GLP -1 peptide composition and use thereof

Abstract

Pharmaceutical compositions of GLP-1 peptides comprising citric acid, their preparation and use, kits comprising such compositions and their use are provided. The pharmaceutical composition comprises the GLP-1 peptide, a buffering agent, an osmotic pressure regulator and / or an antioxidant, enhances the physicochemical and biological activity stability of the GLP-1 peptide, and does not cause pain feeling to a subject, so that the pharmaceutical composition suitable for clinical one-time injection use is prepared. The pharmaceutical composition can effectively prevent the effective component GLP-1 peptide from losing efficacy due to various factors such as degradation and oxidation, so that the pharmaceutical composition is convenient to transport, store for a long time and use clinically.

Description

(19) State Intellectual Property Office (12) Invention Patent Application (10) Application Publication Number (43) Application Publication Date (21) Application Number 202480064019.4 (22) Application Date 2024.10.09 (66) Domestic Priority Data 202311299125.4 2023.10.09 CN 202410655994.4 2024.05.24 CN (85) PCT International Application Entering National Phase Date 2026.04.03 (86) PCT International Application Application Data PCT / CN2024 / 123787 2024.10.09 (87) PCT International Application Publication Data WO2025 / 077751 ZH 2025.04.17 (71) Applicant Gan & Lee Pharmaceuticals Co., Ltd. Address 101109 No. 8, Nanfeng West Road, Huoxian Town, Tongzhou District, Beijing (72) Inventors: Wang Zaiyu, Peng Yu, Qu Jia (51) Int.Cl. A61K 38 / 26 (2006.01) A61K 9 / 08 (2006.01) A61K 47 / 10 (2006.01) C07K 14 / 605 (2006.01) A61P 3 / 10 (2006.01) (54) Invention Title: GLP-1 Peptide Composition and Its Use (57) Abstract: This invention provides a pharmaceutical composition containing a GLP-1 peptide with citric acid, its preparation and use, a kit containing such a composition and its use. The pharmaceutical composition, comprising a GLP-1 peptide, a buffer, an osmotic regulator, and / or an antioxidant, enhances the stability of the physicochemical and biological activities of the GLP-1 peptide without causing pain to the subject, thereby preparing a pharmaceutical composition suitable for single clinical injection. This pharmaceutical composition effectively prevents the active ingredient GLP-1 peptide from becoming ineffective due to degradation, oxidation, and other factors, thus facilitating transportation, long-term storage, and clinical use. CN 122228101 A 2026.06.16 CN 1 22 22 81 01 A