全球的安全赋形剂需求正在增长

当今的注射剂产业正在迅速发展。例如,在疫苗领域,政府组织正在世界各地推出越来越多的计划,以遏制(传染性)疾病日益猖獗的情况。事实上,作为疫苗和其他注射剂的安全载体,对赋形剂的需求比以往任何时候都要高 (Kaddar, 2013 年)。这种趋势促使赋形剂生产企业为患者提供最安全的产品。由于明胶被广泛用作药物稳定剂和赋形剂,罗赛洛的 X-Pure 系列明胶可最大程度地保证患者安全。

The multiple benefits of highly purified pharmaceutical gelatins in parenteral applications - including vaccines

As a biomaterial of choice, gelatin is widely recognized for its use in parenteral applications.

Highly biocompatible, purified pharmaceutical gelatin helps provide drug protection, offers superior drug loading rates, and great flexibility in the control of drug release. It helps stabilize vaccines and other formulations and minimizes side reactions while ensuring patient safety. These are just few examples of the many benefits provided by purified gelatins.

Read our white paper which explores these various advantages and describes how X-Pure® extra purified GMP quality gelatins can help realize superior parenteral formulations.

X-Pure Gelatin for vaccines

Pharmaceutical gelatin is a key excipient used in many vaccine formulations. It generally offers an effective strategy to improve stability of lyophilized products and is a preferred stabilizer in many vaccines. Well-known examples include Fluenz Tetra (Astra Zeneca), MMR-II and MMR VaxPro (Merck), VariVax (Merck), YF-Vax (Sanofi) and Zostavax (Merck). In the case of Fluenz, the formulation using hydrolyzed gelatin achieved significantly superior stability over a large number of alternative stabilizers evaluated.

X-Pure is ideally suited for use in such applications where lyophilization stability is required as it is also available in a hydrolyzed and non-gelling form, has well controlled endotoxin levels below 10 EU/g, and ensured batch to batch consistency.

We can help you in your vaccine development, also for COVID-19. 

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X-Pure® 10 HGP:比以往任何时候都更安全

我们用于注射剂的赋形剂 X-Pure® 10 HGP(猪来源胶原蛋白肽)是目前市场上最纯的胶原蛋白肽。通过经过验证的工艺进行纯化,它还具有质量一致性的优势。

患者受益

  • 作为市场上首款内毒素水平低于10 EU/g甚至低于 LAL 检测限值的猪源胶原蛋白肽,其安全性无与伦比
  • 可生物降解,可完全被吸收
  • 一种天然来源的物质,人体对其具有良好的耐受性和生物相容性

生产优势

  • 采用经过验证的工艺,由罗赛洛纯化
  • 最高的质量一致性
  • 美国食品和药品管理局 (FDA) 认定为“一般公认安全 ”(GRAS),并符合美国和欧洲药典要求
  • 同时适用于人类和动物

了解更多有关我们质量第一为宗旨的验证方法

 

了解X-Pure如何为再生医学和止血药做出贡献