School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang, 110016, China.
School of Pharmacy, Liaoning University, No.66, Chongshan Road, Shenyang, 110036, China.
AAPS PharmSciTech. 2021 Jan 6;22(1):37. doi: 10.1208/s12249-020-01886-8.
In 2017, there are 451 million people with diabetes worldwide. These figures were expected to increase to 693 million by 2045. The research and development of hypoglycemic drugs has become a top priority. Among them, sulfonylurea hypoglycemic drugs such as glipizide are commonly used in non-insulin-dependent type II diabetes. In order to adapt to the wide range of hypoglycemic drugs and the different individual needs of patients, this topic used glipizide as a model drug, and prepared glipizide preparations with 3D printing technology. The purpose of this study was to investigate the prescription applicability and control-release behavior of structure and explore the application prospects of 3D printing personalized drug delivery formulations. This article aims to establish a production process for personalized preparations based on 3D printing technology. The process is easy to obtain excipients, universal prescriptions, flexible dosages, exclusive customization, and integrated automation. In this paper, the UV method was used to determine the in vitro release and content analysis method of glipizide; the physical and chemical properties of the glipizide were investigated. The established analysis method was inspected and evaluated, and the experimental results met the methodological requirements. Glipizide controlled-release tablets were prepared by the semisolid extrusion (SSE) method using traditional pharmaceutical excipients combined with 3D printing technology. The formulation composition, in vitro release, and printing process parameters of the preparation were investigated, and the final prescription and process parameters (traveling speed 6.0-7.7 mm/s and extruding speed 0.0060-0.0077 mm/s) were selected through comprehensive analysis. The routine analysis results of the preparation showed that the performance of the preparation meets the requirements. In order for 3D printing technology to play a better role in community medicine and telemedicine, this article further explored the universality of the above prescription and determined the scope of application of prescription drugs and dosages. Glipizide, gliclazide, lornoxicam, puerarin, and theophylline were used as model drugs, and the range of drug loading percentage was investigated. The results showed when the solubility of the drug is 9.45 -8.34 mg/mL, and the drug loading is 3-43%; the release behavior is similar.
2017 年，全球有 4.51 亿人患有糖尿病。预计到 2045 年，这一数字将增加到 6.93 亿。降糖药物的研发已成为当务之急。其中，格列吡嗪等磺酰脲类降糖药常用于非胰岛素依赖型 2 型糖尿病。为了适应广泛的降糖药物和患者个体需求的不同，本课题以格列吡嗪为模型药物，采用 3D 打印技术制备格列吡嗪制剂。本研究旨在探讨结构的处方适用性和控制释放行为，探索 3D 打印个性化药物传递制剂的应用前景。本文旨在建立基于 3D 打印技术的个性化制剂生产工艺。该工艺易于获得辅料、通用处方、灵活剂量、独家定制和集成自动化。本文采用 UV 法测定格列吡嗪体外释放度和含量分析方法；考察格列吡嗪的理化性质。对建立的分析方法进行了考察和评价，实验结果符合方法学要求。采用半固态挤出（SSE）法，以传统药用辅料与 3D 打印技术相结合，制备格列吡嗪控释片。考察了制剂的处方组成、体外释放度和打印工艺参数，并通过综合分析选择了最终的处方和工艺参数（行进速度 6.0-7.7mm/s 和挤出速度 0.0060-0.0077mm/s）。制剂常规分析结果表明，制剂性能符合要求。为了使 3D 打印技术在社区医疗和远程医疗中发挥更好的作用，本文进一步探讨了上述处方的通用性，确定了处方药物和剂量的适用范围。以格列吡嗪、格列齐特、洛索洛芬、葛根素和茶碱为模型药物，考察了药物载药量范围。结果表明，当药物的溶解度为 9.45-8.34mg/mL，药物载药量为 3-43%时，释放行为相似。
