Vertex Pharmaceuticals, Inc.

Ironwood Pharmaceuticals, Inc.

Forest Laboratories Holdings Limited

Alfredo Grossi

Peter D J Grootenhuis

Gregor Zlokarnik

Martyn Botfield

Christopher Young

Patricia Nell Hurter

William Rowe

Marinus Jacobus Verwijs

Kirk Raymond Dinehart

Kirk Overhoff

Mahendra G Dedhiya

Angelika Fretzen

Steven Richard Witowski

Yun Mo

Hong Zhao

Christopher R Young

Harvey Schneier

Bernard Joseph Lavins

Fredrick F Van Goor

Jeffrey Johnston

The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

Pharmaceutical composition and administrations thereof

Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr ('linaclotide'; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration

The present invention relates to stable compositions comprising linaclotide, as well as to various methods and processes for the preparation and use of the compositions.

Formulations comprising linaclotide

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Somerville, MA, United States of America

Alfredo Grossi