Pharmacokinetic assessment and level-A IVIVC establishment of rifampicin-loaded 3D printed tablets using SLS 3D printing.

IF 3 Q2 PHARMACOLOGY & PHARMACY

Therapeutic delivery Pub Date : 2025-03-30 DOI:10.1080/20415990.2025.2484169

Tukaram Karanwad, Dimple S Lalchandani, Sachin B Jorvekar, Santa Mandal, Pawan Kumar Porwal, Roshan M Borkar, Subham Banerjee

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引用次数: 0

Abstract

Background: This study investigated the in vitro dissolution and in vivo absorption of rifampicin (RIF)-containing 3D-printed tablets using Selective Laser Sintering (SLS) technology.

Methods: In vitro dissolution was assessed in acidic (pH 1.2) and alkaline (pH 6.8) buffer media, while in vivo absorption was evaluated in a New Zealand White rabbit model. Both analytical and bioanalytical methods were rigorously developed and validated using LC-ESI-MS/MS, following ICH Q2 (R1) and FDA guidelines, respectively.

Results: In the acidic medium, 16.22% of RIF was released within the first 2 h, whereas in the alkaline medium, the release increased to 41.75%, indicating a sustained release from the sintered 3D printed tablets. Pharmacokinetic parameters and their corresponding values of C_max (445.38 ± 193.62 ng/mL), T_max (02 ± 0.00 hr), AUC_0-t (841.51 ± 334.13 ng.h/mL), AUC_0-∞ (861.66 ± 340.54 ng.h/mL), K_el (0.61 ± 0.13 h^-1), and t_1/2 (1.18 ± 0.25 hr) were obtained, demonstrating effective RIF absorption in the rabbit. Additionally, an in vitro-in vivo correlation (IVIVC) model was developed, demonstrating a good correlation between in vitro release and in vivo absorption, with R² value of 0.9696.

Conclusion: The results underscore the potential of SLS 3DP technology in advancing the development of RIF-containing 3D printed tablets by sustaining in vitro dissolution following in vivo absorption profiles.

查看原文本刊更多论文

SLS 3D打印载利福平3D打印片剂的药代动力学评价及a级IVIVC建立。

背景：本研究采用选择性激光烧结（SLS）技术研究了含利福平（RIF）的3d打印片剂的体外溶出度和体内吸收。方法：在酸性（pH 1.2）和碱性（pH 6.8）缓冲介质中测定体外溶出度，在新西兰大白兔模型中测定体内吸收。采用LC-ESI-MS/MS严格开发和验证了分析和生物分析方法，分别遵循ICH Q2 （R1）和FDA指南。结果：在酸性介质中，RIF在前2 h内释放16.22%，而在碱性介质中，RIF的释放量增加到41.75%，表明烧结3D打印片具有缓释作用。获得了Cmax（445.38±193.62 ng/mL）、Tmax（02±0.00 hr）、AUC0-t（841.51±334.13 ng.h/mL）、AUC0-∞（861.66±340.54 ng.h/mL）、Kel（0.61±0.13 h-1）、t1/2（1.18±0.25 hr）的药代动力学参数及其对应值，证明了RIF在兔体内的有效吸收。此外，建立了体外体内相关（IVIVC）模型，表明其体外释放与体内吸收相关性良好，R2值为0.9696。结论：SLS - 3DP技术在促进含rif的3D打印片剂的开发方面具有很大的潜力，该技术可以维持体内吸收后的体外溶出。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Therapeutic delivery PHARMACOLOGY & PHARMACY-

CiteScore

5.50

自引率

0.00%

发文量

期刊介绍： Delivering therapeutics in a way that is right for the patient - safe, painless, reliable, targeted, efficient and cost effective - is the fundamental aim of scientists working in this area. Correspondingly, this evolving field has already yielded a diversity of delivery methods, including injectors, controlled release formulations, drug eluting implants and transdermal patches. Rapid technological advances and the desire to improve the efficacy and safety profile of existing medications by specific targeting to the site of action, combined with the drive to improve patient compliance, continue to fuel rapid research progress. Furthermore, the emergence of cell-based therapeutics and biopharmaceuticals such as proteins, peptides and nucleotides presents scientists with new and exciting challenges for the application of therapeutic delivery science and technology. Successful delivery strategies increasingly rely upon collaboration across a diversity of fields, including biology, chemistry, pharmacology, nanotechnology, physiology, materials science and engineering. Therapeutic Delivery recognizes the importance of this diverse research platform and encourages the publication of articles that reflect the highly interdisciplinary nature of the field. In a highly competitive industry, Therapeutic Delivery provides the busy researcher with a forum for the rapid publication of original research and critical reviews of all the latest relevant and significant developments, and focuses on how the technological, pharmacological, clinical and physiological aspects come together to successfully deliver modern therapeutics to patients. The journal delivers this essential information in concise, at-a-glance article formats that are readily accessible to the full spectrum of therapeutic delivery researchers.