Department of Chemical and Biological Engineering, University of Colorado, Boulder, Boulder, CO, 80303, USA.
Department of Pharmaceutical Chemistry, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.
J Pharm Sci. 2024 Nov;113(11):3238-3245. doi: 10.1016/j.xphs.2024.08.005. Epub 2024 Aug 22.
Deep infection is the second most common complication of arthroplasty following loosening of the implant. Antibiotic-loaded bone cements (ALBCs) and high concentrations of systemic broad-spectrum antibiotics are commonly used to prevent infections following injury and surgery. However, clinical data fails to show that ALBCs are effective against deep infection, and negative side effects can result following prolonged administration of antibiotics. Additionally, the rise of multidrug resistant (MDR) bacteria provides an urgent need for alternatives to broad-spectrum antibiotics. Phage therapy, or the use of bacteriophages (viruses that infect bacteria) to target pathogenic bacteria, might offer a safe alternative to combat MDR bacteria. Application of phage therapy in the setting of deep infections requires formulation strategies that would stabilize bacteriophage against chemical and thermal stress during bone-cement polymerization, that maintain bacteriophage activity for weeks or months at physiological temperatures, and that allow for sustained release of phage to combat slow-growing, persistent bacteria. Here, we demonstrate the formulation of three phages that target diverse bacterial pathogens, which includes spray-drying of the particles for enhanced thermal stability at 37 °C and above. Additionally, we use atomic layer deposition (ALD) to coat spray-dried powders with alumina to allow for delayed release of phage from the dry formulations, and potentially protect phage against chemical damage during bone cement polymerization. Together, these findings present a strategy to formulate phages that possess thermal stability and sustained release properties for use in deep infections.
深部感染是继植入物松动后关节置换术的第二大常见并发症。抗生素载骨水泥(ALBC)和高浓度全身广谱抗生素常用于预防创伤和手术后感染。然而,临床数据并未表明 ALBC 对深部感染有效,并且长期使用抗生素会产生负面副作用。此外,多药耐药(MDR)细菌的出现迫切需要广谱抗生素的替代品。噬菌体治疗,即用噬菌体(感染细菌的病毒)来靶向致病菌,可能为对抗 MDR 细菌提供一种安全的替代方法。噬菌体治疗在深部感染中的应用需要制定策略,即在骨水泥聚合过程中稳定噬菌体免受化学和热应激,在生理温度下保持噬菌体数周或数月的活性,并允许噬菌体持续释放以对抗生长缓慢、持续存在的细菌。在这里,我们展示了针对多种细菌病原体的三种噬菌体的配方,其中包括喷雾干燥颗粒以提高在 37°C 及以上的热稳定性。此外,我们使用原子层沉积(ALD)在喷雾干燥的粉末上涂覆氧化铝,以允许从干制剂中延迟释放噬菌体,并可能在骨水泥聚合过程中保护噬菌体免受化学损伤。总之,这些发现提出了一种配方策略,使噬菌体具有热稳定性和持续释放特性,可用于深部感染。