Dissolution Specifications for Ibuprofen Soft Gelatin Capsules: A Proposal

被引：0
|
作者：
Mayet-Cruz, Lourdes [1 ]
Rodriguez, Juan Manuel [1 ]
Juarez-Lopez, Emily [1 ]
Jung-Cook, Helgi [1 ]
机构：
[1] Univ Nacl Autonoma Mexico, Fac Quim, Dept Farm, Mexico City, DF, Mexico
来源：
DISSOLUTION TECHNOLOGIES | 2023年 / 30卷 / 02期
关键词：
Ibuprofen; soft gelatin capsules; release profiles; rupture test; dissolution;
D O I：
10.14227/DT300223P74
中图分类号：
R914 [药物化学];
学科分类号：
100701 ;
摘要：
The aim of the present study was to propose a Q dissolution value as a quality control test for 400-mg ibuprofen soft gel capsules using the dissolution recommendations included in the FDA dissolution database. Two commercial batches of the reference product and two batches of three generic products were selected. Dissolution profiles were determined by using apparatus 1 at 150 rpm with 900 mL of phosphate buffer pH 7.2 as dissolution media. To determine the probability of passing the USP dissolution test, the R program with Burdick codes were used. Quality control tests including rupture time were also performed. Results showed that a Q dissolution value of 80% at 20 minutes could be recommended as a quality control test. A moderate correlation was found between rupture time and the percentage dissolved at 10 minutes.
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收藏
页码：74 / 77
页数：4
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