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Comparison of Flow and Compression Properties of Four Lactose-Based Co-Processed Excipients: Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®
Pharmaceutics ( IF 5.4 ) Pub Date : 2021-09-16 , DOI: 10.3390/pharmaceutics13091486
Martin Dominik 1 , Barbora Vraníková 2 , Petra Svačinová 2 , Jan Elbl 1 , Sylvie Pavloková 1 , Barbora Blahová Prudilová 3 , Zdeňka Šklubalová 2 , Aleš Franc 1
Affiliation  

The utilization of co-processed excipients (CPEs) represents a novel approach to the preparation of orally disintegrating tablets by direct compression. Flow, consolidation, and compression properties of four lactose-based CPEs—Cellactose® 80, CombiLac®, MicroceLac® 100, and StarLac®—were investigated using different methods, including granulometry, powder rheometry, and tablet compaction under three pressures. Due to the similar composition and the same preparation technique (spray drying), the properties of CPEs and their compacts were generally comparable. The most pronounced differences were observed in flowability, undissolved fraction after 3 min and 24 h, energy of plastic deformation (E2), ejection force, consolidation behavior, and compact friability. Cellactose® 80 exhibited the most pronounced consolidation behavior, the lowest values of ejection force, and high friability of compacts. CombiLac® showed excellent flow properties but insufficient friability, except for compacts prepared at the highest compression pressure (182 MPa). MicroceLac® 100 displayed the poorest flow properties, lower ejection forces, and the best mechanical resistance of compacts. StarLac® showed excellent flow properties, the lowest amounts of undissolved fraction, the highest ejection force values, and the worst compact mechanical resistance. The obtained results revealed that higher compression pressures need to be used or further excipients have to be added to all tested materials in order to improve the friability and tensile strength of formed tablets, except for MicroceLac® 100.

中文翻译:

四种基于乳糖的协同加工赋形剂的流动和压缩特性比较:Cellactose® 80、CombiLac®、MicroceLac® 100 和 StarLac®

协同加工赋形剂 (CPE) 的使用代表了一种通过直接压制制备口腔崩解片的新方法。使用不同的方法研究了四种基于乳糖的 CPE——Cellactose ® 80、CombiLac ®、MicroceLac ® 100 和 StarLac ® 的流动、固结和压缩特性,包括粒度测定、粉末流变测定和在三种压力下压片。由于相似的成分和相同的制备技术(喷雾干燥),CPE 及其压块的性能通常相当。在流动性、3 分钟和 24 小时后的未溶解部分、塑性变形能量 (E 2)、顶出力、固结行为和压实脆碎度。Cellactose ® 80 表现出最显着的固结行为、最低的顶出力值和压块的高脆碎度。CombiLac ®表现出优异的流动性能,但脆性不足,除了在最高压缩压力 (182 MPa) 下制备的压块。MicroceLac ® 100 表现出最差的流动性能、较低的顶出力和最好的压块机械阻力。星胶®表现出优异的流动性能、最低的未溶解分数、最高的顶出力值和最差的压实机械阻力。获得的结果表明,除了 MicroceLac ® 100之外,需要使用更高的压缩压力或必须向所有测试材料中添加更多赋形剂,以提高成型片剂的脆碎度和拉伸强度。
更新日期:2021-09-16
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