Stable pharmaceutical composition for the treatment of hypothyroidism, comprises levothyroxine or its salt, and excipients; or diluent(s), disintegrant(s), binder(s), and lubricant(s) or glidant(s)
2023-08-11
专利权人MANKIND PHARMA LTD (MANK-Non-standard)
申请日期2023-08-11
专利号IN202311053836-A
成果简介NOVELTY - Stable pharmaceutical composition comprises 325-1000 mcg levothyroxine or its salt, and one or more excipients; or 325-1000 mcg levothyroxine, 1-99 wt.% diluent(s), 1-50 wt.% disintegrant(s), 0-25 wt.% binder(s), and 1-5 wt.% lubricant(s) or glidant(s), where the particle size of levothyroxine or its salts is D10 1-25 µm. USE - Stable pharmaceutical composition for the treatment of hypothyroidism. No biological data given. ADVANTAGE - The composition is optimal, stable, and safe; and is free of excipient(s) that adversely affect the stability of levothyroxine or its salt. DETAILED DESCRIPTION - An INDEPENDENT CLAIM is included for a kit comprising: pharmaceutical composition comprising levothyroxine and excipients; a desiccant selected from silicon dioxide (silica gel), alumina oxide, a mixture of silica gel and activated carbon, a mixture of silica gel and clay, a mixture of silica alumina and activated carbon; a synthetic zeolite, silica gel, silica alumina, an active carbon, metallic oxide such as calcium oxide, where the pharmaceutical composition has water content less than 5% by weight after storage at 40℃/75% RH for three months.
IPC 分类号A61K-031/195 ; A61K-031/198 ; A61K-009/20 ; B01F-003/18 ; B01F-005/06 ; B01F-005/24
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/20862
专题中国科学院新疆生态与地理研究所
作者单位
MANKIND PHARMA LTD (MANK-Non-standard)
推荐引用方式
GB/T 7714
KUMAR A,MUTHULINGAM C,RAI S K,et al. Stable pharmaceutical composition for the treatment of hypothyroidism, comprises levothyroxine or its salt, and excipients; or diluent(s), disintegrant(s), binder(s), and lubricant(s) or glidant(s). IN202311053836-A[P]. 2023.
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