Gluten content in pharmaceuticals marketed in the Gaza Strip

Abstract

Gluten is a wheat protein which could trigger an immune-mediated inflammatory response causing Celiac disease. Pharmaceuticals are possible source of gluten due to excipients like wheat starch. This study examined some pharmaceuticals (non-prescription and prescription type) on gluten and partially hydrolyzed gluten fragments content using sandwich and competitive ELISA techniques, respectively. Partially hydrolyzed gluten fragments were detected in ca. 37% of tested samples (Total: 38). Only 5 samples had gluten concentration above 20 ppm. None of the pharmaceuticals had detectable levels of glutens upon sandwich ELISA application. Oral administration of four dosage forms at recommended doses provided celiacs with a daily gluten intake exceeding the daily tolerance limit. Excipients in patient information leaflet were absent in most cases. The findings confirmed that pharmaceuticals could increase the burdens of celiac patients. Accordingly, regular examination of pharmaceuticals on gluten content is advised. Further studies are recommended that would include a larger sample size, and analytical methods to determine gluten in pharmaceuticals should be developed. Registration agencies in the Gaza Strip should apply updated regulations of excipients.