Title (en)

PHARMACEUTICAL COMBINATION COMPOSITION COMPRISING COMPLEX FORMULATIONS OF IVACAFTOR AND LUMACAFTOR AND THEIR SALTS AND DERIVATIVES, PROCESS FOR THEIR PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

Title (de)

PHARMAZEUTISCHE KOMBINATIONSZUSAMMENSETZUNG MIT KOMPLEXEN FORMULIERUNGEN VON IVACAFTOR UND LUMACAFTOR UND IHREN SALZE UND DERIVATEN, VERFAHREN ZU DEREN HERSTELLUNG UND PHARMAZEUTISCHE ZUSAMMENSETZUNGEN DAMIT

Title (fr)

COMPOSITION PHARMACEUTIQUE COMBINÉE COMPRENANT DES FORMULATIONS COMPLEXES D'IVACAFTOR ET DE LUMACAFTOR AINSI QUE LEURS SELS ET DÉRIVÉS, PROCÉDÉS POUR LEUR PRÉPARATION, ET COMPOSITIONS PHARMACEUTIQUES LES CONTENANT

Publication

EP 3448384 A1 20190306 (EN)

Application

EP 17726698 A 20170425

Priority

• HU P1600271 A 20160425
• IB 2017052374 W 20170425

Abstract (en)

[origin: WO2017187340A1] The invention is directed to a pharmaceutical combination composition comprising stable complexes with controlled particle size, increased apparent solubility and increased dissolution rate comprising as active compound Ivacaftor and Lumacaftor, their salts, or derivatives thereof, which is useful in the treatment of cystic fibrosis transmembrane conductance regulator (CFTR) mediated disease. More specifically, the pharmaceutical composition comprising the complexes of the present invention possess instantaneous redispersibility, increased apparent solubility and permeability, no observable food effect which deliver the opportunity of precise dosing and ease of administration of the reconstituted complex in solution form. The invention also relates to methods of formulating and manufacturing complexes according to the invention, pharmaceutical compositions containing it, its uses and methods of treatment using the complex and its compositions.

IPC 8 full level

A61K 31/47 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 31/44 (2006.01); A61K 31/443 (2006.01); A61K 47/32 (2006.01); A61K 47/34 (2017.01); A61K 47/38 (2006.01); A61P 1/00 (2006.01); A61P 3/06 (2006.01); A61P 7/00 (2006.01); A61P 11/00 (2006.01); A61P 19/00 (2006.01); A61P 25/00 (2006.01)

CPC (source: EP HU)

A61K 9/0053 (2013.01 - EP); A61K 9/145 (2013.01 - HU); A61K 9/146 (2013.01 - HU); A61K 9/1635 (2013.01 - EP); A61K 9/1641 (2013.01 - EP); A61K 9/1652 (2013.01 - EP); A61K 31/44 (2013.01 - EP); A61K 31/443 (2013.01 - EP); A61K 31/47 (2013.01 - EP); A61K 31/4709 (2013.01 - HU); A61K 31/4747 (2013.01 - HU); A61K 47/00 (2013.01 - HU); A61K 47/32 (2013.01 - EP); A61K 47/34 (2013.01 - EP); A61K 47/38 (2013.01 - EP); A61P 1/00 (2018.01 - EP); A61P 1/10 (2018.01 - EP); A61P 1/16 (2018.01 - EP); A61P 1/18 (2018.01 - EP); A61P 3/06 (2018.01 - EP); A61P 3/10 (2018.01 - EP); A61P 5/00 (2018.01 - EP); A61P 5/14 (2018.01 - EP); A61P 5/18 (2018.01 - EP); A61P 7/00 (2018.01 - EP); A61P 9/00 (2018.01 - EP); A61P 11/00 (2018.01 - EP); A61P 11/02 (2018.01 - EP); A61P 11/06 (2018.01 - EP); A61P 13/02 (2018.01 - EP); A61P 15/00 (2018.01 - EP); A61P 17/00 (2018.01 - EP); A61P 17/10 (2018.01 - EP); A61P 19/00 (2018.01 - EP); A61P 21/02 (2018.01 - EP); A61P 25/00 (2018.01 - EP); A61P 25/08 (2018.01 - EP); A61P 25/14 (2018.01 - EP); A61P 25/16 (2018.01 - EP); A61P 25/28 (2018.01 - EP); A61P 43/00 (2018.01 - EP)

C-Set (source: EP)

1. A61K 31/47 + A61K 2300/00
2. A61K 31/44 + A61K 2300/00
3. A61K 31/443 + A61K 2300/00

Designated contracting state (EPC)

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

Designated extension state (EPC)

BA ME

DOCDB simple family (publication)

WO 2017187340 A1 20171102; WO 2017187340 A4 20171228; AU 2017256184 A1 20181213; CA 3022203 A1 20171102; CN 109475546 A 20190315; EP 3448384 A1 20190306; HU P1600271 A2 20171030; IL 262494 A 20181231; JP 2019514898 A 20190606

DOCDB simple family (application)

IB 2017052374 W 20170425; AU 2017256184 A 20170425; CA 3022203 A 20170425; CN 201780039649 A 20170425; EP 17726698 A 20170425; HU P1600271 A 20160425; IL 26249418 A 20181021; JP 2018555738 A 20170425