Advancing Personalized Medicine Through FDM 3D Printing: Ketoprofen Tablets with Customizable Drug Release Profiles...

Area of Science:

• Pharmaceutical Technology
• 3D Printing
• Drug Delivery Systems

Background:

• Fused deposition modeling (FDM) three-dimensional (3D) printing is an emerging technology for personalized oral dosage forms.
• Developing robust drug-loaded filaments with consistent properties is crucial for the success of FDM 3D printing in pharmaceuticals.
• This study focuses on ketoprofen-loaded filaments for immediate-release (IR) and sustained-release (SR) applications.

Purpose of the Study:

• To develop and characterize ketoprofen-loaded filaments using hot-melt extrusion (HME).
• To fabricate IR and SR ketoprofen tablets via FDM 3D printing.
• To evaluate the quality, drug release, and pharmacokinetic profiles of the 3D-printed tablets.

Main Methods:

• Ketoprofen filaments were prepared using Kollicoat® IR or hydroxypropyl methylcellulose (HPMC) with sorbitol and sodium lauryl sulfate (SLS).
• Filaments and 3D-printed tablets were characterized using techniques including SEM, ATR-FTIR, XRD, DSC, TGA, and USP testing.
• Dissolution studies and GastroPlus® simulations were performed for in vitro-in silico correlation (IVIVC).

Main Results:

• Kollicoat® IR-based filaments (F6) showed superior printability for IR tablets, while HPMC-based filaments (F13) were optimal for SR tablets.
• IR tablets achieved >80% ketoprofen release within 30 min, and SR tablets prolonged release up to 12 hours, following Higuchi and Korsmeyer-Peppas kinetics.
• All quality attributes met USP limits, and GastroPlus® simulations supported IVIVC.

Conclusions:

• An integrated workflow was established for producing IR and SR ketoprofen tablets using a single FDM 3D printing platform.
• The study demonstrates the feasibility of FDM 3D printing for point-of-care, personalized medicine with tailored drug release.
• This approach offers a robust strategy for manufacturing customized oral dosage forms.