面向 in vitro - in vivo 对应模型,以在现场形成药物植入物
Xiaoyi Wang1, Mckenzie Roy1, Ruifeng Wang1
1Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA.
概括
开发用于在位形成植入物的体外-体内相关性 (IVIVC) 是具有挑战性的. 这项研究优化了体外方法,以实现RISPERIDONE植入物的A级IVIVC,成功验证了该模型.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 生物制药生物制药公司
背景情况:
- 在体外-体内相关性 (IVIVC) 对于预测药物性能和减少临床试验至关重要.
- 开发用于in situ形成植入物的IVIVC是困难的,因为在体外和体内不同的药物释放概况.
- 这种复杂性源于这些剂型固有的独特的药物释放机制.
研究的目的:
- 确定在体外释放测试方法的关键属性,这些属性会影响体外形成植入物中的药物释放.
- 优化体外释放方法,以建立A级IVIVC,用于risperidone in situ形成植入物.
- 根据体外数据提高药物产品性能的可预测性.
主要方法:
- 作为一个模型系统,研究了risperidone in situ形成植入物.
- 采用了使用特龙适配器和GF/F膜或玻璃幻灯片适配器的新型溶解方法.
- 评估了表面与体积比,吸水量,相分离率和机械压力对药物释放的影响.
主要成果:
- 表面与体积的比率和水吸收被确定为临床试验方法的关键属性.
- 一种基于玻璃幻灯片适配器的方法成功生成了生物相关的降解和体外释放配置文件.
- 一个A级IVIVC已成功开发并通过使用子模型和不同的PLGA分子重量对RISPERIDONE植入物进行验证.
结论:
- 优化的体外溶解方法可以克服开发IVIVCs在现场形成植入物的挑战.
- 玻璃幻灯片适配器方法为准确的体外释放预测提供了一个重要的生物模拟环境.
- 这项工作为开发可靠的IVIVC在现场形成植入物,帮助监管提交和药物开发奠定了基础.
相关概念视频
01:16Methods for Studying Drug Absorption: In vitro
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In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
222
01:09Methods for Studying Drug Absorption: In situ
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In situ experiments, such as the Doluisio method and Single-Pass Perfusion technique, provide critical insights into drug uptake by simulating in vivo conditions for drug absorption.
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
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