{"title":"基于各种理化参数的欧洲 37 种泪液替代品概览。","authors":"Adrien Paschier, Aurélie Manuelli, Laure Chauchat, Morgane Legall, Hayette Rebika, Marwan Sahyoun, Camille Guerin","doi":"10.1007/s40123-024-01023-9","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Dry eye disease (DED) is one of the most prevalent eye conditions worldwide, with artificial tears serving as a primary treatment option. Despite their wide availability on the European market, there is a lack of established classifications based on their physicochemical properties. The aim of our study was therefore (i) to develop an analytical method that measures the concentration and the molecular weight (MW) of the hyaluronic acid (HA) in commercialized products, and (ii) to propose an overview based on their various physicochemical parameters.</p><p><strong>Methods: </strong>The intrinsic viscosity and MW of the HA, as well as osmolarity, pH, rheological profile, and viscosity, were measured or determined. A specific method was developed to measure the average intrinsic viscosity and HA content using a liquid size-exclusion chromatography system. The MW was determined using the Mark-Houwink equation.</p><p><strong>Results: </strong>Thirty-seven products commercialized in Europe were analyzed, with 21 of them containing HA. The HA MW was lowest (300 kDa) for Thealose<sup>®</sup>, Thealoz Duo<sup>®</sup> Gel, and Hyabak<sup>®</sup>, and highest (1300 kDa) for Vismed<sup>®</sup> Multi, Vismed<sup>®</sup> Gel, and Neovis<sup>®</sup> Gel. The pH values varied between 5.94 for Treovis<sup>®</sup> and 8.06 for Systane<sup>®</sup> Ultra. Osmolarity ranged between 148 mOsm/L and 325 mOsm/L for Neovis<sup>®</sup> and Treovis<sup>®</sup>, respectively. Viscosity was highly variable, ranging from 0.38 mPas·s for Hylolipid<sup>®</sup> to 337.47 mPas·s for Thealoz<sup>®</sup> Duo Gel. Finally, rheological profile analysis revealed different shear-thinning behaviors.</p><p><strong>Conclusion: </strong>While the perfect eye drop does not exist, a multitude of options are available to choose from. This study improves our understanding of the major tear substitutes available on the European market based on several physicochemical properties. A better understanding and awareness of these parameters is crucial in order to offer the best treatment for patients with DED.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":"2799-2812"},"PeriodicalIF":2.6000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408415/pdf/","citationCount":"0","resultStr":"{\"title\":\"Overview of 37 Tear Substitutes in Europe Based on Various Physicochemical Parameters.\",\"authors\":\"Adrien Paschier, Aurélie Manuelli, Laure Chauchat, Morgane Legall, Hayette Rebika, Marwan Sahyoun, Camille Guerin\",\"doi\":\"10.1007/s40123-024-01023-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Dry eye disease (DED) is one of the most prevalent eye conditions worldwide, with artificial tears serving as a primary treatment option. Despite their wide availability on the European market, there is a lack of established classifications based on their physicochemical properties. The aim of our study was therefore (i) to develop an analytical method that measures the concentration and the molecular weight (MW) of the hyaluronic acid (HA) in commercialized products, and (ii) to propose an overview based on their various physicochemical parameters.</p><p><strong>Methods: </strong>The intrinsic viscosity and MW of the HA, as well as osmolarity, pH, rheological profile, and viscosity, were measured or determined. A specific method was developed to measure the average intrinsic viscosity and HA content using a liquid size-exclusion chromatography system. The MW was determined using the Mark-Houwink equation.</p><p><strong>Results: </strong>Thirty-seven products commercialized in Europe were analyzed, with 21 of them containing HA. The HA MW was lowest (300 kDa) for Thealose<sup>®</sup>, Thealoz Duo<sup>®</sup> Gel, and Hyabak<sup>®</sup>, and highest (1300 kDa) for Vismed<sup>®</sup> Multi, Vismed<sup>®</sup> Gel, and Neovis<sup>®</sup> Gel. The pH values varied between 5.94 for Treovis<sup>®</sup> and 8.06 for Systane<sup>®</sup> Ultra. Osmolarity ranged between 148 mOsm/L and 325 mOsm/L for Neovis<sup>®</sup> and Treovis<sup>®</sup>, respectively. Viscosity was highly variable, ranging from 0.38 mPas·s for Hylolipid<sup>®</sup> to 337.47 mPas·s for Thealoz<sup>®</sup> Duo Gel. Finally, rheological profile analysis revealed different shear-thinning behaviors.</p><p><strong>Conclusion: </strong>While the perfect eye drop does not exist, a multitude of options are available to choose from. This study improves our understanding of the major tear substitutes available on the European market based on several physicochemical properties. 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引用次数: 0
摘要
简介干眼症（DED）是全球最常见的眼部疾病之一，人工泪液是主要的治疗方法。尽管人工泪液在欧洲市场上广泛供应，但缺乏基于其物理化学特性的既定分类。因此，我们的研究目的是：(i) 开发一种分析方法，测量商业化产品中透明质酸（HA）的浓度和分子量（MW）；(ii) 根据其各种理化参数提出一个概述：方法：测量或确定透明质酸的固有粘度和分子量，以及渗透压、pH 值、流变曲线和粘度。开发了一种特定方法，使用液体尺寸排阻色谱系统测量平均固有粘度和 HA 含量。使用 Mark-Houwink 公式确定了 MW：结果：分析了欧洲 37 种商业化产品，其中 21 种含有 HA。Thealose®、Thealoz Duo® Gel 和 Hyabak® 的 HA 最大分子量最低（300 kDa），Vismed® Multi、Vismed® Gel 和 Neovis® Gel 的 HA 最大分子量最高（1300 kDa）。Treovis® 和 Systane® Ultra 的 pH 值分别为 5.94 和 8.06。Neovis® 和 Treovis® 的渗透压分别在 148 mOsm/L 和 325 mOsm/L 之间。粘度变化很大，从 Hylolipid® 的 0.38 mPas-s 到 Thealoz® Duo Gel 的 337.47 mPas-s。最后，流变曲线分析显示了不同的剪切稀化行为：结论：虽然完美的滴眼液并不存在，但有多种选择可供选择。这项研究根据几种物理化学特性加深了我们对欧洲市场上主要泪液替代品的了解。更好地了解和认识这些参数对于为 DED 患者提供最佳治疗至关重要。
Overview of 37 Tear Substitutes in Europe Based on Various Physicochemical Parameters.
Introduction: Dry eye disease (DED) is one of the most prevalent eye conditions worldwide, with artificial tears serving as a primary treatment option. Despite their wide availability on the European market, there is a lack of established classifications based on their physicochemical properties. The aim of our study was therefore (i) to develop an analytical method that measures the concentration and the molecular weight (MW) of the hyaluronic acid (HA) in commercialized products, and (ii) to propose an overview based on their various physicochemical parameters.
Methods: The intrinsic viscosity and MW of the HA, as well as osmolarity, pH, rheological profile, and viscosity, were measured or determined. A specific method was developed to measure the average intrinsic viscosity and HA content using a liquid size-exclusion chromatography system. The MW was determined using the Mark-Houwink equation.
Results: Thirty-seven products commercialized in Europe were analyzed, with 21 of them containing HA. The HA MW was lowest (300 kDa) for Thealose®, Thealoz Duo® Gel, and Hyabak®, and highest (1300 kDa) for Vismed® Multi, Vismed® Gel, and Neovis® Gel. The pH values varied between 5.94 for Treovis® and 8.06 for Systane® Ultra. Osmolarity ranged between 148 mOsm/L and 325 mOsm/L for Neovis® and Treovis®, respectively. Viscosity was highly variable, ranging from 0.38 mPas·s for Hylolipid® to 337.47 mPas·s for Thealoz® Duo Gel. Finally, rheological profile analysis revealed different shear-thinning behaviors.
Conclusion: While the perfect eye drop does not exist, a multitude of options are available to choose from. This study improves our understanding of the major tear substitutes available on the European market based on several physicochemical properties. A better understanding and awareness of these parameters is crucial in order to offer the best treatment for patients with DED.
期刊介绍：
Aims and Scope
Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
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The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies.
Open Access
All articles published by Ophthalmology and Therapy are open access.
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The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
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Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis.
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Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor.
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