1. Chewable Antacid Tablets: Are Disintegration Tests Relevant?
- Author
-
Nyamweya NN, Kimani SN, and Abuga KO
- Subjects
- Chemistry, Pharmaceutical, Dosage Forms, Kinetics, Solubility, Tablets, Tensile Strength, United States, United States Food and Drug Administration, Water, Antacids administration & dosage, Antacids chemistry
- Abstract
A 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.
- Published
- 2020
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