<p><i>Bacopa monnieri</i> (L.) Wettst, a traditional ayurvedic herb with cognitive-enhancing properties, faces clinical limitations due to poor oral bioavailability, short half-life, gastrointestinal irritation, and intense bitterness. This study aimed to develop taste-masked, extended-release (ER) tablets using an integrated hot-melt extrusion (HME) and fused deposition modeling (FDM) 3D printing approach. Filaments containing <i>B. monnieri</i> extract, Klucel Fusion™ HPC, and Plasdone™ S-630 Ultra were successfully extruded and printed into cylindrical tablets with varying infill densities to control drug release. Physicochemical characterization (FTIR, DSC, XRD, SEM) confirmed the amorphous dispersion of the extract and the absence of chemical interactions. In vitro dissolution revealed a tunable release profile: 10% infill tablets released 99% of the drug within 4&#xa0;h, while 100% infill tablets sustained release up to 12&#xa0;h via a biphasic mechanism of diffusion and erosion. Taste evaluation demonstrated effective bitterness masking, with salivary drug concentrations below the bitterness threshold (250&#xa0;µg/mL) and significantly reduced bitterness perception (<i>p</i> &lt; 0.0001) in human volunteers. The optimized tablets showed good mechanical strength, printability, and stability under accelerated conditions. These findings support HME-FDM 3D printing as a viable platform for personalized herbal drug delivery systems, enhancing therapeutic adherence and patient compliance.</p> Graphical abstract <p></p>

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Development of 3D-printed taste-masked extended-release tablet of Bacopa monnieri with HME-FDM technique: in vitro and in vivo study

  • Onkar Bhingoli,
  • Yogesh Jadhav,
  • Ravikiran Chabukswar,
  • Swapnil Kamble,
  • Prakash Naidu,
  • Aboli Girme,
  • Vilas Malode,
  • Ajay Dantuluri,
  • Priti Dhande,
  • Vaibhav Shinde,
  • Ashwin Mali

摘要

Bacopa monnieri (L.) Wettst, a traditional ayurvedic herb with cognitive-enhancing properties, faces clinical limitations due to poor oral bioavailability, short half-life, gastrointestinal irritation, and intense bitterness. This study aimed to develop taste-masked, extended-release (ER) tablets using an integrated hot-melt extrusion (HME) and fused deposition modeling (FDM) 3D printing approach. Filaments containing B. monnieri extract, Klucel Fusion™ HPC, and Plasdone™ S-630 Ultra were successfully extruded and printed into cylindrical tablets with varying infill densities to control drug release. Physicochemical characterization (FTIR, DSC, XRD, SEM) confirmed the amorphous dispersion of the extract and the absence of chemical interactions. In vitro dissolution revealed a tunable release profile: 10% infill tablets released 99% of the drug within 4 h, while 100% infill tablets sustained release up to 12 h via a biphasic mechanism of diffusion and erosion. Taste evaluation demonstrated effective bitterness masking, with salivary drug concentrations below the bitterness threshold (250 µg/mL) and significantly reduced bitterness perception (p < 0.0001) in human volunteers. The optimized tablets showed good mechanical strength, printability, and stability under accelerated conditions. These findings support HME-FDM 3D printing as a viable platform for personalized herbal drug delivery systems, enhancing therapeutic adherence and patient compliance.

Graphical abstract