Comparative Evaluation of Different Brands of Loratadine Tablets Marketed in Addis Ababa, Ethiopia

Abrham Temesgen, Yohannis Eshetu, M. Nigatu
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Abstract

The impact of counterfeit and substandard medicines has been increasing and becoming a public health problem as it significantly increases mortality and morbidity in low income countries. Loratadine is among the drug classes which are most falsified worldwide and is a frequently prescribed anti-allergy medication. As Ethiopia is one of the low-income countries and depends mostly on imported pharmaceutical products, it is necessary to evaluate the quality of drug products being marketed. This study was conducted with the objective of evaluating and comparing the quality of different brands of loratadine 10 mg tablets collected from pharmacy outlets in Addis Ababa city. Tablets were evaluated for weight variation, thickness, hardness, friability, disintegration time and in vitro drug release. All products complied with the pharmacopeial specifications for weight variation and friability. With regard to disintegration time, all sample products disintegrate in less than 15 min as per the pharmacopeial requirement except one product (product E) which is out of the pharmacopeial specification. Dissolution test showed that all the tested products released more than 80% of drug content within 60 min which is in agreement with the pharmacopeial specification.    
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埃塞俄比亚亚的斯亚贝巴市不同品牌氯雷他定片的比较评价
假药和不合格药品的影响一直在增加,并成为一个公共卫生问题,因为它大大增加了低收入国家的死亡率和发病率。氯雷他定是世界上被伪造最多的药物之一,是一种常用的抗过敏药物。由于埃塞俄比亚是低收入国家之一,主要依赖进口药品,因此有必要对销售的药品质量进行评估。本研究旨在评价和比较亚的斯亚贝巴市药店不同品牌氯雷他定10mg片的质量。对其重量变化、厚度、硬度、脆性、崩解时间和体外释放度进行了评价。所有产品均符合药典规定的重量变化和易碎性。崩解时间方面,除1个产品(产品E)不符合药典规范外,所有样品产品均按药典要求在15分钟内崩解。溶出度试验表明,所有被试产品在60 min内释放量均大于药物含量的80%,符合药典规定。
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