Ex vivo analysis of ketotifen content in an antihistamine-eluting contact lens worn up to 5 hours.

IF 3 Q2 PHARMACOLOGY & PHARMACY Therapeutic delivery Pub Date : 2023-07-01 DOI:10.4155/tde-2023-0029
Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes
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Abstract

Aim: This study characterized ex vivo release of ketotifen from etafilcon A contact lenses worn over 5 h. Materials & methods: 14 participants, 21 to 59 years, wore lenses with 19 μg ketotifen over 8 visits, for 1 min to 5 h. Residual ketotifen was measured using high-performance liquid chromatography (HPLC) compared with unworn lenses from the same lots to determine percent ketotifen remaining. Results: Residual ketotifen ranged from 16.19 μg ± 0.44 (84.1%) [1 minute] to 0.20 μg ± 0.07 (1.1%) [5 h]. No adverse events or clinically significant biomicroscopy changes were observed. Conclusion: The ketotifen-releasing etafilcon A lenses were well-tolerated with an acceptable safety profile in the population studied. The release of ketotifen from study lenses over 5 h was consistent with a diffusion-controlled system.

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佩戴5小时的抗组胺洗脱隐形眼镜中酮替芬含量的体外分析。
目的:本研究表征了酮替芬在依他非康A隐形眼镜5小时内的体外释放。材料与方法:14名年龄在21岁至59岁之间的参与者,佩戴含19 μg酮替芬的隐形眼镜8次,持续1分钟至5小时。使用高效液相色谱(HPLC)测量酮替芬残留量,并与同批次未佩戴的隐形眼镜进行比较,以确定酮替芬残留量的百分比。结果:酮替芬残留范围为16.19 μg±0.44 (84.1%)[1 min] ~ 0.20 μg±0.07 (1.1%)[5 h]。未观察到不良事件或临床显著的生物显微镜变化。结论:在研究人群中,释放酮替芬的依他非康A透镜耐受性良好,具有可接受的安全性。酮替芬在5小时内从研究透镜中释放符合扩散控制系统。
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来源期刊
Therapeutic delivery
Therapeutic delivery PHARMACOLOGY & PHARMACY-
CiteScore
5.50
自引率
0.00%
发文量
25
期刊介绍: Delivering therapeutics in a way that is right for the patient - safe, painless, reliable, targeted, efficient and cost effective - is the fundamental aim of scientists working in this area. Correspondingly, this evolving field has already yielded a diversity of delivery methods, including injectors, controlled release formulations, drug eluting implants and transdermal patches. Rapid technological advances and the desire to improve the efficacy and safety profile of existing medications by specific targeting to the site of action, combined with the drive to improve patient compliance, continue to fuel rapid research progress. Furthermore, the emergence of cell-based therapeutics and biopharmaceuticals such as proteins, peptides and nucleotides presents scientists with new and exciting challenges for the application of therapeutic delivery science and technology. Successful delivery strategies increasingly rely upon collaboration across a diversity of fields, including biology, chemistry, pharmacology, nanotechnology, physiology, materials science and engineering. Therapeutic Delivery recognizes the importance of this diverse research platform and encourages the publication of articles that reflect the highly interdisciplinary nature of the field. In a highly competitive industry, Therapeutic Delivery provides the busy researcher with a forum for the rapid publication of original research and critical reviews of all the latest relevant and significant developments, and focuses on how the technological, pharmacological, clinical and physiological aspects come together to successfully deliver modern therapeutics to patients. The journal delivers this essential information in concise, at-a-glance article formats that are readily accessible to the full spectrum of therapeutic delivery researchers.
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