C - Chemistry – Metallurgy – 12 – N
Patent
C - Chemistry, Metallurgy
12
N
C12N 9/96 (2006.01) A61K 38/46 (2006.01) C12N 9/16 (2006.01) C12N 9/22 (2006.01)
Patent
CA 2184581
The present invention relates to the use of calcium ion and/or sugars to minimize thermal aggregation of DNase and to the use of calcium ion to stabilize liquid solutions of DNase, the solutions having a pH of less than neutral. DNase is the active pharmaceutical principle and the solutions may contain other pharmaceutically acceptable excipients making them suitable for pharmaceutical administration. In the first instance, calcium ion/sugar minimizes the effects of thermal aggregation in the solution. In the second aspect, calcium ion stabilizes the lower pH solutions from protein precipitation.
La présente invention concerne d'une part l'utilisation de l'ion calcium et/ou de sucres pour minimiser l'agglomération de l'ADN-ase par effet thermique, et d'autre part l'utilisation de l'ion calcium pour stabiliser les solutions liquides d'ADN-ase, lesquelles solutions ont un pH inférieur au coefficient neutre. L'ADN-ase est le principe pharmaceutique actif, les solutions pouvant contenir d'autres excipients pharmaceutiquement acceptables permettant de les rendre pharmaceutiquement propres à l'administration. En premier lieu, l'approche ion calcium / sucre minimise les effets de l'agglomération thermique dans la solution. En second lieu, l'ion calcium stabilise les solutions à pH bas provenant des précipitations de protéines.
Chan Hak-Kim
Gonda Igor
Shire Steven J.
Weck Susanne Sin-Mui Lo
Dennison Associates
Genentech Inc.
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