根据EMA和FDA的监管框架,对具有质量和数量差异的乳进行同等价值评估
Paola Volontè1, Umberto M Musazzi1, Luca Arnaboldi2
1Department of Pharmaceutical Sciences, Università degli Studi di Milano, via G. Colombo 71, Milan 20133, Italy.
概括
监管机构接受基于风湿学和体外释放的局部产品等价性,绕过临床研究. 这项研究表明,这些方法还可以管理半固体药物产品的营销后成分变化.
科学领域:
- 制药科学 制药科学
- 药物产品等价 药物产品等价
- 局部药物输送 局部药物输送
背景情况:
- 欧洲药物管理局 (EMA) 和美国食品和药物管理局 (FDA) 正在更新局部药物产品质量和同等性评估指南.
- 目前的指导方针接受基于风湿性质和体外药物释放 (k) 和皮肤透流量 (J) 值的类似局部配方的等价性,避免临床试验.
- 这些评估主要用于开发通用局部产品,并支持营销后的变化.
研究的目的:
- 对复杂的半固体制剂中的组成变异应用已确定的等价性评估方法 (风湿学,体外释放) 的可行性进行评估.
- 确定这些方法是否可以支持超越简单产品副本的营销后变化.
主要方法:
- 使用Ibuprofen (IB) 1%和10%的乳作为模型配方.
- 引入了两种类型的配方变化:添加湿剂 (小变化) 和取代乳化系统 (主要变化).
- 在配方变化之前和之后,比较了质性质,体外药物释放常数 (k) 和皮肤透流量 (J) 值.
主要成果:
- 配方的变化对1%的IB奶油产生了重大影响,导致风湿学数据和J值的等价性失败.
- 在10%的IB度下,布洛芬晶体的存在掩盖了风湿学差异,并最大限度地提高了热力学活性.
- 这导致10%IB配方的J值重叠,表明尽管成分发生了变化,但它们是相当的.
结论:
- 通常用于通用产品开发的风湿学和体外药物透性研究的组合可以扩展到管理涉及产品成分的营销后变化.
- 半固体局部产品中的高药物度 (10% IB) 似乎稳定了等价性参数,使它们对某些配方变化具有强度.
- 这种方法为监管机构提供了一种潜在的策略,可以评估局部药品中微小和重大成分变化的影响,而不需要临床研究.
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