Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes
{"title":"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。","authors":"Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes","doi":"10.4155/tde-2023-0029","DOIUrl":null,"url":null,"abstract":"<p><p><b>Aim:</b> This study characterized <i>ex vivo</i> release of ketotifen from etafilcon A contact lenses worn over 5 h. <b>Materials & methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>","PeriodicalId":22959,"journal":{"name":"Therapeutic delivery","volume":"14 7","pages":"407-417"},"PeriodicalIF":3.0000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"<i>Ex vivo</i> analysis of ketotifen content in an antihistamine-eluting contact lens worn up to 5 hours.\",\"authors\":\"Brian Pall, Shivkumar Mahadevan, Azaam Alli, Frank Yi, Paul Gomes\",\"doi\":\"10.4155/tde-2023-0029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Aim:</b> This study characterized <i>ex vivo</i> release of ketotifen from etafilcon A contact lenses worn over 5 h. <b>Materials & methods:</b> 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. <b>Results:</b> 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. <b>Conclusion:</b> 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.</p>\",\"PeriodicalId\":22959,\"journal\":{\"name\":\"Therapeutic delivery\",\"volume\":\"14 7\",\"pages\":\"407-417\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic delivery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.4155/tde-2023-0029\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic delivery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4155/tde-2023-0029","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Ex vivo analysis of ketotifen content in an antihistamine-eluting contact lens worn up to 5 hours.
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.
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.