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Fabrication of 3D-Printed Hydrocortisone Triple Pulsatile Tablet Using Fused Deposition Modelling Technology

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Abstract

Hydrocortisone (HC) is the optimal drug for adolescents diagnosed with congenital adrenal hyperplasia (CAH). Because traditional dosage regimens HC are inconvenient, our study used fused deposition modeling (FDM) three-dimensional (3D) printing technology to solve the problems caused by traditional preparations. First, we designed a core–shell structure tablet with an inner instant release component and an outer delayed release shell. The instant release component was Kollicoat IR: glycerol (GLY): HC = 76.5:13.5:10. Then, we used Affinisol® HPMC 15LV to realize delayed release. Furthermore, we investigated the relationship between the thickness of the delayed release shell and the delayed release time, and an equation was derived through binomial regression analysis. Based on that equation, a novel triple pulsatile tablet with an innovative structure was devised. The tablet was divided into three components, and the drug was released multiple times at different times. The dose and release rate of the tablets can be adjusted by modifying the infill rate of the printing model. The results indicated that the triple pulsatile tablet exhibited desirable release behavior in vitro. Moreover, the physicochemical properties of the drug, excipients, filaments, and tablets were characterized. All these results indicate that the FDM 3D printing method is a convenient technique for producing preparations with intricate structures.

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Authors and Affiliations

  1. School of Pharmacy, Liaoning University, 66 Chongshan Middle Road, Shenyang, 110036, China

    Hao Chen, Xiangyu Wang & Hao Pan

  2. School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, 110016, China

    Hao Chen, Kai Zheng, Tianshi Bu & Xin Li

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  1. Hao Chen
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Contributions

Hao Chen: conceptualization, methodology, investigation, writing—original draft; Kai Zheng: software, validation, data curation; Tianshi Bu: resources, project administration, formal analysis, writing—review and editing; Xin LI: writing—review and editing, visualization; Xiangyu Wang: writing—review and editing; Hao Pan: conceptualization, methodology, supervision, funding acquisition.

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Chen, H., Zheng, K., Bu, T. et al. Fabrication of 3D-Printed Hydrocortisone Triple Pulsatile Tablet Using Fused Deposition Modelling Technology. AAPS PharmSciTech 25, 58 (2024). https://doi.org/10.1208/s12249-024-02757-2

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