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Halobutyl for pharmaceutical stoppers and seals

机译:卤丁基胶,用于医药瓶塞和密封

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Exxon halobutyl polymers are used worldwide for pharmaceutical stoppers and seals. The intrinsic high gas and moisture barrier, chemical inertness and cleanliness (low level of additives and impurities) of Exxon Halobutyl Polymers make them the natural choice for pharmaceutical stoppers and seals applications. Pharmaceutical stoppers and seals are currently used in a wide range of applications including injection vials, infusion bottles, pre-filled syringes, medical devices, freeze-dried product containers, blood and biological sample collection tubes etc. The advance of drug development (e.g. new generations of antibiotics) and health-care standard have led to ever higher cleanliness requirement of the packaging material that comes into contact with the medicine during its storage. For drug manufacturers to approve the usage of any stopper it must pass a series of stringent tests, depending on the packaged drug. Due to the fact that Chlorobutyl and Bromobutyl polymer can be cured using low amount of 'clean' curative, stoppers made using Halobutyl enjoy a high degree of commercial success. However, new generation of antibiotics as well as new industry standard (e.g. China) has challenged stopper manufacturers to pursue even higher degree of cleanliness. In this presentation we will share with you some of our recent efforts to further improve the drug compatibility performance of pharmaceutical stoppers made using Exxon halobutyl for meeting the very stringent drug turbidity standard of China. The paper also discussed about formation mechanism and factors that affect drug turbidity. The importance of polymer type and curative used for achieving good drug compatibility will be highlighted by actual drug turbidity study of various stoppers with Pioneer #5 antibiotic.
机译:埃克森公司的卤化丁基聚合物在世界范围内被用作药物塞子和密封件。埃克森卤代丁基聚合物固有的高气体和湿气阻隔性,化学惰性和清洁度(低含量的添加剂和杂质)使其成为制药塞和密封应用的自然选择。药物瓶塞和密封件目前广泛用于各种应用中,包括注射瓶,输液瓶,预填充注射器,医疗设备,冻干产品容器,血液和生物样品收集管等。药物开发的进步(例如,新的新一代的抗生素)和保健标准已导致对在药物存储过程中接触到的包装材料的清洁度提出了更高的要求。为了使药品制造商批准使用任何塞子,必须根据包装的药品通过一系列严格的测试。由于可以使用少量的“清洁”固化剂来固化氯丁基和溴化丁基聚合物,因此使用卤化丁基橡胶制成的塞子在商业上获得了很高的成功。但是,新一代的抗生素以及新的行业标准(例如中国)都向塞子制造商提出了更高的清洁度要求。在本演讲中,我们将与您分享我们最近在进一步改善使用埃克森卤代丁基橡胶制成的药物塞的药物相容性性能方面所做的一些努力,以达到中国非常严格的药物浊度标准。本文还讨论了形成机理和影响药物浊度的因素。通过对使用先锋5号抗生素的各种塞子进行的实际药物浊度研究,将突出显示聚合物类型和固化剂对实现良好药物相容性的重要性。

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