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Dissolution testing of enteric coated aspirin tablets

by A M Healy, O I Corrigan
Irish Pharmacy Journal ()

Abstract

In order to investigate the enteric properties of delayed release aspirin (acetylsalicylic acid) tablets that showed cracks in the enteric coating of 66% of the tablets, a USP dissolution test was performed on six 300 mg randomly selected tablets from a single container and their appearance and dissolution behavior were compared to further batches from the same manufacturer; the pharmacists' role in assessing product quality before dispensing any item to a patient is also discussed. Prior to the dissolution test, the 6 tablets were examined visually. No cracks were seen in the coating of the 2 tablets that passed the USP test; the other 4 tablets had cracked coatings. Four of the 6 tablets released a higher percentage of aspirin in the first dissolution medium, much greater than the acceptable limit of 10% (30 mg). On visual inspection, the other 3 comparison batches showed no evidence of cracks in the enteric coating. However, the coating of the later batches (C and D) appeared rougher, or more dimpled and shinier than batch B. The surface texture of batch B appeared to be similar to that of the original batch (A) with cracked coatings. (4 refs.) (Abstract by Kate Gibbons.)

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