Chlorhexidine Acetate

WAYNE, Pa., July 24, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the establishment of the Teleflex Center for Antimicrobial Protection (TCAP) as a strategic branch of its Vascular Access business unit led by Chuck Gartner, Director of Marketing - Strategic Initiatives. The Teleflex Center for Antimicrobial Protection, located in Research Triangle, North Carolina, is dedicated to reducing the spread of infections caused by multidrug-resistant organisms. Too often patients are exposed to these “superbugs” which can lead to additional complications and an increased length of stay in a hospital setting.1 Through education and partnership with professionals in infection prevention, TCAP seeks to be a resource for patients, physicians, and healthcare organizations. “Teleflex strives to deliver vascular access products that are designed to benefit both clinicians and patients by helping to reduce vascular access related complications,” said Lisa Kudlacz, President and General Manager, Teleflex Vascular. “We are proud of TCAP’s commitment to antimicrobial catheter technology and our ability to reduce the colonization of major pathogens linked to central line associated blood stream infections (CLABSI).”2 The Teleflex Center for Antimicrobial Protection aims to provide quality products, services, and education to its customers by pioneering catheter protection technology and developing innovative vascular access devices. TCAP recently sponsored an educational webinar focused on the expansion of surveillance of healthcare-acquired infections (HAI), specifically central line-associated bloodstream infections (CLABSI). That webinar can be viewed on-demand through Teleflex Academy. Teleflex, through its Arrow™ Brand of Vascular Access Products, has the only comprehensive portfolio of antimicrobial Chlorhexidine catheters designed to provide broad-spectrum protection against gram-positive, gram-negative, and fungal pathogens.2,3,4 Additionally, Arrow™ Maximal Barrier Kitting options provide protection for patients and improve procedural efficiency for clinicians.5 This portfolio of products was showcased at the Association for Professionals in Infection Control and Epidemiology (APIC) 2024 Annual Conference. During the conference, TCAP sponsored an educational Exhibitor Theater session, focused on CLABSI trends. To learn more about Arrow™ Antimicrobial Catheter and Kitting Solutions, visit our website. About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Arrowg+ard Blue, Arrowg+ard Blue Advance, Arrowg+ard Blue Plus, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are trademarks or registered trademarks of their respective owners. © 2024 Teleflex Incorporated. All rights reserved. MC-009780 References: Toor H, Farr S, Savla P, Kashyap S, Wang S, Miulli DE. Prevalence of central line-associated bloodstream infections (CLABSI) in intensive care and medical-surgical units. Cureus. 2022;14(3):e22809.doi:10.7759/cureus.22809In vitro data on file 2010: AVER-004371 and AVER-004483. No correlation between in vitro/in vivo testing methods and clinical outcomes has currently been ascertained.Maki DG, Stolz SM, Wheeler S, Mermel LA. Prevention of Central Venous Catheter-Related Bloodstream Infection With an 'Antiseptic-Impregnated Catheter: A Randomized, Controlled Trial. Annals of Internal Medicine, August 15, 1997, Vol. 127, Issue 4, pp. 257–266.Spangler D and Moss S. In-Vitro Assessment of Antimicrobial Activity of Three Commercially Available Central Venous Catheters. Poster by Arrow (Teleflex) International, Inc. Department of Applied Research. 2010-0406 v1Fenik Y, Celebi N, Wagner R, et al. Prepackaged central line kits reduce procedural mistakes during central line insertion: a randomized controlled prospective trial. BMC Medical Education. 2013;13:60. Published 2013 Apr 30. doi:10.1186/1472-6920-13-60. https://www-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/pmc/articles/PMC3645964/ Rx only Contraindications: The Arrowg+ard Blue™ and Arrowg+ard Blue Plus™ Catheters are contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs. Clinical assessment of the patient must be completed to ensure no contraindications exist. The Arrowg+ard Blue Advance™ Catheters are contraindicated in the following areas: • Patients with known hypersensitivity to chlorhexidine• In presence of device related infections• In presence of previous or current thrombosis in the intended vessel or along the catheterized vessel pathway. No correlation between in vitro/in vivo testing methods and clinical outcomes have currently been ascertained. For complete indications, contraindications, warnings, precautions, and adverse reactions, please refer to each referenced product's full package insert. Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。混悬滴眼液是一种医用眼药水，它的特点是含有未完全溶解的固体颗粒。这些颗粒在液体基质中均匀分散，使得药物能够在滴入眼睛时提供持续的释放效果。混悬滴眼液通常用于治疗需要缓释或持续药效的眼科疾病，例如某些类型的眼部炎症或青光眼。混悬滴眼液在使用前需要充分摇匀，以确保药物颗粒均匀分散。由于其含有固体成分，这类滴眼液可能在贮存过程中出现沉淀，因此摇匀是使用前的重要步骤。此外，混悬滴眼液的设计也考虑到了确保药物颗粒不会刺激眼球，以及能够安全有效地通过眼睛的天然屏障。由于其特殊的制剂和释放特性，混悬滴眼液在眼科治疗中提供了一种重要的药物给药方式，特别是在需要控制药物释放速率或增强治疗效果的情况下。下面简要列举混悬滴眼液的几个主要的研究要点：A.分散相的粒度和溶解在过去的几十年里已经有了大量的研究，证明粒径超过30-40微米的颗粒虽然在分散介质中可以稳定地存在，但可能会引起角膜擦伤并且有着较强的刺激性。目前业内普遍认为混悬滴眼液的粒度应小于10微米以尽量减少刺激。较小的颗粒具有更大的比表面积，因此根据Noyes-Whitney定律，溶解速度更快。有学者给兔子使用了平均粒径为5.75、11.5和22.0微米的0.1%地塞米松混悬液，发现随着颗粒粒径的减小，角膜和房水中的药物水平显著增加。他们提出，随着粒径大，体内溶解速度会减慢，以至于颗粒在溶解完成前就从结膜囊中被清除。因此，药物进入房水的速度和程度都会减少。正因为混悬滴眼液对颗粒的粒径上限有着严格的要求，因此在其他剂型——如混悬注射液和混悬口服液中常见的——为了控制药物释放和增强物理稳定性制成的絮凝（flocculation）状态，在混悬滴眼液中是看不到的，甚至是要严格避免的。因为颗粒的絮凝，相当于形成了大的颗粒，极大可能会造成临床用药时的刺激性。图 稳定型混悬液图 絮凝型混悬液控制粒径上限这一点并不难理解。但鲜为人知的是，将直径减小到几微米可能会导致混悬的颗粒从结膜囊中非常快速地被清除。有学者测试了同质的、放射性标记的微球在兔子前房的滞留情况，这些微球的直径分别为3微米和25微米。他们发现较小的球体消除速度更快，且随着给药量的增加，消除速度也随之增加。最后得出了结论：“除了先前认识到的要控制粒径上限降低刺激性外，混悬液粒径的下限可能也需要进行控制。”也正因为如此，FDA对于混悬滴眼液仿制药的个药指南，都严苛地要求了群体生物等效性（PBE）。其要求使用至少每批10个单位，对测试产品和参考标准（RS）产品的三批次进行体外生物等效性研究。测量参数包括D50和SPAN [(D90-D10)/D50] 基于（95%上置信界限）的生物等效性：对PSD D50和SPAN进行群体生物等效性（PBE）分析。因为有着粒径上限和下限两方面的要求，所以只有通过了PBE这样的严格的体外实验，才能证明仿制药的粒径分布不会影响到临床药效。B.沉淀的形成和再分散性；患者依从性提到混悬液，大家都会关注到它会沉淀，因此在使用前需要重新分散它们。理想的混悬液应该能通过摇晃轻松重新分散，应该能够悬浮足够长的时间以抽取准确剂量，并且应该具有理想的流动性。对于所有类型的药物的混悬液，如果无法获得持久均匀的分散，那么在药物设计是要首选形成明显的可见沉淀，以提醒患者在使用前摇晃。然而，混悬滴眼液是很难形成明显可见沉淀的。首先如前文所述，因为粒径上限的限制，无法将其制成絮凝状态加快沉降让其更加明显；其次滴眼液的剂量较小，因此沉降现象愈发不明显；再有就是包材，很多制剂产品因为避光的考虑设计成非透明的塑料瓶，因此患者甚至根本看不到颗粒的沉降。很多研究都显示，眼科患者的依从性是非常差的。有学者研究了100名成人患者的依从性，这些患者在使用1.0%的醋酸泼尼松测试混悬液前经过了适当指导。但有63%的患者即使在阅读了清晰印在容器上的说明后也根本不摇晃瓶子，这些患者给眼睛的输送量不足制剂最大浓度的三分之一。就算是摇晃了瓶子的患者，几乎半数输送的剂量都不足所需剂量的一半。目前，各国药典都对混悬滴眼液提出了沉降体积比的要求，但这个指标也只能保证药物重新分散后能有充分的时间使用。或许，在药物光敏性可以接受的情况下，尽量采用透明的塑料瓶是个好的选择。C.灭菌与保存滴眼液属于无菌制剂，这在所有官方药典中都有要求。但由于无法使用除菌过滤作为灭菌方法，所以存在一些困难。而且热压灭菌在这种剂型中也往往应当避免，因为高温可能会导致药物部分溶解，并在冷却时析出出较大的晶体，造成粒径不可预测的变化；此外，大部分助悬剂在进行热压灭菌时也会造成粘度的下降。因此，混悬滴眼液在生产上更多地考虑无菌工艺。在某些情况下，会考虑对最终产品采用辐照（γ射线）灭菌。混悬滴眼液的无菌工艺一般都较为复杂，比较常规的工艺可能是将药液的可溶性部分经过除菌过滤输送到最终的无菌罐；再将无菌原料药经过无菌隔离器投入；在无菌罐中，不溶的无菌原料经过均质搅拌均匀分散在药液中。最后在持续的搅拌过程中，药液分装在塑料瓶中。在多剂量的滴眼液一般都会添加防腐剂，混悬滴眼液也不例外。合适的防腐剂包括季铵化合物、氯丁醇、氯己定、有机汞、对羟基苯甲酸酯等。与普通的溶液型滴眼液不同的是，有的防腐剂会被悬浮的颗粒吸附，并导致其部分失活。D.晶体生长晶体生长和混悬液中的多态变化一直是制剂研究者的担忧来源。混悬液配制好后不久，或慢慢且不知不觉中晶体大小和形状发生了变化，简直就像被施了黑魔法。这样一来，无论将分散相调整到多么精确的粒径，都成了一场空。晶体结构在储存过程中可能会发生变化，导致晶体大小增加（或减少）以及混悬液特性的改变：由此引起的溶解性变化可能会反映在生物可用性的变化上。众所周知，某些药物具有形成多态体或伪多态体的特性，并且当悬浮在水介质中时，会进行较快或较慢的转变，形成新的晶体。如上图所示，同样物质，针状的（needle）晶体比起片状的（plate）的晶体，具有更大的比表面积，因而在同样的粒径下具有更高的溶解度。有研究显示，约100种类固醇中有60%左右是多态的，并形成晶体溶剂化物，其中水合物始终是最稳定的形式。如果使用不稳定的、微米化的药物多态体来制备悬浮液，那么转变为更稳定的形式将不可避免，这将导致晶体生长以及潜在的结块和聚集物的形成。晶体生长主要是由多态转变引起的：晶格能、吸湿热和不同晶体形态的溶解被指示为控制速率的因素。制剂技术的进步和仔细选择辅料，可以完全或在很大程度上避免与混悬液中的晶体生长的相关问题。在探讨混悬滴眼液的多个关键研究要点之后，我们可以得出结论：优化粒度控制和提高再分散性是提升这类药物制剂效果的核心。通过精确调整颗粒大小和形状，不仅可以减少对眼睛的刺激，还可以增强药物的生物可用性和疗效。同时，制剂的设计必须确保患者能够便捷地使用，包括简化摇晃过程和改进包装设计，以增强患者的依从性。此外，确保混悬滴眼液的无菌状态和储存稳定性是至关重要的，适当的灭菌方法和储存条件可以保护药物免受微生物污染，确保其在整个有效期内的安全性。最后，关注晶体的生长和多态变化也同样重要，因为这些因素会直接影响药物的稳定性和生物可用性。随着制剂技术的不断进步和更深入的生物等效性研究，混悬滴眼液将更好地满足临床需求，为眼科治疗提供更有效、更安全的解决方案。参考文献：Françoise Nielloud, Gilberte Marti-Mestres，《Pharmaceutical emulsions and suspensions》，2000-END-药事纵横投稿须知：稿费已上调，欢迎投稿各位朋友好，觉得本文对您有帮助，请随手点一下下方的在看，以便让你的朋友也能看到哦。