稳定性增强固态 (SESS) 的药理动力学可行性 诺福维尔迪索普罗素自由基晶体
Byoung Hoon You1, Mingoo Bae1, Seung Yon Han1
1College of Pharmacy and Integrated Research Institute for Drug Development, Dongguk University_Seoul, 32 Dongguk-lo, Ilsandong-gu, Goyang-si 10326, Gyeonggi-do, Republic of Korea.
Pharmaceutics
|May 27, 2023
概括
一种新的特诺福维尔二氧化晶体 (SESS-TD) 显示出改善的生物可用性和与市场上销售的TDF配方可比的药理动力学. 这种稳定的晶体配方可能为TDF在艾滋病毒治疗中提供一个可行的替代方案.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物开发 药物开发
- 病毒学 病毒学
背景情况:
- 诺福维尔 (TEV) 的生物可用性较差,需要开发前药物.
- 诺福维尔二氧化 fumarate (TDF) 是 TEV. 的一个在市场上销售的原药.
- 一种新的稳定性增强的固态TD自由基晶体 (SESS-TD晶体) 显示出更好的可溶性和稳定性.
研究的目的:
- 评估SESS-TD晶体的药物动力学可行性.
- 为了评估TEV药理动力学的稳定性,在给药后,SESS-TD晶体存储了12个月.
主要方法:
- 与TEV和TDF相比,SESS-TD晶体的药理动力学评估.
- 在使用12个月存储的SESS-TD晶体和TDF后评估TEV的药理动力学概况.
主要成果:
- 与TEV相比,SESS-TD晶体和TDF显著增加了TEV生物可用性 (F) 和全身暴露 (AUC,Cmax).
- 在SESS-TD晶体和TDF组之间,TEV的药理动力学概况是可比的.
- 在服用SESS-TD晶体和12个月存储的TDF后,TEV的药理学概况保持不变.
结论:
- SESS-TD晶体显示出足够的药物动力学可行性.
- 改善的生物可用性和长期稳定性表明SESS-TD晶体可能会取代TDF.
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