Method for treating celiac disease

摘要

Enteric compositions comprising one or more tight junction agonists and/or one or more tight junction antagonists are provided. Compositions of the invention may comprise a delayed-release coating disposed over a tight junction agonist and/or tight junction antagonist layer which may be disposed over an inert core. Delayed-release coatings may be substantially stable in gastric fluid and substantially unstable in intestinal fluid, thus providing for substantial release of the tight junction agonist and/or antagonist from the composition in the duodenum or jejunum of the small intestine.

主权项

1. A method for treating a celiac patient, comprising:
administering a peptide having the amino acid sequence of SEQ ID NO:1 to the duodenum of the patient; wherein the peptide is formulated as an oral dosage, delayed-release composition that contains peptide-coated beads having a delayed release coating that is a 1:1 co-polymer of methacrylic acid and ethyl acrylate and which is stable in gastric fluid and unstable in near neutral to alkaline environments so as to release peptide in the duodenum, and wherein at least 70% of the peptide in said beads is released upon exposure for 90 minutes to simulated intestinal fluid having a pH of greater than 5, and wherein the beads contain 0.1 to 0.8% by weight of said peptide.