胰腺酶制剂pH依赖的可用性在体外比较的研究
Amy Todd1, Emma Bennett-Huntley1, Jonas Rosendahl2
1Viatris/Mylan Pharma UK Ltd., Sandwich CT13 9ND, UK.
Pharmaceuticals (Basel, Switzerland)
|May 25, 2024
概括
胰腺酶制剂 (PEP) 在颗粒大小和酶活性方面表现出显著的差异. 胰腺替代疗法产品的这些差异表明互换性较差,标签声明与实际性能之间存在潜在的差异.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 生物化学 生物化学
背景情况:
- 胰腺内分泌功能不充分导致消化不良,用胰腺酶替代疗法 (PERT) 治疗.
- 现有的PERT配方在物理性质和酶释放方面表现出变化,影响剂量一致性和产品可互换性.
研究的目的:
- 为了比较德国各种胰腺酶制剂 (PEP) 的粒子几何,大小和酶活性.
- 在实验室中模拟生理条件下评估PEP酶活性.
- 评估不同PEP产品之间互换性差的潜在原因.
主要方法:
- 对25种不同的PEP产品的颗粒大小和数量的分析.
- 使用标准基质 (橄油,粉,素) 测量脂酶,粉酶和蛋白酶活动.
- 在体外模拟胃 (pH1,4,5) 和十二指肠 (pH6) 条件,以评估酶释放动力学.
主要成果:
- 在测试的PEP中观察到物理性质和酶释放动态的显著差异.
- 大多数产品的脂酶活性超过了标签声明,有些产品的活性超过了148%.
- 实验室检测结果表明PEP性能存在相当大的变化.
结论:
- 胰腺酶制剂在物理特征和酶释放方面存在相当大的产品间变异性.
- 在标签声明和体外酶活性之间观察到的差异表明PEP可互换性存在潜在问题.
- 医疗保健提供者和患者应被告知PEP疗效的潜在变化.
相关概念视频
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