A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 47/48 (2006.01) A61K 9/19 (2006.01) A61K 38/21 (2006.01) A61K 47/26 (2006.01)
Patent
CA 2324467
The present invention provides formulations that prevent loss and damage of PEG-interferon alpha conjugates during and following lyophilization. The formulations of the present invention protect PEG-interferon alpha conjugates from loss and degradation during the lyophilization process, as well as degradation during subsequent storage. The formulations of the present invention are suitable for protection of PEG-interferon alpha conjugates from various types of degradation, including, but not limited to loss of biological activity and changes in the degree and/or nature of conjugation. A preferred PEG-interferon alpha conjugate protectable in the formulations of the present invention is an interferon alpha-2b-polyethylene glycol (12,000) conjugate.
L'invention concerne des formulations permettant d'éviter la perte et la détérioration de conjugués de PEG et d'alpha-interféron pendant et après la lyophilisation. Ces formulations protègent les conjugués de PEG et d'alpha-interféron contre la perte et la dégradation pendant le processus de lyophilisation, ainsi que contre la dégradation pendant la conservation ultérieure. Ces formulations permettent de protéger ces conjugués contre différents types de dégradation, y compris, sans y être limitées, la perte d'activité biologique et des modifications du degré et/ou de la nature de la conjugaison. Un conjugué préféré de PEG et d'alpha-interféron pouvant être protégé par ces formulations consiste en un conjugué d'alpha-interféron-2b-polyéthylène glycol (12.000).
Ogilvy Renault Llp/s.e.n.c.r.l.,s.r.l.
Schering Corporation
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