Ranade V V
Action Medical Marketing Co. Libertyville, Illinois.
J Clin Pharmacol. 1990 Oct;30(10):871-89. doi: 10.1002/j.1552-4604.1990.tb03566.x.
In comparison with many of the other drug delivery systems, implantable pumps and implants for variable rate delivery are at a crude stage of development. Although exceptions exist, the typical implantable pump consists of an electromechanically complex mechanism to regulate drug delivery from a percutaneous refillable reservoir, while power to drive the system comes from a transcutaneous energy transmission system. The potential for electrical or mechanical failure is high, and the systems are not yet sufficiently convenient or easy to use to recommend in a routine therapy. Problems with refilling of an apparently well designed implanted reservoir have been observed while, at the same time, cutaneous energy transmission systems are not well established. In most instances, the development of an elementary osmotic pump system dosage form follows a well defined path of physical-chemical formulation and clinical testing. The benefits most often provided by the dosage form are expected to be (1) increase in selectivity of drug action achieved by the system's zero-order release rate, and (2) decrease in frequency of administration. The success in achieving these values is quantifiable from the pharmacology of the drug substance and its pharmacokinetics. Osmotic and other technical approaches to producing economical, rate-controlled dosage forms will make it possible for all new pharmaecutical products to carry kinetic specification of rate as well as static specification of content. This review considers the characteristics of the ideal implantable pump, the clinical situations which require pumps, the limitations of portable pumps, and the detailed characteristics of existing implantable pumps and implants. Most of the review, however, focuses on insulin delivery because of the importance of this subject.
与许多其他药物递送系统相比，用于可变速率递送的可植入泵和植入物仍处于发展的初级阶段。虽然存在例外情况，但典型的可植入泵由一个机电复杂的机构组成，用于调节来自经皮可再填充储液器的药物递送，而驱动该系统的动力来自经皮能量传输系统。电气或机械故障的可能性很高，并且这些系统在日常治疗中还不够方便或易于使用，不值得推荐。已经观察到，即使是设计明显良好的植入式储液器在再填充方面也存在问题，与此同时，皮肤能量传输系统还不完善。在大多数情况下，基本渗透泵系统剂型的开发遵循明确的物理化学配方和临床试验路径。该剂型最常带来的益处预计为：（1）通过系统的零级释放速率提高药物作用的选择性；（2）减少给药频率。实现这些目标的成功程度可从药物的药理学及其药代动力学中量化。生产经济、速率可控剂型的渗透及其他技术方法将使所有新药品都能具备速率的动力学规格以及含量的静态规格。本综述考虑了理想可植入泵的特点、需要泵的临床情况、便携式泵的局限性以及现有可植入泵和植入物的详细特点。然而，由于该主题的重要性，本综述大部分内容聚焦于胰岛素递送。
