PROCESS OF PREPARING PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CFTR MEDIATED DISEASES

• Main Authors: SMITH, DAVID, HURTER, PATRICIA NELL, WARMAN, MARTIN PAUL, NADIG, DAVID E, SWINNEY, KELLY ANN, THOMAS, VANCE HAYDEN
• Format: Patent
• Language: English; French
• Published: 25.10.2022
• Subjects: BABY COMFORTERS; CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICALPURPOSES; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; DEVICES FOR RECEIVING SPITTLE; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGINGPHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL ORADMINISTERING FORMS; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

Processes of preparing pharmaceutical compositions comprising 3-(6-(1-(2,2- difluorobenzo[d][1,3] dioxol-5 -yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (Compound 1) in Form I and a solid dispersion comprising substantially amorphous N-(5- hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-lH-quinoline-3-carboxamide (Compound 2), methods of treating, lessening the severity of, or symptomatically treating CFTR mediated diseases, such as cystic fibrosis, methods of administering, and kits thereof are disclosed. La présente invention concerne des procédés de préparation de compositions pharmaceutiques comprenant de l'acide 3-(6-(1-(2,2- difluorobenzo[d][1,3] dioxol-5 -yl) cyclopropanecarboxamido)-3-méthylpyridin-2-yl)benzoïque (composé 1) dans la forme I et une dispersion solide comprenant du N-(5- hydroxy-2,4-ditert-butyl-phényl)-4-oxo-lH-quinoline-3-carboxamide (composé 2) sensiblement amorphe, des méthodes de traitement, réduisant la gravité de, ou traitant de façon symptomatique des maladies à médiation assurée par le CFTR, telles que la fibrose kystique, des méthodes d'administration, et des kits associés.