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Stable Protein Formulations Comprising a Molar Excess of Sorbitol
专利权人:
BIOCON LTD.;MYLAN GMBH
发明人:
Kala CHANDRAMOULI,Rohan PAI
申请号:
US15303881
公开号:
US20170028063A1
申请日:
2015.04.16
申请国别(地区):
US
年份:
2017
代理人:
摘要:
A stable pharmaceutical formulation comprising a protein of interest, sorbitol and polyethylene glycol (PEG). The sorbitol and protein is present in a molar ratio of 550 to 700 mole of sorbitol: 1 mole of protein and the PEG to protein is present in the molar ratio of 2-50:1. The formulation optionally comprising buffer. The formulation in lyophilised form is stable for at least 4 years at 2-8° C. Also provided is a process for preparing the composition and a pharmaceutical kit comprising the same.
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