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<p>Fused deposition modeling (FDM) is a versatile and cost-effective technique for producing personalized pharmaceutical dosage forms. Advancing this approach requires the development of novel excipients to overcome the limitations of conventional drug formulation additives. Naturally derived excipients, valued for their biocompatibility, are increasingly explored in drug design, with soy protein products emerging as promising candidates due to their low cost and availability. This study investigated the possibility of incorporation of soy protein concentrate (SPC) into filaments prepared via hot-melt extrusion (HME) for FDM 3D printing of ketoprofen tablets. Additionally, the effects of SPC content, sodium starch glycolate (SSG) content and tablet geometry on ketoprofen release rate were evaluated. SPC was successfully incorporated at 10% w/w and demonstrated greater potential as a release-rate enhancer compared to the traditional superdisintegrant SSG, in both pH = 1.2 and pH = 6.8 dissolution media. Drug release kinetics were influenced by both formulation composition and dosage form geometry, highlighting the complex interplay between material properties and printing design. FTIR and DSC analyses suggested the formation of a solid dispersion of ketoprofen within the hydroxypropyl cellulose polymer matrix, with no evidence of chemical interactions with any of the excipients. These results confirm the successful processability of SPC by both HME and FDM 3D printing and emphasize the value of a holistic approach in designing 3D-printed pharmaceutical dosage forms, integrating excipient selection, formulation composition, and printing parameters to optimize drug release performance and enable the production of tailored, effective therapies.</p>

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Functionality of Soy Protein Concentrate as Excipient in FDM 3D Printed Solid Dosage Forms

  • 期刊论文

  • 发表日期：

    2026年3月7日

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  • Jelena Čanji Panić,
  • Nemanja Todorović,
  • Senka Popović,
  • Ivan Ristić,
  • Nataša Milošević,
  • Boris Milijašević,
  • Dejan Movrin,
  • Mladena Lalić-Popović

摘要

Fused deposition modeling (FDM) is a versatile and cost-effective technique for producing personalized pharmaceutical dosage forms. Advancing this approach requires the development of novel excipients to overcome the limitations of conventional drug formulation additives. Naturally derived excipients, valued for their biocompatibility, are increasingly explored in drug design, with soy protein products emerging as promising candidates due to their low cost and availability. This study investigated the possibility of incorporation of soy protein concentrate (SPC) into filaments prepared via hot-melt extrusion (HME) for FDM 3D printing of ketoprofen tablets. Additionally, the effects of SPC content, sodium starch glycolate (SSG) content and tablet geometry on ketoprofen release rate were evaluated. SPC was successfully incorporated at 10% w/w and demonstrated greater potential as a release-rate enhancer compared to the traditional superdisintegrant SSG, in both pH = 1.2 and pH = 6.8 dissolution media. Drug release kinetics were influenced by both formulation composition and dosage form geometry, highlighting the complex interplay between material properties and printing design. FTIR and DSC analyses suggested the formation of a solid dispersion of ketoprofen within the hydroxypropyl cellulose polymer matrix, with no evidence of chemical interactions with any of the excipients. These results confirm the successful processability of SPC by both HME and FDM 3D printing and emphasize the value of a holistic approach in designing 3D-printed pharmaceutical dosage forms, integrating excipient selection, formulation composition, and printing parameters to optimize drug release performance and enable the production of tailored, effective therapies.