HIGHLY CONCENTRATED FORMULATIONS OF MONOCLONAL ANTIBODIES Russian patent published in 2024 - IPC A61K39/395 A61K9/10 A61K47/14 A61K47/26 

Abstract RU 2827884 C2

FIELD: medicine; pharmaceutics.

SUBSTANCE: disclosed is a suspension formulation for treating a disease or disorder, comprising a spray-dried monoclonal antibody in concentration of 200 to 500 mg/ml suspended in a non-aqueous suspension vehicle, where viscosity of filler for suspension is less than 20 cP at 25 °C and where the non-aqueous filler for the suspension contains ethyl lactate. Group of inventions also relates to a device for subcutaneous administration containing said composition, a method of producing said device and an embodiment of said suspension formulation, wherein the antibody is a full-length human IgG1 monoclonal antibody.

EFFECT: invention provides a highly concentrated composition with low viscosity.

24 cl, 10 dwg, 4 tbl

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RU 2 827 884 C2

Authors

Armstrong, Nicholas J.

Bowen, Mayumi N.

Maa, Yuh-Fun

Dates

2024-10-03Published

2013-05-17Filed