Jin-Hyuk Jeong, Chang-Soo Han, Ji-Hyun Kang, Kwang-Hwi Yoo, Woong-Young Jung, Yun-Sang Park, Dong-Wook Kim, Chun-Woong Park
{"title":"Preparation and characterization of immediate release 3D printed tablets using hot melt extruded amorphous cyclosporine a filament.","authors":"Jin-Hyuk Jeong, Chang-Soo Han, Ji-Hyun Kang, Kwang-Hwi Yoo, Woong-Young Jung, Yun-Sang Park, Dong-Wook Kim, Chun-Woong Park","doi":"10.1080/10837450.2025.2472893","DOIUrl":null,"url":null,"abstract":"<p><p>3D printing technology is gaining attention as a next-generation approach to drug formulation. Among 3D printing techniques, fused deposition modeling is cost-effective but depends heavily on suitable filaments. Hot melt extrusion enables filament production by incorporating poorly water-soluble drugs like cyclosporine A into polymers to form solid dispersions. However, achieving immediate release formulations with 3D printing remains challenging due to issues such as inadequate tablet disintegration or drug entrapment within the polymer matrix. This study aimed to develop and evaluate immediate release 3D-printed cyclosporine A tablets using HME filaments. Three parameters were modified in the 3D printing process: varying fill speeds, infill densities, and channel lengths. Filaments composed of Kollidon<sup>®</sup> VA 64 and HPC-SSL (1:1) were used to print tablets. Solid-state analysis confirmed cyclosporine A 's amorphous state and partial crystallinity in Xylisorb<sup>®</sup> 300. Dissolution studies revealed that lower infill densities (30%) and fewer walls enhanced drug release by increasing internal void space and reducing hardness. Conversely, greater tablet height (channel length) delayed dissolution. These findings emphasize the critical role of geometric design in drug release, showcasing the potential of 3D printing to create personalized dosage forms tailored to patient needs by optimizing structural parameters.</p>","PeriodicalId":20004,"journal":{"name":"Pharmaceutical Development and Technology","volume":" ","pages":"1-11"},"PeriodicalIF":2.6000,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Development and Technology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10837450.2025.2472893","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
3D printing technology is gaining attention as a next-generation approach to drug formulation. Among 3D printing techniques, fused deposition modeling is cost-effective but depends heavily on suitable filaments. Hot melt extrusion enables filament production by incorporating poorly water-soluble drugs like cyclosporine A into polymers to form solid dispersions. However, achieving immediate release formulations with 3D printing remains challenging due to issues such as inadequate tablet disintegration or drug entrapment within the polymer matrix. This study aimed to develop and evaluate immediate release 3D-printed cyclosporine A tablets using HME filaments. Three parameters were modified in the 3D printing process: varying fill speeds, infill densities, and channel lengths. Filaments composed of Kollidon® VA 64 and HPC-SSL (1:1) were used to print tablets. Solid-state analysis confirmed cyclosporine A 's amorphous state and partial crystallinity in Xylisorb® 300. Dissolution studies revealed that lower infill densities (30%) and fewer walls enhanced drug release by increasing internal void space and reducing hardness. Conversely, greater tablet height (channel length) delayed dissolution. These findings emphasize the critical role of geometric design in drug release, showcasing the potential of 3D printing to create personalized dosage forms tailored to patient needs by optimizing structural parameters.
期刊介绍:
Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology.
Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as:
-Preformulation and pharmaceutical formulation studies
-Pharmaceutical materials selection and characterization
-Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation
-QbD in the form a risk assessment and DoE driven approaches
-Design of dosage forms and drug delivery systems
-Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies
-Drug delivery systems research and quality improvement
-Pharmaceutical regulatory affairs
This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.