US Food and Drug Administration, Center for Veterinary, Medicine, Rockville, MD 20855, United States.
J Control Release. 2010 Feb 25;142(1):2-7. doi: 10.1016/j.jconrel.2009.09.028. Epub 2009 Oct 3.
Parenteral drug delivery systems can be designed to provide the flexible delivery characteristics needed in an evolving therapeutic landscape. The goal of some parenteral formulations is to maintain effective drug concentrations over a period of months or years, thereby enhancing patient compliance. When functioning as intended, these formulations can be used to minimize undesirable effects that may occur in response to the fluctuating drug concentrations effected by immediate release products. In other cases, targeted parenteral delivery systems allow for the deposition of drug directly to its site of action, thereby minimizing systemic toxicity. While these novel formulations can be beneficial to both human and veterinary patients, disastrous effects can occur if there is an unanticipated change in product quality or performance. With these thoughts in mind, the Controlled Release Society (CRS) hosted a 2007 workshop entitled "In Vitro and In Vivo Considerations Associated with Parenteral Sustained Release Products". The objective of that workshop was to explore the physicochemical properties of parenteral products and the factors that could alter their in vitro and in vivo performance characteristics. The outcomes of that workshop were summarized in a Journal of Controlled Release article. In response to questions raised during that workshop, the CRS and the American Association of Pharmaceutical Scientist (AAPS) co-hosted the follow-up 2008 workshop entitled "Critical Variables in the In Vitro and In Vivo Performance of Parenteral Sustained Release Products". This 2008 workshop provided a platform for exploring the application of design space concepts to these complex pharmaceuticals, and to consider the corresponding in vitro test methods that can be used to set batch release specifications. To foster discussion, the workshop provided two afternoon breakout sessions where critical questions were explored. This manuscript captures the results of those discussions.
注射给药系统可以设计为提供治疗领域中不断发展所需的灵活给药特性。一些注射制剂的目标是在数月或数年内维持有效的药物浓度，从而提高患者的依从性。当这些制剂按预期发挥作用时，可以用来最小化由于即时释放产品引起的药物浓度波动而产生的不良影响。在其他情况下，靶向注射给药系统允许将药物直接递送到作用部位，从而最小化全身毒性。虽然这些新型制剂对人类和兽医患者都可能有益，但如果产品质量或性能发生意外变化，可能会产生灾难性的影响。考虑到这些因素，控释学会（CRS）于 2007 年举办了一次题为“与注射持续释放产品相关的体外和体内考虑因素”的研讨会。该研讨会的目的是探讨注射产品的物理化学性质以及可能改变其体外和体内性能特征的因素。该研讨会的结果总结在《控释杂志》的一篇文章中。为了回应该研讨会期间提出的问题，CRS 和美国制药科学家协会（AAPS）共同主办了后续的 2008 年题为“注射持续释放产品体外和体内性能的关键变量”的研讨会。该 2008 年研讨会为探索设计空间概念在这些复杂药物中的应用提供了一个平台，并考虑了可用于设定批量放行规格的相应体外测试方法。为了促进讨论，研讨会提供了两个下午的分组讨论，在这些分组讨论中探讨了关键问题。本文档记录了这些讨论的结果。
