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含盐酸普萘洛尔的粘膜粘附性明胶口腔膜：机械性能、粘膜粘附性及生物药剂学性质评估

Mucoadhesive Gelatin Buccal Films with Propranolol Hydrochloride: Evaluation of Mechanical, Mucoadhesive, and Biopharmaceutical Properties.

作者信息

Jovanović Marija, Tomić Nataša, Cvijić Sandra, Stojanović Dušica, Ibrić Svetlana, Uskoković Petar

机构信息

Department of Materials Science and Engineering, Faculty of Technology and Metallurgy, University of Belgrade, Karnegijeva 4, 11120 Belgrade, Serbia.

Innovation Center of Faculty of Technology and Metallurgy, Karnegijeva 4, 11120 Belgrade, Serbia.

出版信息

Pharmaceutics. 2021 Feb 18;13(2):273. doi: 10.3390/pharmaceutics13020273.

DOI:10.3390/pharmaceutics13020273
PMID:33670448
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7922149/
Abstract

This study processes and characterizes propranolol hydrochloride/gelatin mucoadhesive buccal films. Two types of gelatin are used: Gelatin from porcine skin, type A (GA), and gelatin from bovine skin (GB). The influence of gelatin type on mechanical, mucoadhesive, and biopharmaceutical characteristics of buccal films is evaluated. Fourier-Transfer infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analysis show that GA with propranolol hydrochloride (PRH) in the film (GAP) formed a physical mixture, whereas GB with PRH (GBP) form a compound-complex. Results of mechanical testing (tensile test, hardness) revealed that GAP films exhibit higher elastic modulus, tensile strength, and hardness. A mucoahesion test shows that GBP has higher adhesion strength, while GAP shows higher work of adhesion. Both in vitro release study and in silico simulation indicated that processed films can provide effective drug transport through the buccal mucosa. In silico simulation shows improved bioavailability from buccal films, in comparison to the immediate-release tablets-indicating that the therapeutic drug dose can be markedly reduced.

摘要

本研究对盐酸普萘洛尔/明胶黏膜黏附性口腔膜进行了加工和特性表征。使用了两种类型的明胶：A型猪皮明胶（GA）和牛皮明胶（GB）。评估了明胶类型对口腔膜的机械、黏膜黏附及生物药剂学特性的影响。傅里叶变换红外光谱（FTIR）和差示扫描量热法（DSC）分析表明，膜中含盐酸普萘洛尔（PRH）的GA（GAP）形成了物理混合物，而含PRH的GB（GBP）形成了复合复合物。机械测试（拉伸试验、硬度）结果显示，GAP膜表现出更高的弹性模量、拉伸强度和硬度。黏膜黏附试验表明，GBP具有更高的黏附强度，而GAP表现出更高的黏附功。体外释放研究和计算机模拟均表明，加工后的膜可实现药物通过口腔黏膜的有效转运。计算机模拟显示，与速释片剂相比，口腔膜的生物利用度有所提高，这表明治疗药物剂量可显著降低。

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