| abstract |
PROBLEM TO BE SOLVED: To provide a modified or targeted release preparation of linaclotide. The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or a pharmaceutically acceptable salt thereof, as well as various methods and processes for the preparation and use of the compositions. The present invention relates to a stable solid oral dosage form of linaclotide showing delayed release of linaclotide into the lower gastrointestinal tract. Furthermore, the present invention provides a method for treating a pathological condition by administering these delayed release compositions. Various pathological conditions can be treated with the delayed release composition of the present invention, but in particular irritable bowel syndrome (“IBS”) (eg, IBS “IBS-c” with constipation, IBS “IBS-d” with diarrhea. , Or mixed IBS "IBS-m" with constipation and diarrhea), constipation (eg, chronic idiopathic constipation), colon cancer, irritable bowel syndrome, irritable bowel syndrome, and gastrointestinal disorders such as abdominal or visceral pain Suitable for treatment. [Selection diagram] None |