Mohammed H, Briscoe B J, Pitt K G
Department of Chemical Engineering, Imperial College, London, UK.
Eur J Pharm Biopharm. 2006 May;63(1):19-25. doi: 10.1016/j.ejpb.2005.10.001. Epub 2005 Dec 2.
This paper describes and interprets the coherence and the tensile strength of bi-component compacted tablets, composing a mixture of a poorly compactable drug, paracetamol and a very cohesive and ductile carrier, microcrystalline cellulose (MCC), Avicel PH 102, using the concepts of the stored elastic strain in conjunction with the particle size and the relative volume fraction of the powders. Cylindrical compacts of the bi-component tablets, at various compositions formed at a common ultimate stress of 99 MPa, were subsequently fractured using the indirect tensile test method (Brazilian test method) to obtain a measure of their tensile strength. Various inter-relations between the compaction and tensile rupture characteristics are described. A simple model, which may predict the required volume fraction of MCC to produce a cohesively viable tablet is suggested, and applied to the current system. The results show to some extent the consistency of the suggested model with the experimental results.
本文运用储存弹性应变的概念,结合粉末的粒径和相对体积分数,描述并解释了双组分压制片剂的内聚性和抗张强度。该双组分片剂由难压制的药物对乙酰氨基酚和极具粘性与延展性的载体微晶纤维素(MCC,型号为Avicel PH 102)混合而成。采用间接拉伸试验方法(巴西试验方法)对在99MPa的共同极限应力下形成的不同组成的双组分片剂圆柱形压坯进行断裂试验,以测定其抗张强度。文中描述了压制和拉伸断裂特性之间的各种相互关系。提出了一个简单模型,该模型可预测生产具有内聚性的可行片剂所需的微晶纤维素体积分数,并将其应用于当前体系。结果在一定程度上表明了所提模型与实验结果的一致性。