The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Sep. 12, 2023

Filed:

Nov. 02, 2022
Applicant:

Fresenius Kabi Deutschland Gmbh, Bad Homburg, DE;

Inventors:

Gianluca Rinaldi, Monterotondo, IT;

Silvia Fratarcangeli, Ceprano, IT;

Alessandra Del Rio, Rome, IT;

Assignee:
Attorney:
Primary Examiner:
Int. Cl.
CPC ...
A61K 39/395 (2006.01); A61K 9/00 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); C07K 16/24 (2006.01);
U.S. Cl.
CPC ...
A61K 39/39591 (2013.01); A61K 9/0019 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); C07K 16/241 (2013.01); C07K 2317/21 (2013.01); C07K 2317/76 (2013.01);
Abstract

The present invention relates to novel liquid pharmaceutical compositions of adalimumab, which include adalimumab or a biosimilar thereof, an histidine buffering agent such as histidine (or histidine buffer system such as histidine/imidazolium-histidine), and a sugar stabiliser such as trehalose. Such a combination of components furnishes formulations having a stability (e.g. on storage and when exposed to stress) which is comparable to or an improvement upon those known in the art, and with fewer ingredients. Such advances will help adalimumab treatments to become more widely available at lower cost, and prolong the viability of pre-loaded delivery devices (e.g. pre-filled syringes) to reduce unnecessary waste of the drug.


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