RELEASE PROFILE OF SALOFALK 750 MG TABLETS

This study determined the release profile of Salofalk 750 mg tablets ( Axcan Pharma), an enteric-coated 5-aminosalicylic acid (5-ASA) prepara tion. Twenty-one ileostomates were divided into two groups and studied . Group 1 consisted of 10 subjects (five males, five females, mean age 39 years) who had a mean length of 65 cm of small bowel resected or o ut of circuit. Group 2 consisted of 11 subjects (eight males, three fe males, mean age 59 years) whose small bowel was intact. Following an o vernight fast and collection of baseline samples, one Salofalk tablet was ingested. Ileostomy effluent and urine were collected for 24 h. Pl asma samples were collected hourly for 6 h, then at 8, 12 and 24 h. Al l subjects ate standardized meals. All samples were stored at -10 degr ees C and 5-ASA and N-ac-5-ASA (a metabolite of 5-ASA) were measured b y high performance liquid chromatography. The mean intestinal transit time was not statistically different between the groups but the mean i leostomy effluent output was higher in group 1 versus group 2 (10.9 ve rsus 13.1 h, P=0.4; 918 versus 606 mL, P=0.05). The mean peak plasma c oncentrations of 5-ASA and N-ac-5-ASA were not significantly different (6.12 and 5.42 mu g/mL, P=0.8, respectively, in group 1 versus 6.75 a nd 6.66 mu g/mL, P=0.8 in group 2). On average, 33.1% of the ingested dose was recovered in the ileostomy effluent in group 1 versus 21.2% i n group 2 (P=0.06) whereas the mean recovery in urine was 40.9% in gro up 1 but 62.9% in group 2 (P=0.001). These results suggest that 5-ASA is released in the small bowel. There was decreased absorption of 5-AS A and increased recovery of 5-ASA in the ileostomy effluent of subject s who had a small bowel resection.