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1. (WO2017153541) PHARMACEUTICAL FORMULATION

Pub. No.:    WO/2017/153541    International Application No.:    PCT/EP2017/055594
Publication Date: Fri Sep 15 01:59:59 CEST 2017 International Filing Date: Fri Mar 10 00:59:59 CET 2017
IPC: A61K 39/395
A61K 9/00
C07K 16/22
A61K 47/18
A61K 9/08
A61K 47/40
Applicants: UCB BIOPHARMA SPRL
Inventors: YATES, Andrew Jeffrey
CLIPSTONE, James Gregory
Title: PHARMACEUTICAL FORMULATION
Abstract:
The invention relates to a liquid pharmaceutical formulation comprising an antibody or antigen- binding fragment thereof, cyclodextrin and methionine. In addition, it relates to a method for reducing precipitation of an antibody or an antigen-binding fragment thereof in a liquid pharmaceutical formulation through addition of methionine and cyclodextrin. In particular, the liquid pharmaceutical formulations comprises an anti-sclerostin antibody, hydroxypropyl-gamma cyclodextrin and methionine and may be used in the treatment of a bone disorder associated with at least one of low bone formation, low bone mineral density, low bone mineral content, low bone mass, low bone quality and low bone strength, and especially for treating osteoporosis. Furthermore, the invention relates to a method of reducing inflammation at injection site in a mammalian subject comprising administering a therapeutically effective amount of a liquid pharmaceutical formulation comprising an antibody or antigen-binding fragment thereof, cyclodextrin and methionine.