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一种新型基于功能型和非功能型压敏胶的芬太尼贴片的制备及体外评价。

Preparation and in vitro evaluation of a new fentanyl patch based on functional and non-functional pressure sensitive adhesives.

机构信息

Novel Drug Delivery Systems Department, Polymer Science Faculty, Iran Polymer and Petrochemical Institute, P.O. Box 14965-115, Tehran, Iran.

出版信息

AAPS PharmSciTech. 2010 Mar;11(1):278-84. doi: 10.1208/s12249-009-9366-3. Epub 2010 Feb 25.

Abstract

In this study, some single-layer and double-layer transdermal drug delivery systems (TDDSs) with different functional and non-functional acrylic pressure-sensitive adhesives (PSAs) were prepared. For this purpose, fentanyl as a drug was used. The effects of PSAs type, single-layer and double-layer TDDSs on skin permeation and in vitro drug release from devices were evaluated using a hydrodynamically well-characterized Chien permeation system fitted with excised rat abdominal skin. The adhesion properties of devices such as peel strength and tack values were obtained as well. It was found that TDDS with -COOH functional PSA showed the lowest steady-state flux. Double-layer TDDS displayed a constant flux up to 72 h. In double- and single-layer devices after 1 and 3 h, respectively, drug release followed Higuchi's kinetic model. Formulations with the highest percentage of -COOH functional PSA have displayed the lowest flux. The double-layer TDDSs with non-functional PSA demonstrated the suitable skin permeation rate close to Duragesic(R) TDDS and suitable adhesion properties.

摘要

在这项研究中,制备了一些具有不同功能和非功能丙烯酸压敏胶(PSA)的单层和双层经皮给药系统(TDDS)。为此,使用了芬太尼作为药物。使用水力特性良好的 Chien 渗透系统和离体大鼠腹部皮肤评估了 PSA 类型、单层和双层 TDDS 对药物经皮渗透和体外释放的影响。还获得了装置的粘附性能,如剥离强度和初粘性值。结果发现,具有-COOH 功能 PSA 的 TDDS 显示出最低的稳态通量。双层 TDDS 显示出恒定的通量,直至 72 小时。在 1 小时和 3 小时后,双层和单层装置中的药物释放分别遵循 Higuchi 动力学模型。具有最高-COOH 功能 PSA 百分比的制剂显示出最低的通量。具有非功能 PSA 的双层 TDDS 显示出接近 Duragesic(R) TDDS 的适宜皮肤渗透速率和适宜的粘附性能。

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