Drug delivery devices for administering an active agent or a combination of active agents to a subject are provided. Specifically, multi-layer mucoadhesive drug delivery device are provided, including: (a) a mucoadhesive layer, containing at least one non-ionic polymer, at least one anionic polymer, at least one swelling modifier, and at least one buffering agent; (b) an effervescent layer, containing at least one permeation enhancer, an effervescent couple, comprising an anhydrous acid and an alkalizing agent, and at least one binder; and, (c) at least one active agent; wherein the at least one active agent is contained in both the mucoadhesive layer and the effervescent layer; wherein the at least one active agent contained in the effervescent layer is released from the drug delivery device along with the at least one permeation enhancer within 10 minutes, more preferably within 5 minutes, most preferably within 1 minute, of administration of the drug delivery device to a subject and wherein the at least one active agent contained in the mucoadhesive layer is released from the drug delivery device over a period of at least 8 hours, more preferably at least 12 hours, most preferably at least 24 hours, preferably with near zero-order kinetics, more preferably with zero-order kinetics. Methods of administering active agents to a subject using such multi-layer mucoadhesive drug deliver devices are also provided.
提供了用于向受试者施用活性剂或活性剂组合的给药装置。具体而言,提供了多层粘液黏附给药装置,包括(a) 粘胶层,包含至少一种非离子聚合物、至少一种阴离子聚合物、至少一种膨胀改性剂和至少一种缓冲剂;(b) 泡腾层,包含至少一种渗透
促进剂、由无
水酸和碱化剂组成的泡腾
偶联剂以及至少一种粘合剂;以及 (c) 至少一种活性剂;其中至少一种活性剂同时包含在粘胶层和泡腾层中;其中泡腾层中含有的至少一种活性剂与至少一种渗透
促进剂一起在给受试者施用给药装置后 10 分钟内,更优选 5 分钟内,最优选 1 分钟内从给药装置中释放出来,其中粘液黏附层中含有的至少一种活性剂在至少 8 小时,更优选至少 12 小时,最优选至少 24 小时的时间内从给药装置中释放出来,优选接近零阶动力学,更优选零阶动力学。还提供了使用这种多层粘液黏附给药装置向受试者给药的方法。