US 11,980,655 B2
Methods of treatment with stable liquid formulations of glucagon-like peptide 1 or analogues thereof
Andrea Hawe, Munich (DE); Eva Keilhauer, Munich (DE); Olimpia Popko, Munich (DE); Enda Kenny, Killiney (IE); and Richard Warburg, St. Thomas, VI (US)
Assigned to Rose Pharma Inc., Virginia Beach, VA (US)
Filed by Rose Pharma Inc., Virginia Beach, VA (US)
Filed on May 28, 2021, as Appl. No. 17/334,419.
Application 17/334,419 is a division of application No. 17/109,828, filed on Dec. 2, 2020, granted, now 11,058,748.
Claims priority of application No. 1917723 (GB), filed on Dec. 4, 2019.
Prior Publication US 2021/0283226 A1, Sep. 16, 2021
Int. Cl. A61K 38/26 (2006.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01)
CPC A61K 38/26 (2013.01) [A61K 47/183 (2013.01); A61K 47/26 (2013.01)] 18 Claims
 
1. A method of treating a disorder or condition in which administration of a GLP-1 or a GLP-1 analogue is indicated, the method comprising administering to a subject having said disorder or condition a liquid pharmaceutical formulation selected from the group consisting of:
a. a liquid pharmaceutical formulation comprising a GLP-1 analogue having an amino acid sequence as set forth in SEQ ID NO:3, wherein the GLP-1 analogue is at a concentration of from 100 μg/ml to 1 mg/ml and wherein the liquid pharmaceutical formulation comprises histidine-HCl at a concentration of 10 mM, mannitol at a concentration of 275 mM, methionine at a concentration of 10 mM and polysorbate 20 at a concentration of 0.02%, and;
b. a liquid pharmaceutical formulation comprising a GLP-1 analogue having an amino acid sequence as set forth in SEQ ID NO:3, wherein the GLP-1 analogue is at a concentration of from 100 μg/ml to 1 mg/ml and wherein the liquid pharmaceutical formulation comprises histidine-HCl at a concentration of 10 mM, sucrose at a concentration of 233 mM (8%), methionine at a concentration of 10 mM and polysorbate 20 at a concentration of 0.02%.