Further enhancement of the sustained-release properties and stability of direct compression gel matrix bilayer tablets by controlling the particle size of HPMC and drug microencapsulation

被引：3

作者：

Liu, Tong ^{[1
]}

Wang, Jiahui ^{[1
]}

Feng, Yupeng ^{[1
]}

Wang, Haoran ^{[1
]}

Xu, Yunlong ^{[1
]}

Yin, Tian ^{[2
]}

Zhang, Yu ^{[1
]}

He, Haibing ^{[1
]}

Gou, Jingxin ^{[1
]}

Tang, Xing ^{[1
]}

机构：

[1] Shenyang Pharmaceut Univ, Sch Pharm, Dept Pharmaceut, Wenhua Rd 103, Shenyang 110016, Peoples R China

[2] Shenyang Pharmaceut Univ, Dept Funct Food & Wine, Shenyang 110116, Liaoning, Peoples R China

来源：

POWDER TECHNOLOGY | 2024年 / 448卷

关键词：

Theophylline; Salbutamol; Bilayer tablet; Sustained release; Direct compression method; IN-VITRO; MAILLARD REACTION; FORMULATION; HYDROCHLORIDE; THEOPHYLLINE; HYPROMELLOSE; MECHANISM; IMPURITY;

D O I：

10.1016/j.powtec.2024.120256

中图分类号：

TQ [化学工业];

学科分类号：

0817 ;

摘要：

The Theophylline and Salbutamol Bilayer Sustained-release Tablets (Yi Xi Qing (R)), prepared via wet granulation, discolor during long-term storage, and the process is less reproducible and more cumbersome. In this study, the direct compression (DC) method was used to prepare equivalent and stable theophylline-salbutamol bilayer sustained-release (TBS) tablets, using Yi Xi Qing (R) as a reference formulation (the relative bioavailabilities for theophylline and salbutamol were 96.3 % and 103.9 %, respectively, with release similarity factors of 60.12 and 80.99). Lipid microencapsulation of salbutamol via hot-melt extrusion (HME) and the use of HPMC with a particle size of less than 96.55 mu m (D90) in the theophylline layer enhanced the stability of salbutamol during long-term storage and controlled the release of theophylline from a minimal amount of gel matrix material, respectively. The results of this study may offer insights into the preparation of DC hydrophilic gel matrix bilayer tablets with high drug loading capacity.

引用

页数：13

共 48 条

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