Quality Comparisons of Acetaminophen Tablets Commercially Available in Thailand
Keywords:Acetaminophen Tablet, Quality Control, Uniformity of Weight, Tablet Friability, Tablet Breaking Force, Dissolution Test, Assay, Uniformity of Dosage Unit
Acetaminophen or paracetamol is one of the most widely used over-the-counter analgesic and antipyretic medications. Many different brands of acetaminophen tablets are available in Thailand market where people can easily access medicines. The aim of this present study was to compare the quality of three brands of acetaminophen tablets (500 mg/tablet) marketed in Thailand with various prices. The three brands of acetaminophen tablets were obtained from a retail pharmacy and their qualities were evaluated using criteria and methods according to USP 40 and BP 2017 together with CDER--Center for Drug Evaluation and Research guidance 1997. The quality of the acetaminophen tablets was compared based on uniformity of weight, tablet friability, tablet breaking force, dissolution test, assay procedure as well as uniformity of dosage unit. All brands conformed to USP and BP criteria. According to CDER guidance, dissolution profiles of two brands were considered to be equivalent, but they are slightly different from the other one. However, the overall quality of the three brands of acetaminophen tablets was satisfactory as they met the USP 40 and BP 2017 requirements.
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