传统与机械IVIVC:在建立扩展释放配方溶解安全空间的比较研究
Sivacharan Kollipara1, Tausif Ahmed2, Mahendra Chougule2
1Department of Pharmacy, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Andhra Pradesh, 522302, India.
AAPS PharmSciTech
|May 28, 2024
概括
与传统IVIVC相比,机械化体外-体内相关性 (IVIVC) 为延长释放药物提供了更广泛的溶解安全空间. 这种方法结合了生理因素,可能减少对临床研究的需求.
科学领域:
- 制药科学 制药科学
- 生物制药生物制药公司
- 药物运输 药物运输 药物运输
背景情况:
- 在体外-体内相关性 (IVIVC) 对于延长释放的口服剂型至关重要,有助于监管提交和过程变化.
- 传统的IVIVC被广泛使用,但结合生理方面的机械IVIVC提供了一个有吸引力的替代方案.
- 美国FDA的指导已经支持使用IVIVC超过二十年的各种监管应用.
研究的目的:
- 为了比较评估机械和传统的IVIVC,以建立溶解安全空间.
- 评估机械IVIVC在药物开发中的灵活性和潜力.
- 用divalproex和tofacitinib延长释放配方作为案例研究.
主要方法:
- 使用Phoenix软件建立了传统的IVIVC.
- 机械IVIVC是使用Gastroplus生理基础生物制药模型 (PBBM) 开发的.
- 使用韦布尔函数生成虚拟溶解配置文件,并在内部和外部验证.
主要成果:
- 与传统IVIVC相比,机械IVIVC产生了更大的溶解安全空间.
- 该研究使用绝对误差和T / R比率方法成功建立了安全空间.
- 虚拟溶解档案被整合到两个IVIVC模型中进行分析.
结论:
- 机制IVIVC通过整合生理学方面提供了更灵活的方法.
- 机械IVIVC显示了建立更广泛溶解安全空间的更大潜力.
- 这些发现表明,机械IVIVC可以提高避免延长释放配方临床研究的能力.
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