In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling

Recently, the development of Binder Jet 3D printing technology has promoted the research and application of personalized formulations, which are especially useful for children's medications. Additionally, physiological pharmacokinetic (PBPK) modeling can be used to guide drug development and dr...

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Main Authors: Xianfu Li (Author), En Liang (Author), Xiaoxuan Hong (Author), Xiaolu Han (Author), Conghui Li (Author), Yuxi Wang (Author), Zengming Wang (Author), Aiping Zheng (Author)
Format: Book
Published: MDPI AG, 2021-12-01T00:00:00Z.
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042 |a dc 
100 1 0 |a Xianfu Li  |e author 
700 1 0 |a En Liang  |e author 
700 1 0 |a Xiaoxuan Hong  |e author 
700 1 0 |a Xiaolu Han  |e author 
700 1 0 |a Conghui Li  |e author 
700 1 0 |a Yuxi Wang  |e author 
700 1 0 |a Zengming Wang  |e author 
700 1 0 |a Aiping Zheng  |e author 
245 0 0 |a In Vitro and In Vivo Bioequivalence Study of 3D-Printed Instant-Dissolving Levetiracetam Tablets and Subsequent Personalized Dosing for Chinese Children Based on Physiological Pharmacokinetic Modeling 
260 |b MDPI AG,   |c 2021-12-01T00:00:00Z. 
500 |a 10.3390/pharmaceutics14010020 
500 |a 1999-4923 
520 |a Recently, the development of Binder Jet 3D printing technology has promoted the research and application of personalized formulations, which are especially useful for children's medications. Additionally, physiological pharmacokinetic (PBPK) modeling can be used to guide drug development and drug dose selection. Multiple technologies can be used in combination to increase the safety and effectiveness of drug administration. In this study, we performed in vivo pharmacokinetic experiments in dogs with preprepared 3D-printed levetiracetam instant-dissolving tablets (LEV-IDTs). Bioequivalence analysis showed that the tablets were bioequivalent to commercially available preparations (Spritam<sup>®</sup>) for dogs. Additionally, we evaluated the bioequivalence of 3D-printed LEV-IDTs with Spritam<sup>®</sup> by a population-based simulation based on the established PBPK model of levetiracetam for Chinese adults. Finally, we established a PBPK model of oral levetiracetam in Chinese children by combining the physiological parameters of children, and we simulated the PK (pharmacokinetics) curves of Chinese children aged 4 and 6 years that were administered the drug to provide precise guidance on adjusting the dose according to the effective dose range of the drug. Briefly, utilizing both Binder jet 3D printing technology and PBPK models is a promising route for personalized drug delivery with various age groups. 
546 |a EN 
690 |a Binder jet 3D printing 
690 |a physiological pharmacokinetic modeling 
690 |a levetiracetam 
690 |a bioequivalence 
690 |a personalized dosing 
690 |a Pharmacy and materia medica 
690 |a RS1-441 
655 7 |a article  |2 local 
786 0 |n Pharmaceutics, Vol 14, Iss 1, p 20 (2021) 
787 0 |n https://www.mdpi.com/1999-4923/14/1/20 
787 0 |n https://doaj.org/toc/1999-4923 
856 4 1 |u https://doaj.org/article/5b766f2f13d2419a9e1e8110b5dc21a4  |z Connect to this object online.