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dc.contributor.authorNyamweya, Nasser N
dc.contributor.authorKimani, Samantha N
dc.contributor.authorAbuga, Kennedy O
dc.identifier.citationNyamweya NN, Kimani SN, Abuga KO. Chewable Antacid Tablets: Are Disintegration Tests Relevant? AAPS PharmSciTech. 2020 May 17;21(5):139. doi: 10.1208/s12249-020-01696-y. PMID: 32419049.en_US
dc.description.abstractA recently published FDA guidance on chewable tablets has addressed the quality attributes of this class of dosage forms. This study evaluated disintegration as a quality attribute for a number of commercially available chewable antacid tablets. Additionally, acid-neutralizing-capacity values were evaluated. A number of the products exhibited prolonged disintegration times-which were far longer than those of conventional immediate-release tablets. The mean disintegration times ranged from 6 to more than 60 min in distilled water and from 9 to over 60 min in 0.1 N HCl. The products with longer disintegration times had higher breaking force and tensile strength values. Despite the range in disintegration times, all products met the criteria for acid-neutralizing capacity. These results indicate a need for patients to be aware of the need to thoroughly chew antacid tablets upon administration. Given these considerations, disintegration testing would be a useful quality control test in evaluating these dosage forms as the implicit assumption by the manufacturer that patients will chew the product sufficiently may not be met in every case.en_US
dc.publisherUniversity of Nairobien_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.subjectFDA guidance; antacids; chewable tablets; disintegration.en_US
dc.titleChewable Antacid Tablets: Are Disintegration Tests Relevant?en_US

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Attribution-NonCommercial-NoDerivs 3.0 United States
Except where otherwise noted, this item's license is described as Attribution-NonCommercial-NoDerivs 3.0 United States