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<p>Vitamin D₃ (cholecalciferol) deficiency remains a global health concern, exacerbated by poor patient compliance with conventional oral supplements, especially among pediatric, geriatric, and dysphagic populations. Orally dissolving films (ODFs) provide a promising, patient-friendly alternative, offering rapid disintegration and potential for improved bioavailability through mucosal absorption. This work emphasizes the role of extrusion-based 3D printing as a platform for personalized oral drug delivery, enabling precise, on-demand dose customization without reformulation. Vitamin D₃ was selected as a model lipophilic micronutrient to demonstrate the feasibility of individualized dosing, micro-dose accuracy, and reproducibility within a Quality by Design (QbD) framework. The developed 3D-printed orally dissolving films highlight the potential of patient-centric manufacturing for pediatric, geriatric, and dysphagic populations. Hydroxypropyl methylcellulose (HPMC)-based substrates were optimized via a 2³ factorial design, identifying an ideal HPMC concentration range of 55–85%, with propylene glycol and glycerin concentrations optimized to achieve balanced mechanical strength and disintegration performance. The Vitamin D₃ ink formulation was further optimized using a 3² factorial design, resulting in an ink with a viscosity of 23,092 ± 460 cP, facilitating precise droplet formation and consistent dosing. Process parameters, including a 22G nozzle, pneumatic pressure of 96&#xa0;kPa, and drying at 50&#xa0;°C for 11&#xa0;min, were optimized to ensure high spatial resolution and stable deposition. The optimized films exhibited rapid in vitro disintegration within 29.3 ± 2.5&#xa0;s, tensile strength of 17.7 ± 1.5&#xa0;MPa, and surface pH of 6.60 ± 0.17, supporting mucosal compatibility. Each film accurately delivered 800 IU of Vitamin D₃ per 20&#xa0;µg dose. Stability studies demonstrated that the films retained 98.7 ± 1.2% of their initial Vitamin D₃ content after six months under standard storage conditions (25&#xa0;°C/60% RH), and over 95% even under accelerated conditions (40&#xa0;°C/75% RH). These findings underscore the potential of 3D-printed ODFs as a novel, effective, and patient-centric platform for addressing Vitamin D₃ deficiency, combining precise dosing, improved stability, and enhanced patient acceptability.</p>

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Development and Optimization of 3D-Printed Orally Dissolving Films of Vitamin D₃ Using a Quality by Design Approach

  • 期刊论文

  • 发表日期：

    2026年3月6日

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  • Priya D Dule,
  • Vaishali A. Kilor,
  • Nidhi Sapkal,
  • Minal Bonde,
  • Kumar Pratyush,
  • Kunal Banode

摘要

Vitamin D₃ (cholecalciferol) deficiency remains a global health concern, exacerbated by poor patient compliance with conventional oral supplements, especially among pediatric, geriatric, and dysphagic populations. Orally dissolving films (ODFs) provide a promising, patient-friendly alternative, offering rapid disintegration and potential for improved bioavailability through mucosal absorption. This work emphasizes the role of extrusion-based 3D printing as a platform for personalized oral drug delivery, enabling precise, on-demand dose customization without reformulation. Vitamin D₃ was selected as a model lipophilic micronutrient to demonstrate the feasibility of individualized dosing, micro-dose accuracy, and reproducibility within a Quality by Design (QbD) framework. The developed 3D-printed orally dissolving films highlight the potential of patient-centric manufacturing for pediatric, geriatric, and dysphagic populations. Hydroxypropyl methylcellulose (HPMC)-based substrates were optimized via a 2³ factorial design, identifying an ideal HPMC concentration range of 55–85%, with propylene glycol and glycerin concentrations optimized to achieve balanced mechanical strength and disintegration performance. The Vitamin D₃ ink formulation was further optimized using a 3² factorial design, resulting in an ink with a viscosity of 23,092 ± 460 cP, facilitating precise droplet formation and consistent dosing. Process parameters, including a 22G nozzle, pneumatic pressure of 96 kPa, and drying at 50 °C for 11 min, were optimized to ensure high spatial resolution and stable deposition. The optimized films exhibited rapid in vitro disintegration within 29.3 ± 2.5 s, tensile strength of 17.7 ± 1.5 MPa, and surface pH of 6.60 ± 0.17, supporting mucosal compatibility. Each film accurately delivered 800 IU of Vitamin D₃ per 20 µg dose. Stability studies demonstrated that the films retained 98.7 ± 1.2% of their initial Vitamin D₃ content after six months under standard storage conditions (25 °C/60% RH), and over 95% even under accelerated conditions (40 °C/75% RH). These findings underscore the potential of 3D-printed ODFs as a novel, effective, and patient-centric platform for addressing Vitamin D₃ deficiency, combining precise dosing, improved stability, and enhanced patient acceptability.