An extended release ciprofloxacin/dexamethasone hydrogel for otitis media.
An extended release ciprofloxacin/dexamethasone hydrogel for otitis media.
复制标题
扩展释放环丙沙星/地塞米松水凝胶用于中耳炎。
DOI：
10.1016/j.ijporl.2020.110311
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发表时间：
2020-11
影响因子：
1.5
通讯作者：
Pierstorff, Erik
中科院分区：
文献类型：
--
作者：
Ku, Matthew;Cheung, Shirley;Slattery, William;Pierstorff, Erik
中耳炎和相关的耳炎是鼓膜造孔管插入后常见的并发症;鼓膜造孔管插入是美国儿童最常见的耳科手术。目前的治疗方法包括向受影响的耳朵施用抗生素或抗生素/抗炎组合滴剂。一些研究表明，使用抗生素/抗炎组合产品比单独使用抗生素更有效。然而，通过鼓膜造口管给药任何滴剂在儿童中是非常困难的，并且患者依从性可能是一个问题。我们的小组已经开发了一种新的组合药物/水凝胶制剂，用于治疗中耳炎/耳炎，其在2-3周的时间内释放环丙沙星和地塞米松。这有可能提供优于临床上使用的当前治疗的显著优势。药物从组合水凝胶中的释放在体外在所需的时间范围内进行验证，并且释放的药物的活性通过测定进行监测以确认在整个溶解期内保留全部活性。通过豚鼠体内耳毒性研究（包括听力测试、大体显微镜检查和细胞耳蜗图分析）评价了环丙沙星/地塞米松水凝胶及其非活性辅料的安全性。两种药物的缓释在体外被证明，并保留了抗生素/抗炎活性。水凝胶组分及其赋形剂在动物中未引起不良反应，证明了水凝胶组合在体内的安全性。所提出的研究为能够在期望的时间段内安全地释放活性药剂的组合的延长释放中耳水凝胶制剂奠定了基础。这将比目前临床上用于治疗与鼓膜造口管插入相关的中耳炎/耳炎的治疗剂更有利。
Otitis media and associated otorrhea are frequent complications following tympanostomy tube insertion; the most common otologic procedure performed in children in the United States. Current treatments include the administration of antibiotic or antibiotic/anti-inflammatory combination drops to the affected ear. Several studies have demonstrated that using an antibiotic/anti-inflammatory combination product is more effective than the use of antibiotics alone. However, administration of any drops through the tympanostomy tube is very difficult in children, and patient compliance can be an issue. Our group has developed a novel combination drug/hydrogel formulation for the treatment of otitis media/otorrhea that releases both ciprofloxacin and dexamethasone over a 2–3 week period. This has the potential to offer significant advantages over current treatments in use in the clinic. The release of drugs from the combination hydrogel was validated in vitro over the desired time frame and the activity of the released drugs was monitored via assays to confirm retention of full activity throughout the dissolution period. The safety of the ciprofloxacin/dexamethasone hydrogel and its inactive excipients was evaluated through in vivo otic toxicity studies in guinea pigs, including hearing tests, gross microscopy, and cytocochleogram analysis. Extended release of both drugs was demonstrated in vitro and antibiotic/anti-inflammatory activities were retained. The hydrogel components and its excipients did not cause adverse reactions in animals, demonstrating safety of the hydrogel combination in vivo. The studies presented lay the groundwork for extended release middle ear hydrogel formulations that are capable of safely releasing combinations of active pharmaceutical agents over a desired period of time. This would be more advantageous than therapeutics that are currently used in the clinic for the treatment of otitis media/otorrhea associated with tympanostomy tube insertion.
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影响因子：
8
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通讯作者：
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