PURPOSE:Assessment of the extrudability of mixtures of saturated polyglycolysed glycerides used as carriers for poorly soluble drugs. METHODS:Three different mixtures of saturated polyglycolysed glycerides were extruded in a ram extruder at different rates and using different dies. The force applied to the ram and its displacement were recorded and used to determine the "specific work of extrusion" and pursuit rheometric determinations, according to the Bagley's approach. RESULTS:As the melting range of the mixtures, or the length of the dies increased, the higher the "specific work of extrusion" observed. From the rheometric analysis, viscoelastic properties were identified and decomposed into plastic and elastic components. The elastic component contributed more to the total pressure loss, and for the majority of the cases, was higher than the plastic component. From the Bagley plot it was possible to calculate the wall shear stress (sigma w), that increased with the melting range of the materials and the shear rate applied (gamma). The viscosity (eta) decreased as the shear rate increased, reflecting a non-Newtonian behavior of the materials. Finally, materials showing lower viscosities required less work to produce the extrudates. CONCLUSIONS:This study has (a) shown the possibility of preparing extrudates from different mixtures of polyglycolysed glycerides alone in a non-aqueous environment, (b) demonstrated the usefulness of the "specific work of extrusion," and (c) revealed through the rheometric studies the viscoelastic nature of the materials quantifying the contribution of the elastic and the plastic components for the total pressure loss.

译文

用途:评估用作难溶性药物载体的饱和聚乙二醇水解甘油酯混合物的可挤出性。
方法:将三种不同的饱和多聚甘油水解甘油酯混合物以不同的速率和使用不同的模具在ram挤出机中挤出。根据Bagley的方法,记录施加在撞锤上的力及其位移,并将其用于确定“挤压的特定功”并进行流变测定。
结果:随着混合物的熔化范围或模具长度的增加,观察到的“挤出比功”越高。通过流变分析,可以识别粘弹性并分解为塑性和弹性成分。弹性成分对总压力损失的贡献更大,并且在大多数情况下高于塑料成分。根据Bagley图,可以计算壁剪切应力(σw),该应力随材料的熔化范围和施加的剪切速率(γ)而增加。粘度(η)随着剪切速率的增加而降低,反映出材料的非牛顿行为。最后,显示出较低粘度的材料需要较少的工作来生产挤出物。
结论:这项研究表明:(a)在非水环境中,仅由聚甘油水解甘油酯的不同混合物制备挤出物的可能性;(b)证明了“挤出的特殊作用”的有效性;(c)通过流变学研究了材料的粘弹性,量化了弹性和塑料成分对总压力损失的贡献。

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