Room temperature stable injectable solution for injection of Abaloparatide, comprises Abaloparatide, and stabilizer of L-methionine, disodium Ethylenediamine tetraacetic acid, D-alpha-tocopheryl polyethylene glycol succinate, hydroxypropyl betadex, mannitol, S-methyl-L- cysteine or its mixture
2023-08-04
专利权人PRECISE BIOPHARMA PVT LTD (PREC-Non-standard)
申请日期2023-08-04
专利号IN202422047990-A
成果简介NOVELTY - Room temperature stable injectable solution comprises 0.25-5 mg/ml Abaloparatide and stabilizer selected from 0.1-10 mg/ml 5 L-methionine, 0.1-4 mg/ml disodium Ethylenediamine tetraacetic acid (EDTA), 5-100 mg/ml D-alpha-tocopheryl polyethylene glycol succinate, 50-500 mg/ml hydroxypropyl betadex, 5-100 mg/ml mannitol, 0.1-10 mg/ml S-methyl-L- cysteine or its mixture. The solution is stable for at least 6 months when stored at 25 °C temperature and 60 % relative humidity, where the total impurities of the solution are not more than 2 %. The single maximum impurity is not more than 1 % after 6 months when stored at 25 °C temperature and 60 % relative humidity. USE - Room temperature stable injectable solution for injection of Abaloparatide. ADVANTAGE - The solution is stable at room temperature which overcomes the limitations of the currently marketed formulation.
IPC 分类号A61K-038/29 ; A61K-047/10 ; A61K-009/00 ; A61K-009/19 ; A61P-017/00
国家印度
专业领域医药卫生
语种英语
成果类型专利
文献类型科技成果
条目标识符http://119.78.100.226:8889/handle/3KE4DYBR/13168
专题中国科学院新疆生态与地理研究所
作者单位
PRECISE BIOPHARMA PVT LTD (PREC-Non-standard)
推荐引用方式
GB/T 7714
KATARIYA P A,PATEL N C,PAWAR S S,et al. Room temperature stable injectable solution for injection of Abaloparatide, comprises Abaloparatide, and stabilizer of L-methionine, disodium Ethylenediamine tetraacetic acid, D-alpha-tocopheryl polyethylene glycol succinate, hydroxypropyl betadex, mannitol, S-methyl-L- cysteine or its mixture. IN202422047990-A[P]. 2023.
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