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Stable, Benzyl Alcohol-free Aqueous Solution Formulations Containing Alpha-type Interferon
专利权人:
Hoffmann-La Roche Inc.
发明人:
Ulla Grauschopf,Michael Adler,Hanns-Christian Mahler,Felix Heise,Susanne Baroth
申请号:
US15467884
公开号:
US20170360891A1
申请日:
2017.03.23
申请国别(地区):
US
年份:
2017
代理人:
摘要:
The present invention provides a stable, isotonic, aqueous solution formulation comprising: (i) 0.1-0.5 mg/mL alpha-type interferon, preferably pegylated alpha-type interferon; (ii) 20 mM Acetate buffer system to maintain a pH of 6.0±0.5; (iii) 5-20 mM L-methionine; (iv) 120-150 mM sodium chloride; (v) 0.01-0.07 percent by weight of a surfactant effective to stabilize the alpha-type interferon, preferably pegylated alpha-type interferon against loss of its activity and (vi) an amount of water for injection sufficient to prepare a solution of the above-listed ingredients.
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