Comparison of three methods for assessment of drug elution: In vitro elution of gentamicin from a collagen-based scaffold

Caroline Billings, David E. Anderson
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Abstract

In vitro drug elution experiments are commonly performed when evaluating the fitness of drug delivery devices for in vivo use. Evaluation of drug elution characteristics spans many drug delivery applications including local delivery of antimicrobials and chemotherapeutics, and is of particular interest for prevention and treatment of orthopedic infections. Despite widespread utility, there is little agreement on methodology to perform such studies, and there are recognized limitations in published works. We evaluated three of the most commonly reported in vitro drug elution methods. We utilized a commercially available collagen matrix (Fibro-Gide®, Geistlich) and an antibiotic that is widely used for local antimicrobial therapy (gentamicin). The protocols used are: 1. complete replacement of media and washing of device, 2. complete replacement of media without washing, or 3. partial replacement of media. The results show statistically significant differences in elution characteristics among the three methods utilizing this delivery vehicle and drug. These results may provide the framework for moving toward more consistent methodology for in vitro elution experiments and address certain acknowledged limitations in the literature.
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三种药物洗脱评价方法的比较:体外洗脱庆大霉素从胶原基支架
体外药物洗脱实验通常在评估药物递送装置在体内使用的适合性时进行。药物洗脱特性的评估涵盖了许多药物递送应用,包括抗菌药物和化疗药物的局部递送,并且对预防和治疗骨科感染特别感兴趣。尽管效用广泛,但在进行此类研究的方法上几乎没有达成一致,而且已发表的作品也存在公认的局限性。我们评估了三种最常见的体外药物洗脱方法。我们使用了市售的胶原基质(Fibro-Gide®,Geistlich)和一种广泛用于局部抗菌治疗的抗生素(庆大霉素)。使用的协议有:1。完成介质更换和设备清洗,2。在不洗涤的情况下完全更换介质,或3。部分更换介质。结果显示,在使用该递送载体和药物的三种方法之间,洗脱特性存在统计学上的显著差异。这些结果可能为体外洗脱实验提供更一致的方法论框架,并解决文献中公认的某些局限性。
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