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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Authors
Dates
2024-10-03—Published
2013-05-17—Filed