| abstract |
The present invention relates to delayed release pharmaceutical compositions comprising linaclotide or a pharmaceutically acceptable salt thereof, and 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 that exhibits delayed release of linaclotide into the lower gastrointestinal tract. Furthermore, the present invention provides a method for treating a disease state by administering these delayed release compositions. Various pathological conditions can be treated using the delayed release composition of the present invention, particularly irritable bowel syndrome (“IBS”) (eg, IBS “IBS-c” with constipation, IBS “IBS-d” with diarrhea) Or mixed IBS with constipation and diarrhea (IBS-m)), constipation (eg, chronic idiopathic constipation), colon cancer, diverticulitis, interstitial cystitis, and gastrointestinal disorders such as abdominal or visceral pain Suitable for treatment. [Selection figure] None |