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口服固体剂型使用替代晶体内拉提尼布酸无水形式:药物,生物等效和临床观点
Congmei Ming1, Zhi Liu1, Qiong Wang1
1Convalife Pharmaceuticals, Shanghai, China.
Biomedical chromatography : BMC
|August 21, 2024
概括
涅拉提尼布是一种HER2阳性乳腺癌治疗方法,是以一种新的无水形式开发的. 这种稳定的涅拉替尼酸无水形式与现有的单水合物产品表现出生物等价性.
科学领域:
- 在瘤学瘤学.
- 制药科学 制药科学
- 药物开发 药物开发
背景情况:
- 涅拉丁尼是一种不可逆转的泛人类表皮生长因子受体 (HER) 抑制剂,对治疗HER2阳性乳腺癌至关重要.
- 目前在市场上销售的剂量形式NERLYNX使用了专利的晶体内拉替尼酸单酸盐形式.
- 产品开发和监管批准需要关于替代固态形式的可靠数据.
研究的目的:
- 描述一种稳定的晶体内拉提尼布马莱酸无水形式的产品开发过程.
- 介绍稳定性和生物等价性 (BE) 研究的结果,比较无水形式与现有的单形式.
- 讨论内拉替尼产品临床研究期间观察到的不良影响.
主要方法:
- 开发和表征稳定的晶体内拉提尼布马莱酸无水形式.
- 在各种条件下进行全面的稳定性研究.
- 生物等价性研究,将新无水形式与已确定的单水化合物产品进行比较.
- 从临床试验数据中分析不良事件.
主要成果:
- 成功开发了一种稳定的晶体内拉提尼布马莱酸无水形式.
- 无水形式符合稳定性要求.
- 生物等价性研究证实了无水和单水化合物形式之间的可比药理学特征.
- 记录和分析了不良影响.
结论:
- 稳定的晶体内拉替尼酸无水形式是治疗HER2阳性乳腺癌的可行替代方案.
- 生物等效数据支持无水和单水化合物形式的可互换性.
- 进一步的临床评估和无水形式的监管提交是有必要的.
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