Examination of Disintegration for Film-coated Niceritrol Tablet Excreted without Disintegration

Abstract

A patient offered that oral administered tablet excreted in stool in the unchanged form. We investigated this film-coated tablet, Perycit® (Niceritrol), by the J.P.XI disintegration test.Although it was broken completely in the J. P. XI first fluid (pH 1.2), it was not broken at all in the J.P.XI second fluid (pH 6.8) or water.We examined its disintegration test in various pH with Mcllvaine buffer solution, and the results were that the time prolonged extremely above pH 5.0.57 kinds of commercial film-coated tablets tested were broken rapidly in the J.P.XI second fluid and water except Perycit®. Perycit® seemed to be used in a peculiar film-coating material and may be not disintegrated in human gastrointestinal fluid because of the resistance of film-coating material to alkali and water.These results suggest that Perycit® should be used carefully to patient with anacidity and such information must be given to users in detail.