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The impact of roller compaction and tablet compression on physicomechanical properties of pharmaceutical excipients

机译:碾压和压片对药用辅料物理力学性能的影响

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Material properties play a significant role in pharmaceutical processing. The impact of roller compaction (RC) and tablet compression on solid fraction (SF), tensile strength (TS) and flexural modulus (FM) of Avicel DG [co-processed excipient with 75% microcrystalline cellulose (MCC) and 25% anhydrous dibasic calcium phosphate (DCPA)], lactose and 1: 1 Mixture of the two was studied. Materials were roller compacted at different force and roller type and compressed into tablets over a range of compression pressures (CP). SF, TS and FM were determined for ribbons and tablets. Roller force was a significant variable affecting SF while roller type was not. Both SF and TS of tablets increased with CP with Avicel DG exhibiting greater TS than that of 1: 1 Mixture while tablets of lactose had the lowest TS. The TS of tablets decreased exponentially with tablet porosity. Ribbon of Avicel DG had higher TS and lower SF than lactose and greater reworkability. This is attributed to plastic deformation of MCC resulting in high degree of bonding and fragmentation of DCPA that fills the void spaces during tablet compression. The lack of significant increase in SF and low tablet TS for lactose upon compression is likely due to its brittle fragmentation and some elastic recovery as shown by the high FM.
机译:材料特性在制药过程中起着重要作用。辊压(RC)和片剂压片对Avicel DG [与75%微晶纤维素(MCC)和25%无水二元碱共处理的赋形剂)的固体分数(SF),抗张强度(TS)和弯曲模量(FM)的影响[磷酸钙(DCPA)],乳糖和两者的1:1混合物进行了研究。将材料以不同的力和辊类型进行辊压,并在一定的压缩压力(CP)范围内压制成片剂。测定色带和片剂的SF,TS和FM。辊力是影响SF的重要变量,而辊型则不是。 CP可使片剂的SF和TS均增加,Avicel DG的TS大于1:1混合物,而乳糖的TS最低。片剂的TS随孔隙率呈指数下降。与乳糖相比,Avicel DG的碳带具有更高的TS和更低的SF,并且具有更高的可返工性。这归因于MCC的塑性变形,从而导致DCPA高度粘结和破碎,从而在压片过程中充满了空隙。乳糖压缩后,SF缺乏明显增加,而片剂TS较低,这可能是由于其脆性碎裂和高FM所显示的一些弹性恢复所致。

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