连续湿造粒中螺杆元件影响的系统研究

IF 5.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Katharina Kiricenko , Robin Meier , Peter Kleinebudde
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引用次数: 0

摘要

双螺杆湿法制粒(TSG)是一种连续生产技术,既可将颗粒剂作为最终剂型,也可作为片剂或胶囊灌装前的中间体。考虑到影响颗粒和片剂质量的各种参数,实施 TSG 需要对工艺有全面的了解。本研究针对乳糖-微晶纤维素(lactose-MCC)和布洛芬-甘露醇(IBU)制剂,采用系统方法研究了螺杆配置对颗粒特性的影响,然后进行压片。正如其他研究人员所观察到的那样,影响最大的因素是影响颗粒大小、强度和可压片性的 L/S 比率。与 IBU 制剂一样,在螺杆末端引入齿状混合元件会导致过大颗粒的比例很高,数值在 36% 到 78% 之间。增加捏合元件(KE)的厚度会使颗粒更致密、更不易碎,同时降低片剂的抗拉强度。使用更多的捏合元件、更大的厚度或交错角度进行制粒,可增加扭矩值和 30 至 65 秒的停留时间。一般来说,IBU 颗粒表现出较高的可压片性,需要较低的压缩压力来获得足够的拉伸强度。在 50 兆帕的压缩压力下,至少包含一个捏合区的 IBU 片剂的压缩压力约为 2.5 兆帕,而乳糖-MCC 的压缩压力为 0.5 兆帕。总之,通过改变螺杆设计,TSG 工艺表现出了稳健性,对后续压片工艺的影响极小。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Systematic investigation of the impact of screw elements in continuous wet granulation

Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and tablet quality. This study investigates the impact of screw configuration on granule properties followed by tableting, using a systematic approach for lactose-microcrystalline cellulose (lactose-MCC) and ibuprofen-mannitol (IBU) formulations. The most affecting factor, as observed by other researchers, was the L/S ratio impacting the granule size, strength and tabletability. Introducing tooth-mixing-elements at the end of the screw, as for the IBU formulation, resulted in a high proportion of oversized granules, with values between 36% and 78%. Increasing the thickness of kneading elements (KEs) produced denser, less friable granules with reduced tablet tensile strength. Granulation with more KEs, larger thickness or stagger angle increased torque values and residence time from 30 to 65 s. Generally, IBU granules exhibited high tabletability, requiring low compression pressure for sufficient tensile strength. At a compression pressure of 50 MPa, IBU tablets where at least one kneading zone was included resulted in approximately 2.5 MPa compared to lactose-MCC with 0.5 MPa. In conclusion, the TSG process demonstrated robustness by varying the screw design with minimal impact on subsequent tableting processes.

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来源期刊
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
6.60
自引率
0.00%
发文量
32
审稿时长
24 days
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