Abstract
Loratadine, a second generation H1-receptor antagonist, works by blocking the action of histamine and is widely prescribed for itching, runny nose, watery eyes, and sneezing from "hay fever" and other allergic conditions. To ensure quality the main requirements for a medicinal product are safety, potency, efficacy and stability. This research work aimed to compare and assess the quality levels of different local brands of loratadine tablets available in the drug market of Bangladesh. Six different brands of loratadine 10 mg tablet manufactured by the local companies were used for the analysis. The evaluation was performed through the determination of weight variation, hardness, friability, percent potency, disintegration time, and dissolution profile in accordance with USP-NF specifications. All brands showed acceptable weight variation and % friability. The percent potency for tested samples by UV method ranges from 97.02%-108%, showing none of the brands contains less than 90% of the active principle as per the specification. The result of the physical and chemical studies, such as in-vitro dissolution, disintegration, hardness, etc., has been found to differ but lie within the specified limit. After analyzing the data obtained from the tests, it can be claimed that loratadine 10 mg tablets manufactured and marketed by several local companies in Bangladesh meet the quality standard required to achieve the desired therapeutic outcomes.
Highlights
Histamine plays a major role in triggering complex interaction between several inflammatory cells including, basophils, mast cells, neutrophils, dendritic cells, lymphocytes and eosinophils in response to various environmental/ allergic stimuli, resulting in allergic rhinitis, allergic asthma, pruritus, atopic dermatitis, etc [1]
The present study was conducted to make an equivalent evaluation of different quality control parameters such as the weight variation, hardness, friability, disintegration, dissolution, percentage potency profile of commercially available six different pharmaceutical brands of loratadine in Dhaka, Bangladesh, and to raise awareness among the medicine control authority and pharmaceutical manufacturers so that they become more conscious about maintaining the quality control standards provided by BP and Loratadine was approved by the FDA on December 21, 2001 [4]
All the brands of the loratadine 10 mg tablet were within the shelf-life and no irregularity was observed in the physical appearance in any of the sample used throughout the analysis
Summary
Histamine plays a major role in triggering complex interaction between several inflammatory cells including, basophils, mast cells, neutrophils, dendritic cells, lymphocytes and eosinophils in response to various environmental/ allergic stimuli, resulting in allergic rhinitis, allergic asthma, pruritus, atopic dermatitis, etc [1]. A significant breakthrough in antihistamine production occurred in the 1980s with the advent of the second generation H1-antihistamine, which are minimally sedative or non-sedative due to their restricted penetration of the blood brain barrier These medications are highly selective for the H1-receptor of histamine and have no anticholinergic effects [3]. To ensure the desired quality the drug manufacturers are required to check their products during and after manufacture, and at different intervals during the product's shelf life [12] Depending upon these facts, the present study was conducted to make an equivalent evaluation of different quality control parameters such as the weight variation, hardness, friability, disintegration, dissolution, percentage potency profile of commercially available six different pharmaceutical brands of loratadine in Dhaka, Bangladesh, and to raise awareness among the medicine control authority and pharmaceutical manufacturers so that they become more conscious about maintaining the quality control standards provided by BP and USP guidelines
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