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新品发布 | 德特威勒推出 NeoFlex™ 活塞,适用于大容量生物制剂的自动注射器和可穿戴式注射器

新品发布 | 德特威勒推出 NeoFlex™ 活塞,适用于大容量生物制剂的自动注射器和可穿戴式注射器

2024年10月,德特威勒 (Datwyler) 宣布NeoFlex™ 涂膜活塞系列再添新成员:适用于大容量自动式注射器和可穿戴式注射器尺寸要求的新活塞产品。

 

在意大利米兰举行的CPHI Worldwide展会期间,公司在其展位上(20B48)首次展示了适用于10ml预灌封注射器以及适用于10ml可穿戴卡式瓶注射器的NeoFlex™活塞。新款活塞的设计满足最高的品质和安全标准,可以安全应对通过这些给药装置递送大容量注射剂的独特挑战。

随着人们越来越倾向于居家治疗慢性病,自动式注射器和可穿戴式注射器的使用量正在增加。这些产品可以让患者使用大容量皮下注射生物制剂 (LVSC) 对某些癌症以及免疫系统、神经系统和心血管的疾病进行自我给药。通常,必须施用的注射剂是高浓度和高粘度的配方,易受杂质影响。此外,这些药物的制造和分销成本昂贵,因此对每个组件的要求都非常严格,以更好地保障患者安全,杜绝产品污染,以致召回。

 

德特威勒医药健康的首席执行官 Dirk Borghs 表示:“如果你曾目睹至爱之人与癌症作抗争,你就会知道时间是那么的宝贵,而患者掌握如何利用这些时间的能力也同样珍贵。自动式注射器和可穿戴式注射器将使数百万患者在治疗中获得更多的时间掌控权。这意味着医药健康领域的巨大变革,但这一切都依赖于这些设备的质量和性能。每个组件都至关重要。”

 

德特威勒的新款活塞具有 NeoFlex™ 涂膜活塞系列的所有优点,非常适合用于自动式和可穿戴式注射器。为了确保大分子药物的稳定性和安全性,NeoFlex 活塞表面完全覆盖了一层非氟表面活性剂等级的氟聚合物喷涂层,可防止橡胶微粒的脱落,并最大限度地减少可提取物和浸出物的降解。NeoFlex™ 活塞在德特威勒的 FirstLine® 工厂生产,以确保最高水平的质量保证和风险控制,采用洁净室环境、自动化生产单元和 100% 视觉检测。

 

NeoFlex™ 活塞本身具有润滑性,无需使用硅油即可确保预灌封注射器或卡式瓶玻璃筒内部的顺畅操作,同时支持与复杂制剂的兼容性。这一特性对于有效递送高敏感度、高粘度的生物制剂尤为重要。

 

此外,处理高粘度产品需要仔细选择加工技术,例如泵的选择,以最大限度地降低成本并确保产品质量的一致性。德特威勒与领先的制药公司和给药系统制造商密切合作,设计出了新款的 NeoFlex™ 活塞,使其在填充具有最小气头和受控活塞压缩的大容量卡式瓶药筒时可以实现卓越的加工性能。这种合作对有效的商业化至关重要。

 

这两款适用于10ml预灌封注射器和10ml可穿戴卡式瓶的活塞加入了不断扩展的德特威勒NeoFlex™ 家族。目前NeoFlex™ 涂膜活塞系列包含适用于0.5ml、1ml、2.25ml、10ml预灌封注射器的活塞,以及适用于3ml、10ml卡式瓶的活塞。更多创新即将问世。

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