Key Laboratory of Xin'an Medicine, Ministry of Education, Anhui University of Chinese Medicine, Hefei, Anhui, China.
College of Biotechnology and Pharmaceutical Engineering, West Anhui University, Lu'an, Anhui, China.
Drug Dev Ind Pharm. 2020 Nov;46(11):1776-1786. doi: 10.1080/03639045.2020.1821047. Epub 2020 Oct 12.
The aim of this study was to develop the Metformin Hydrochloride and Gliclazide (MH-GZ) sandwiched osmotic pump capsule which could overcome the problems associated with short half-life and burst release. The system could deliver drugs with different solubility simultaneously at zero-order rate, in which MH-GZ were filled in both sides of the push layer respectively. The single factor and orthogonal test were employed to obtain the optimized formulation with the evaluation index of similarity factor (ƒ). R language was used to visualized analyze the main influence factors of drug release and their correlations. Pharmacokinetic study was performed in beagle dogs compared to the marketed conventional product, which showed decreased C, prolonged T, and improved bioavailability, independent of pH and agitational speed but related to osmotic pressure differences across the semi permeable membrane. The designed sandwiched osmotic pump capsule proposed a promising substitute for the marketed product for the treatment of type 2 diabetes.
本研究旨在开发盐酸二甲双胍-格列齐特（MH-GZ）夹心渗透泵胶囊，以克服半衰期短和突释的问题。该系统可以零级速率同时输送不同溶解度的药物，其中 MH-GZ 分别填充在推动层的两侧。采用单因素和正交试验，以相似因子（ƒ）为评价指标，得到优化处方。采用 R 语言可视化分析药物释放的主要影响因素及其相关性。与市售普通制剂相比，在比格犬中进行了药代动力学研究，结果表明 C 降低，T 延长，生物利用度提高，与 pH 值和搅拌速度无关，但与半渗透膜两侧的渗透压差异有关。所设计的夹心渗透泵胶囊为治疗 2 型糖尿病的市售产品提供了一种有前途的替代方案。
