发明名称 |
LIQUID PHARMACEUTICAL FORMULATIONS OF PALONOSETRON |
摘要 |
The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments. |
申请公布号 |
US2017042807(A1) |
申请公布日期 |
2017.02.16 |
申请号 |
US201615240485 |
申请日期 |
2016.08.18 |
申请人 |
Helsinn Healthcare SA |
发明人 |
Calderari Giorgio;Bonadeo Daniele;Cannella Roberta;Macciocchi Alberto;Miksztal Andrew;Malefyt Thomas;Lee Kathleen M. |
分类号 |
A61K9/08;A61K47/18;A61K47/26;A61K31/473 |
主分类号 |
A61K9/08 |
代理机构 |
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代理人 |
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主权项 |
1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:
palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base; from 0.005 mg/mL to 1.0 mg/mL EDTA; and from 10 mg/mL to 80 mg/mL mannitol, wherein said formulation is stable at 24 months when stored at room temperature. |
地址 |
Lugano / Pazzallo CH |