Quality Assessment of Brands of Prednisolone (5 Mg) Tablets Marketed in Abuja Metropolis of Nigeria

IF 1 4区医学 Q4 PHARMACOLOGY & PHARMACY

Dissolution Technologies Pub Date : 2021-01-01 DOI:10.14227/DT280121P24

J. Isaac, Galadima I. Hayatu, J. E. John, K. Ekere, Aisha Daburi, Sunday O. Omachoko, Philip F. Buiders

引用次数: 2

Abstract

This study aims to evaluate the quality of brands of prednisolone tablets marketed in Nigeria. Quality control parameters such as weight variation, hardness, friability, disintegration, assay, and dissolution were assessed. Ten of 11 brands tested met the United States Pharmacopeia (USP) specifications for dissolution of immediate-release dosage forms at stage S1 or S2, but one brand failed to meet the requirement even at stage S3. Using a validated method, all brands except one contained the labelled drug amount per USP specifications (100 ± 10%). Seven brands failed the hardness test, but there were no issues with other parameters like friability, weight variation, and disintegration. This study demonstrates that most generics of prednisolone tablets currently circulating in Abuja, Nigeria are of good quality.

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尼日利亚阿布贾市售品牌强的松龙(5mg)片质量评价

本研究旨在评价在尼日利亚销售的强的松龙片剂品牌的质量。质量控制参数，如重量变化，硬度，脆性，崩解，测定和溶出度进行了评估。被测试的11个品牌中有10个符合美国药典(USP)对速释剂型在S1或S2阶段溶出度的要求，但有一个品牌甚至在S3阶段也未能满足要求。使用经过验证的方法，除一个品牌外，所有品牌均含有按USP规范标示的药物量(100±10%)。7个品牌的硬度测试不合格，但其他参数如易碎性、重量变化和崩解性没有问题。这项研究表明，目前在尼日利亚阿布贾流通的大多数非专利强的松龙片剂质量良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Dissolution Technologies 医学-药学

CiteScore

1.20

自引率

33.30%

发文量

审稿时长

3 months

期刊介绍： Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing of pharmaceuticals. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics. Dissolution Technologies welcomes submissions related to dissolution, in vitro release, and disintegration testing. These topics should be the major focus of the article. Do not submit articles where the focus is formulation development with dissolution testing as one of many tests.