期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 108, 期 2, 页码 977-986出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2018.10.001
关键词
semi-solid extrusion 3D printing; levetiracetam; dose-flexible regulation system; individual-tailored medicines; linear correlation; patterns; mechanical properties; dissolution behavior
资金
- The research on the key technology of 3D-printing techniques in the field of pharmaceutical preparation from the National Science and Technology Major Project [2017ZX09201003-011]
- Jingxin Pharmaceutical Company, Ltd. (Zhejiang, China)
Levetiracetam therapy is often associated with high levels of individual variation in the recommended dose required to achieve preferential treatment. Thus, a reliable and dynamic regulation system to accurately tailor dose is necessary. The main objective of this study is to explore and prepare a dose-flexible control system suitable for rapid release tablets equipped with high drug loading and a cylindrical model design. Semi-solid extrusion 3-dimensional printing was utilized to fabricate a series of tablets of increased volume. This method was compatible with 3 patterns to regulate the volumes to manipulate the tablet mass and achieve tailored personalized precision dosing. All tablets from each pattern exhibited a smooth surface and regular shape, as well as sufficient mechanical strength. A good linear correlation between the mass and theoretical volume of the tablets was maintained, regardless of the pattern used. The range of dose accuracy was between 103.3% and 96.2%, with an acceptable variation coefficient in the range of 0.6%-3.2%. Faster release behavior for levetiracetam can be achieved from the small-sized tablets due to their larger surface area/mass ratio. All the results demonstrated the potential and capability of semi-solid extrusion 3-dimensional printing as a novel pharmaceutical manufacturing technique to provide a dynamic and highly accurate controllable system for preparing patient-tailored medicines. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
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