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Inhalable Antibiotics Manufactured Through Use of Near-Critical or Supercritical Fluids

机译:通过使用近临界或超临界流体生产的可吸入抗生素

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The development of unit-dose, inhalable, antibiotic microparticles for use in primary and combined therapy approaches to treating tuberculosis (TB), multi-drug-resistant (MDR-TB), and extensively drug-resistant TB is explored using the gentle drying process of Carbon-dioxide Assisted Nebulization with a Bubble Dryer (CAN-BD). The microparticles produced using this method contain capreomycin, kanamycin, and isoniazid, respectively, imbedded in L-leucine. Antibiotics were developed into inhalable antibiotic formulations for their utility in both first line and second line antibiotic treatment regimens. Capreomycin and kanamycin are typically administered by injection making them desirable candidates for the development of a needle-free delivery system that addresses the Grand Challenges in Global Health Initiative #3. In response to this challenge, unit-dose packaging that preserves powder properties by protecting them from moisture, oxidants, and UV exposure, and a low cost “active” dry powder inhaler, the PuffHaler, were developed and used as a prototype device, in addition to the Aerolizer, to disperse the microparticle antibiotic formulations. Antibiotic formulations show yields above 50% in small-scale powder production by CAN-BD. Capreomycin and kanamycin show improved powder yields in scale up experiments. The particle properties were characterized using scanning electron microscopy, Karl Fischer moisture analysis, Anderson Cascade Impaction studies, and X-ray diffraction. The inhalable antibiotic formulations are within a respirable size range (1-5 μm), and have less than 3% residual moisture. Unit-dose dry powder antibiotics have the potential to provide easy-to-use, stable products with improved safety profiles.
机译:通过温和的干燥工艺,探索了用于单位剂量,可吸入的抗生素微粒的开发,该微粒可用于治疗结核病(TB),多药耐药性(MDR-TB)和广泛耐药性结核病的主要和联合疗法气泡干燥器(CAN-BD)辅助二氧化碳辅助雾化的原理使用此方法产生的微粒分别包含嵌入L-亮氨酸的辣椒素,卡那霉素和异烟肼。抗生素被开发成可吸入的抗生素制剂,以用于第一线和第二线抗生素治疗方案。卡普霉素和卡那霉素通常通过注射给药,使其成为开发无针给药系统的理想候选药物,以解决全球卫生倡议#3的巨大挑战。为应对这一挑战,开发了单位剂量包装,该产品通过保护粉末免受潮气,氧化剂和紫外线照射而保持粉末特性,并开发了低成本的“活性”干粉吸入器PuffHaler,并将其用作原型除雾化器外,该装置还用于分散微粒抗生素制剂。抗生素制剂在CAN-BD的小规模粉末生产中显示出超过50%的产率。在放大实验中,卡普霉素和卡那霉素显示出改善的粉末产量。使用扫描电子显微镜,Karl Fischer水分分析,Anderson级联碰撞研究和X射线衍射对颗粒性质进行表征。可吸入的抗生素制剂在可吸入的大小范围内(1-5微米),并且残留水分少于3%。单位剂量的干粉抗生素具有提供易于使用,稳定的产品并提高安全性的潜力。

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