical tablets with infill percentages of 25%, 50% and 75% were designed and printed with the FDM printer. An optimized formulation (F6) was designed with a closed bottom layer and a partially opened top layer. Filaments and tablets were characterized by means of fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and thermogravimetric analysis (TGA). The results show that the processing condition did not have a significant effect on the stability of the drug and the crystallinity of the drug remained even after printing. A dissolution study revealed that drug release is faster in an open system with low infill percentage compared to closed systems and open systems with a high infill ratio. The optimized formulation (F6) with partially opened top layer showed zero-order drug release. The results show that FDM printing is suitable for the formulation of floating dosage form with the desired drug release profile.

Keywords: 3D printing; FMD; controlled release; gastric floating; pregabalin.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Design and internal structures of tablets. Design of preliminary cylindrical tablets (A) and slicing of tablets with infill percentages of 25%, 50% and 75%, left to right (B).
Figure 2
Figure 2
Prepared filaments and tablets. Drug loaded filaments (A), printed open system tablets with 25%, 50% and 75% infill left to right (B), and printed closed system tablet (C).
Figure 3
Figure 3
Physical characterization of printed tablets. Fourier-transform infrared spectroscopy (A), X-ray powder diffractometry (B), differential scanning calorimetry (C), and thermogravimetric analysis (D).
Figure 4
Figure 4
SEM image of filament and tablets. Outer surface of filament (A), side view of top layer (B), and center view of different layers (C).
Figure 5
Figure 5
Floating study of prepared formulations. Open system (A), closed system (B), and optimized formulation (C) over 1, 8 and 24 h (left to right).
Figure 6
Figure 6
Floating mechanism of optimized formulation. The internal structure of tablet is composed of a grid infill with void space filled with air so that the tablet has low density, which helps in buoyancy of the tablet in media.
Figure 7
Figure 7
In vitro drug release study. Closed systems (A), open systems (B), and optimized formulation with commercial product (C).
Figure 8
Figure 8
Top view and side view of optimized formulation. Design of unique shaped optimized formulation (A), slicing of tablets with 25% infill (B) and printed tablets (C).
Figure 9
Figure 9
Drug release kinetics fitted to various models: Zero-order (A), Higuchi model (B), Hixon-Crowell model (C), and First-order (D).

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