用USP仪器对药品的体外溶出度研究——IV

Q2 Pharmacology, Toxicology and Pharmaceutics Drug Delivery Letters Pub Date : 2021-07-12 DOI:10.2174/2210303111666210712101322
Mohit Kumar, U. Mandal
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引用次数: 1

摘要

本文的目的是回顾用流通式仪器(USP IV型仪器)进行的剂型溶出度研究的各个方面。USP IV型装置由泵组成,该泵通过流通池迫使溶解介质向上流动。溶解介质的贮存器连接到细胞上,细胞垂直安装有过滤系统,以抑制未溶解颗粒的逃逸。该仪器是专门为粉末、微粒、颗粒和片剂设计的。在这种体外溶出方法中,将试样置于小体积流通池的底部,溶剂在37°C的温度下通过。本研究对建立体内外关系具有重要意义。同样,这项研究用于区分测试样本中药物释放的程度,以预测其在实际患者群体中的体内生存能力。流通池用于测定微颗粒、栓剂、植入物、含有极低水溶性药物的控释制剂的溶出度。与其他现有的药典溶解装置相比,具有小颗粒尺寸和大表面积的药物以更快的速度溶解。文章还重点介绍了一些使用USP IV型仪器进行的体外溶出度研究。
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In-vitro Dissolution Study of Pharmaceutical Products with USP Apparatus–IV
The objective of the present article is to review various aspects of dissolution studies of dosage forms performed with the flow-through apparatus (USP type–IV apparatus). USP type-IV apparatus is comprised of a pump that compels the dissolution media upwards via the flow-through cell. A reservoir of dissolution medium is attached to the cell that is mounted vertically with a filter system to restrain the escape of un-dissolved particles. The apparatus is specially designed for powders, micro particles, pellets, and tablets. In this type of in vitro dissolution method, the test sample is placed in the bottom of the small-volume flow-through cell, and the solvent passes through it at a temperature of 37°C. This study is significant to build up the in-vivo and in-vitro relationship. Likewise, this study is used to distinguish the extent of medication released from the tested sample to foresee it’s in vivo viability in the actual patient population. The flow-through cell is used to determine the dissolution of micro-particulate, suppositories, implants, controlled-release formulations with drugs that have very low aqueous solubility. The drugs with small particle size and large surface area are dissolved at a faster rate as compared to other existing and compendia dissolution apparatuses. The article also highlights some of the in vitro dissolution studies carried out with the USP type-IV apparatus.
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来源期刊
Drug Delivery Letters
Drug Delivery Letters Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
CiteScore
1.70
自引率
0.00%
发文量
30
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