Spread of Mesalazine Rectal Foam after Single Dose in Mild Ulcer Patients

Abstract

Background: The rectal foam enemas were used for ulcerative colitis of distal regions due to its desired efficacy and less side effects. The spread and persistence of the drug plays a key role in the treatment. Therefore, the objective of the present study is to study the spread and persistence of Salofalk (Mesalazine foam Enema), manufactured by Dr. Falk Pharma GmbH (mesalazine) rectal foam in mild ulcerative colitis patients. Methods: This is an open label, uncontrolled prospective study in ulcerative colitis patients. The patients received 2 g of mesalazine rectal foam (labelled with Tcm99) in two actuations (30 mL). The spread of the radiolabeled formulation was assessed over a period of 4 h by gamma scintigraphy. Results: The formulation was retained by the patients till 4 h imaging period. The foam spread in rectum, sigmoid colon and descending colon. The percentage radioactive dose exposed is more in sigmoid colon compared to rectum and descending colon in 4 h imaging period. The spread of the foam extended till descending colon for two out of 4 patients. Conclusion: The study results are consistent with the previous studies, and it supports the label indication. The obtained data of the present study provides in vivo evidence of the spread of formulation in the desired site of action.