药物递送系统(DDS)控制量,rate,和药物在体内的给药部位以及它们的释放和ADME(吸收,分布,新陈代谢,排泄)。在各种类型的DDS中,用于溶解和吸收的量控制的DDS增加了生物利用度。时间和数量受控的DDS是被分类为(1)膜型的控释制剂,(2)矩阵型,(3)渗透型,和(4)离子交换型。定时释放制剂还控制药物的释放和吸收的时间和量。位置和数量控制的DDS的特征在于结肠递送和肠淋巴靶向以改善药物物质的释放和ADME。最后,Site-,time-,和数量控制的DDS是胃滞留制剂和口腔局部递送,以改善部位保留,释放,和药物的ADME。DDS可以增强疗效,减少不利影响,并优化各种药物产品的给药频率,以增加患者价值。这篇综述的重点是推出口服DDS的患者价值和工业考虑因素。我们提供候选和上市DDS的技术概述,以及考虑到辅料的工业化技术的利弊,制造,和储存稳定性。此外,为了证明该技术的有用性,并支持为患者选择和开发最佳技术,我们还描述了来自临床研究和分析的患者价值,特别是关于增加新的医疗选择,更高的功效,减少不利影响,减少剂量和就诊次数,更容易管理,更高的生活质量,更大的坚持,和满意度。
Drug delivery systems (
DDS) control the amount, rate, and site of administration of drug substances in the body as well as their release and ADME (absorption, distribution, metabolism, excretion). Among the various types of
DDS, amount-controlled
DDS for solubilization and absorption increase the bioavailability. Time- and amount-controlled
DDS are controlled release formulations classified as (1) membrane-type, (2) matrix-type, (3) osmotic-type, and (4) ion-exchange type. Timed-release formulations also control the time and amount of release and the absorption of drugs. Site- and amount-controlled
DDS are characterized by colonic delivery and intestinal lymph-targeting to improve release and ADME of drug substances. Finally, site-, time-, and amount-controlled DDS are gastroretentive formulations and local delivery in the oral cavity to improve site retention, release, and ADME of drugs. DDS can enhance efficacy, reduce adverse effects, and optimize the dosing frequency of various drug products to increase patient value. This review focuses on patient value and industrial considerations of launched oral
DDS. We provide a technological overview of candidate and marketed DDS, as well as the pros/cons of the technologies for industrialization with consideration to excipients, manufacturing, and storage stability. Moreover, to demonstrate the usefulness of the technology and support the selection and development of the best technologies for patients, we also describe patient value from clinical studies and analyses, particularly with regard to increased new medical options, higher efficacy, reduced adverse effects, reduced number of doses and clinic visits, easier administration, higher quality of life, greater adherence, and satisfaction.