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使用落滴试验方法研究粉末-黏合剂相互作用对药用片剂3D可打印性的影响。

Impact of powder-binder interactions on 3D printability of pharmaceutical tablets using drop test methodology.

作者信息

Sen Koyel, Mukherjee Raj, Sansare Sameera, Halder Aritra, Kashi Hooman, Ma Anson W K, Chaudhuri Bodhisattwa

机构信息

Department of Pharmaceutical Sciences, University of Connecticut.

Department of Statistics, University of Connecticut.

出版信息

Eur J Pharm Sci. 2021 May 1;160:105755. doi: 10.1016/j.ejps.2021.105755. Epub 2021 Feb 13.

Abstract

In this study, a pre-screening test has been developed for the binder-jet 3D printing process (BJ3DP) which has been validated using statistical analysis. The pre-screening test or drop test has been adapted from the wet granulation field and modified later on to be used for tablet manufacturing in BJ3DP. Initially, a total of eight powders and ten water-based binder solutions have been introduced in the preliminary test to understand the powder-binder interactions. Afterward, based on the preliminary test results, three blends were developed which had undergone the same drop test. All these powder and binder combinations were then used for 3D printing. The key parameters such as mechanical strength and shape factors of the drop test agglomerates and 3D printed tablets were then compared using multiple linear regressions. Few dimensionless parameters were introduced in this study such as binding capacity and binding index to capture the printability properties of the powders used in this study. Significant relations (p<0.05) were found between the drop test and the BJ3DP process. Application of drop test was carried out to establish a prescreening test, ii) to develop new blend formulations as well as iii) to develop a fundamental understanding of powder-binder interaction during BJ3DP process.

摘要

在本研究中,已针对粘结剂喷射3D打印工艺(BJ3DP)开发了一种预筛选测试,并通过统计分析进行了验证。该预筛选测试或跌落测试源自湿法制粒领域,后来经过修改用于BJ3DP中的片剂制造。最初,在初步测试中引入了总共八种粉末和十种水基粘结剂溶液,以了解粉末与粘结剂之间的相互作用。之后,根据初步测试结果,开发了三种混合物,并对其进行了相同的跌落测试。然后将所有这些粉末和粘结剂组合用于3D打印。然后使用多元线性回归比较了跌落测试团聚体和3D打印片剂的关键参数,如机械强度和形状因子。本研究中引入了一些无量纲参数,如结合能力和结合指数,以捕捉本研究中使用的粉末的可打印性。在跌落测试和BJ3DP工艺之间发现了显著关系(p<0.05)。进行跌落测试的应用是为了建立预筛选测试,ii)开发新的混合配方,以及iii)深入了解BJ3DP工艺过程中粉末与粘结剂的相互作用。

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