The Effect of Pinholes on the Dissolution Behaviour of Enteric-Coated Acetylsalicylic Acid Tablets

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Abstract
A statistically significant number of enteric-coated acetylsalicylic acid tablets were found to fail the USP Drug Release test. It was demonstrated that failure was caused by pinhole defects in the enteric coating. Fluid would enter the tablets through these defects during the acid resistance stage of testing. Poor performance during the buffer stage of testing was attributed to a failure of the core tablets to disintegrate and undergo dissolution because all disintegration mechanisms had already been exhausted. Pinhole defects were observed to exist primarily in the engraved logos on the tablet faces. A switch to plain-faced tablets resulted in a dramatic reduction in dissolution failures.

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