膨润土钠作为缓释片制剂辅料的潜在应用研究。

Investigation of the potential application of sodium bentonite as an excipient in formulation of sustained release tablets.

作者信息

Alkrad Jamal Alyoussef, Abu Shmeis Reham, Alshwabkeh Iyad, Abazid Husam, Mohammad Mohammad Amin

机构信息

Faculty of Pharmacy, Isra University, PO Box 22 and 23, Amman, Jordan.

Faculty of Pharmacy, Department of Clinical Pharmacy & Therapeutics, Applied science Private University, Amman, Jordan.

出版信息

Asian J Pharm Sci. 2017 May;12(3):259-265. doi: 10.1016/j.ajps.2017.01.004. Epub 2017 Jan 24.

DOI:10.1016/j.ajps.2017.01.004

PMID:32104337

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7032171/

Abstract

In this study, the application of sodium bentonite (SB) in formulation of tablets prepared by direct compression for oral administration was tested. Three different model drugs with different solubilities: paracetamol, diclofenac sodium and metformin HCl were tested. Each drug was mixed with SB at ratio of 50% and the mixtures were subsequently compressed. Compatibility studies were conducted using both Deferential Scanning Calorimeter (DSC) and Fourier Transform Infrared Spectroscopy (FTIR). The dissolution profile for each drug was determined in USP-buffers at different time intervals. Diclofenac sodium in pH 6.8 buffer and paracetamol in both pH 6.8 and pH 4.5 buffers showed extended release. However, metformin HCl showed immediate release at the different pH values. The study showed that using SB was possible to prepare tablets with different release profiles. However, these profiles differ depending on dissolution media and drug type.

摘要

在本研究中，测试了钠基膨润土（SB）在通过直接压片法制备口服片剂配方中的应用。测试了三种不同溶解度的模型药物：对乙酰氨基酚、双氯芬酸钠和盐酸二甲双胍。每种药物均与SB按50%的比例混合，随后对混合物进行压片。使用差示扫描量热仪（DSC）和傅里叶变换红外光谱（FTIR）进行相容性研究。在不同时间间隔测定每种药物在USP缓冲液中的溶出曲线。双氯芬酸钠在pH 6.8缓冲液中以及对乙酰氨基酚在pH 6.8和pH 4.5缓冲液中均显示出缓释。然而，盐酸二甲双胍在不同pH值下均显示出速释。该研究表明，使用SB有可能制备出具有不同释放曲线的片剂。然而，这些曲线因溶出介质和药物类型而异。