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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