Abstract：
Physicochemical properties (drug release, peel strength, adhesion, and stiffness) of Hokunalin® Tape (Hokunalin) and 13 generic transdermal bronchodilator patches containing tulobuterol were characterized and evaluated for comparison. Drug-release studies evaluating sustained release behavior demonstrated better performance by the drug Hokunalin, than the generics MED, YP, Sawai, and Teikoku. Hokunalin yield a 16.2% release 1 hour after initiation, 30.1% at 3 hours, 50.0% at 8 hours. In comparison, the generics MED, YP, Sawai, and Teikoku showed an intermediate release behavior to that of Hokunalin, with more than 80% release after 8 hours. A 90-degree peel adhesion test for tape peel strength demonstrated that the generic MED (4.99 N), YP (3.26 N), Sawai (4.17 N), and Teikoku (4.37 N) tapes yielded significantly higher values compared to Hokunalin (2.66 N). Probe tack tests, evaluating adhesive strength, yielded significantly higher values for the generics HMT (4.89 N)and Towa (4.25 N) compared to Hokunalin (3.66 N). Furthermore, for the stiffness-softness test, a significantly higher value was obtained for each generic yielded compared to Hokunalin (3.7-degree). These factors are important components of product qualities that affect treatment efficacy, including \"ease of application\" and other usability factors.
摘要：
物理化学性质(药物释放，剥离强度,附着力,和硬度）的Hokunalin®胶带（Hokunalin）和13种含有妥洛特罗的通用经皮支气管扩张剂贴片进行了表征和评估，以进行比较。评估持续释放行为的药物释放研究表明，药物Hokunalin具有更好的性能，比MED的仿制药，YP,Sawai,还有Teikoku.Hokunalin在开始后1小时释放16.2%，3小时时30.1%,8小时时50.0%。相比之下,仿制药MED，YP,Sawai,Teikoku表现出与Hokunalin相比的中间释放行为，8小时后释放超过80%。胶带剥离强度的90度剥离附着力测试表明，通用MED（4.99N），YP(3.26N),Sawai(4.17N),和Teikoku（4.37N）胶带的值明显高于Hokunalin（2.66N）。探头粘性试验,评估粘合强度，与Hokunalin（3.66N）相比，仿制药HMT（4.89N）和Towa（4.25N）的值明显更高。此外，对于刚度-柔软度测试，与Hokunalin（3.7度）相比，每个仿制药的产量都获得了显着更高的值。这些因素是影响治疗效果的产品质量的重要组成部分，包括“易于应用”和其他可用性因素。
