Gastrointestinal Blood Loss Caused by Controlled-Release and Conventional Acetylsalicylic Acid Tablets

Abstract

Gastrointestinal blood loss has been studied following oral administration of the novel controlled-release acetylsalicylic acid tablet preparation Acetard® and the instant-release acetylsalicylic acid tablet Magnecyl (Ph. Nord. 63). Acetard contains micro-encapsulated acetylsalicylic acid crystals having an in vitrorelease time of approximately 4 hours. The investigation was carried out as a two-part, randomized cross-over trial, and with a test dosage of either 1 g×4 or 2 g×2 per day, given to 10 and 14 male students, respectively, during two 5-day periods separated by a one week interval. The dosage of the plain formulation was maintained at 1 g×4 daily in both parts of the investigation. Faeces were collected every 24 hours throughout the trial, covering a total of 4 weeks. Blood loss was measured using the ⁵¹Cr labelling technique. Acetard was found to cause statistically significantly less gastrointestinal blood loss as compared with the plain formulation, irrespective of whether Acetard® was given twice or four times a day.