Development of 3D-Printed Two-Compartment Capsular Devices for Pulsatile Release of Peptide and Permeation Enhancer.

IF 3.5 3区 医学 Q2 CHEMISTRY, MULTIDISCIPLINARY Pharmaceutical Research Pub Date : 2024-11-01 DOI:10.1007/s11095-024-03785-0
Pengchong Xu, Hanh Thuy Nguyen, Siyuan Huang, Huyen Tran
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Abstract

Objective: The oral absorption of a peptide is driven by a high local concentration of a permeation enhancer (PE) in the gastrointestinal tract. We hypothesized that a controlled release of both PE and peptide from a solid formulation, capable of maintaining an effective co-localized concentration of PE and peptide could enhance oral peptide absorption. In this study, we aimed to develop a 3D-printed two-compartment capsular device with controlled pulsatile release of peptide and sodium caprate (C10).

Methods: 3D-printed two-compartment capsular device was fabricated using a fused deposition modeling method. This device was then filled with LY peptide and C10. The release profile was modulated by changing the thickness and polymer type of the capsular device. USP apparatus II dissolution test was used to evaluate the impacts of device thickness and polymer selection on release profile in vitro. An optimal device was then enteric coated with HPMCAS.

Results: A strong linear relationship between the thickness of capsular devices and the delay in the release onset time was observed. An increase in the device thickness or the use of PLA decreased the release rate. The capsular device with compartment 1, compartment 2 and fence thickness of 0.4; 0.95 and 0.5 mm, respectively, and the use of PVA achieved desired pulsatile release profiles of both peptide and C10. Furthermore, enteric-coated capsular devices with HPMCAS had similar pulsatile release profiles compared to non-enteric coated devices.

Conclusion: These findings suggest potential application of 3D-printing techniques in the formulation development for complex modified drug release products.

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开发用于脉冲式释放多肽和渗透促进剂的三维打印两室囊式装置
目的:多肽的口服吸收是由胃肠道中高浓度的渗透促进剂(PE)驱动的。我们假设,从固体制剂中控制 PE 和肽的释放,使 PE 和肽保持有效的共定位浓度,可以促进口服肽的吸收。本研究旨在开发一种三维打印的两室胶囊装置,可控制肽和癸酸钠(C10)的脉动释放。方法:采用熔融沉积建模方法制造了三维打印双室囊式装置,然后在该装置中填充 LY 肽和 C10。通过改变胶囊装置的厚度和聚合物类型来调节释放曲线。USP 仪器 II 溶解试验用于评估装置厚度和聚合物选择对体外释放曲线的影响。然后用 HPMCAS 对最佳装置进行肠溶包衣:结果:观察到胶囊装置的厚度与释放开始时间的延迟之间存在很强的线性关系。装置厚度增加或使用聚乳酸会降低释放率。第 1 区、第 2 区和栅栏厚度分别为 0.4、0.95 和 0.5 毫米的胶囊装置以及 PVA 的使用都能达到理想的多肽和 C10 脉动释放曲线。此外,使用 HPMCAS 的肠溶胶囊装置与非肠溶胶囊装置相比,具有相似的脉动释放曲线:这些研究结果表明,三维打印技术在复杂改性药物释放产品的配方开发中具有潜在的应用价值。
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来源期刊
Pharmaceutical Research
Pharmaceutical Research 医学-化学综合
CiteScore
6.60
自引率
5.40%
发文量
276
审稿时长
3.4 months
期刊介绍: Pharmaceutical Research, an official journal of the American Association of Pharmaceutical Scientists, is committed to publishing novel research that is mechanism-based, hypothesis-driven and addresses significant issues in drug discovery, development and regulation. Current areas of interest include, but are not limited to: -(pre)formulation engineering and processing- computational biopharmaceutics- drug delivery and targeting- molecular biopharmaceutics and drug disposition (including cellular and molecular pharmacology)- pharmacokinetics, pharmacodynamics and pharmacogenetics. Research may involve nonclinical and clinical studies, and utilize both in vitro and in vivo approaches. Studies on small drug molecules, pharmaceutical solid materials (including biomaterials, polymers and nanoparticles) biotechnology products (including genes, peptides, proteins and vaccines), and genetically engineered cells are welcome.
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