DNase liquid solutions
AssigneeGenentech, Inc.
InventorsHak-Kim Chan, Igor Gonda, Steven J. Shire, Suzanne Sin-Mui Lo Weck
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Abstract
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.
Claims17
A process for minimizing thermal aggregation of DNase in a liquid solution comprising:
- a) introducing a DNase aggregation-inhibiting amount of a sugar that is a disaccharide to a solution comprising a human DNase, and
- b) elevating the temperature of said DNase solution to above 37° C.,
- wherein aggregation of said DNase at said elevated temperature is reduced as compared to said DNase in said liquid solution without said DNase aggregation-inhibiting amount of the said sugar.
A DNase solution comprising a human DNase and a DNase aggregation-inhibiting amount of a sugar that is a disaccharide wherein said DNase solution is minimally aggregated when said solution is at a temperature greater than 37° C.
Dependencies are inferred from the claim text.