Abstract
Objective: This study was employed to evaluate the quality of marketed oral tablets containing clopidogrel bisulfate. Tablets produced by various companies and commercialized in the Iraq market were used in the study. Methods: Batches of clopidogrel bisulfate conventional tablets (containing 75 mg of drug) were exposed to the quality control tests. These tests involved friability, weight variation, hardness, drug content, disintegration time, and in vitro release study; these tests were conducted depending on USP pharmacopeia. Results: The data indicate that all batches of clopidogrel bisulfate complied with the limitations of USP pharmacopeia for variation of weight, results of the hardness of tablets were 7.2-9.6 Kg/cm2. Friability value (% loss) was less than one, which was within the required limits. The time of disintegration was less than 25 min in both artificial gastric fluid (AGF) and artificial intestinal fluid (AIF). Drug content was observed between 97.1 % and 99.8 %, indicating compliance with the limits of pharmacopeia (85-115 %). An in vitro release study of batches was greater than 80 % within 25 min. Conclusion: All batches of clopidogrel bisulfate were manufactured within the criteria of tablet manufacturing. The quality control tests of tablets showed acceptable pharmaceutical properties (effectiveness and safety) that lie within the limits of USP pharmacopeia.
Highlights
Quality control studies of drug products are regarded as a substantial process of the pharmaceutical industry, which includes all processes that are performed to ensure the desired level of quality of drug products [1]
Et al performed a quality control study on different brands of carbamazepine conventional tablets marketed in Bangladesh, in this study, the tablets were subjected to various parameters such as weight variation, friability, hardness, disintegration time, and in vitro release study; the study indicates that all brands of carbamazepine tablets meet the limits of USP (United State of Pharmacopeia)
All brands meet the specifications in the test of weight variation, the tablets of carbamazepine disintegrated within 15 min and meet USP specification, the release different carbamazepine tablets were satisfactory within 45 min and ranged from 83.44% to 94.5%, so the study concluded that all brands of carbamazepine available in Bangladesh meet USP limitation for quality control testing [6]
Summary
Quality control studies of drug products are regarded as a substantial process of the pharmaceutical industry, which includes all processes that are performed to ensure the desired level of quality of drug products [1]. This study aimed to make an evaluation of quality control for oral filmcoated tablets of clopidogrel bisulfate that were fabricated by various pharmaceutical companies that possess standards of pharmacopeia and are available on the Iraq pharmaceutical market. Et al performed a quality control study on different brands of carbamazepine conventional tablets marketed in Bangladesh, in this study, the tablets were subjected to various parameters such as weight variation, friability, hardness, disintegration time, and in vitro release study; the study indicates that all brands of carbamazepine tablets meet the limits of USP (United State of Pharmacopeia). All brands meet the specifications in the test of weight variation, the tablets of carbamazepine disintegrated within 15 min and meet USP specification, the release different carbamazepine tablets were satisfactory within 45 min and ranged from 83.44% to 94.5%, so the study concluded that all brands of carbamazepine available in Bangladesh meet USP limitation for quality control testing [6]
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