Vertex Pharmaceuticals, Inc.

Sunovion Pharmaceuticals Inc.

Sumitomo Pharma America, Inc.

Shahla Jamzad

Chong-Hui Gu

Patricia Nell Hurter

Eleni Dokou

Majed Fawaz

Dragutin Knezic

John P Caesar, Jr

Andrew G Kuzmission

Meghan M Johnston

Hongren Wang

Meghna Jai Israni

Laura Das

Haitao Zhang

Andrea Bauer

Michael Joseph Sizensky

Robert Joseph Prytko

Xiaoxia Chen

Harold Scott Wilkinson

Kostas Saranteas

Nandkumar Nivritti Bhogle

John P Caesar

The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Pharmaceutical composition and administrations thereof

Provided are salts of (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine and various of crystal forms thereof, and compositions, medicaments, pharmaceutically acceptable formulations thereof, and methods of making same. In addition, provided are compounds comprising specific particle size distributions of crystalline (S)-(4,5-dihydro-7H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine HCl and methods of making and modulating the particle size distributions.

Salts, crystal forms, and production methods thereof

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Belmont, MA, United States of America

Shahla Jamzad