DURECT Corporation, 2 Results Way, Cupertino, California 95014, USA.
AAPS J. 2010 Sep;12(3):437-42. doi: 10.1208/s12248-010-9199-8. Epub 2010 May 19.
Osmotically controlled implants yield precise zero-order drug delivery kinetics and are utilized in a number of applications. The implants deliver drugs for extended periods (weeks to years) and exhibit good in vivo/in vitro correlation. This paper reviews critical variables associated with these implants, with a focus on release rate testing. The extended-duration kinetics can be problematic when attempting to test for >70% cumulative delivery. An innovative scheme based on the scientific principles of operation of the system is described to ensure > 70% delivery at the target rate and duration for the DUROS Viadur (leuprolide acetate) implant.
渗透控制型植入物可实现精确的零级药物释放动力学，被广泛应用于多个领域。这些植入物能够持续释放药物（数周到数年），并且具有良好的体内/体外相关性。本文主要针对药物释放率测试，回顾了与这些植入物相关的关键变量。在尝试测试超过 70%的累积释放量时，这种长时间的动力学可能会产生问题。本文描述了一种基于该系统工作原理的创新性方案，以确保在目标速率和持续时间内，DUROS Viadur（醋酸亮丙瑞林）植入物的累积释放量超过 70%。
