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(19)

(11)

2 692 779

(13)

(51)

IPC

A61K31/47(2006-01-01)

A61K47/02(2006-01-01)

A61K47/26(2006-01-01)

A61K47/32(2006-01-01)

A61K47/38(2006-01-01)

A61K9/16(2006-01-01)

(21) (22)

Application

2014139006, 2013-02-27

(24)

Start date

2013-02-27

(22)

Actual filing date

2013-02-27

(45)

Published

2019-06-27

(72)

Inventor

Dokou EleniDzhamzad ShakhlaKaesar Dzhon P. Ml.Favaz MadzhedDas LauraGu Chun-KhojKherter Patrisiya NellIsrani Megkhna DzhajDzhonston Megan M.Knezich DragutinKuzmission Endryu G.Van Khunzhen

(73)

Holder

Verteks Farmasyutikalz Inkorporejted

PHARMACEUTICAL COMPOSITION AND INTRODUCTION THEREOF Russian patent published in 2019 - IPC A61K31/47 A61K47/02 A61K47/26 A61K47/32 A61K47/38 A61K9/16

Abstract RU 2692779 C2

FIELD: pharmaceuticals.

SUBSTANCE: present invention refers to a pharmaceutical composition for treating cystic fibrosis in children younger than 6 years old. Composition contains a solid dispersion containing N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, hydroxypropyl methyl cellulose acetate succinate, sodium lauryl sulphate, mannitol and lactose, sucralose, sodium croscarmellose, colloidal silicon dioxide and magnesium stearate. Mannitol and lactose are presented in weight ratio of 1:3, respectively. Composition does not contain sodium lauryl sulphate anywhere other than the solid dispersion. Composition is presented in the form of a single dosage form containing one or more granules or mini-tablets. Also described is a method of treating or reducing the severity of cystic fibrosis in a child of less than 6 years old using said pharmaceutical composition.

EFFECT: granular composition of the invention is characterized by a satisfactory bioavailability profile and physical stability.

23 cl, 2 dwg, 22 tbl, 22 ex

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RU 2 692 779 C2

Authors

Dokou Eleni

Dzhamzad Shakhla

Kaesar Dzhon P. Ml.

Favaz Madzhed

Das Laura

Gu Chun-Khoj

Kherter Patrisiya Nell

Israni Megkhna Dzhaj

Dzhonston Megan M.

Knezich Dragutin

Kuzmission Endryu G.

Van Khunzhen

Dates

2019-06-27—Published

2013-02-27—Filed