Pharmaceutical composition, package and method for producing the same
AssigneeSeikagaku Corporation
InventorMine HIGUCHI
Life of this patent
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Abstract
A pharmaceutical composition containing a lyophilized saccharide-degrading enzyme having excellent titer, and a package containing the pharmaceutical composition. The pharmaceutical composition is a unit dose formulation containing a lyophilized saccharide-degrading enzyme with a titer of not less than 0.3 unit/μg as an active ingredient, and contains the saccharide-degrading enzyme in an amount of not less than 2 μg and not more than 6 μg.
Claims15
A method for producing a pharmaceutical composition contained in a container, the method comprising:
- putting a solution comprising not less than 2.5 μg and not more than 5 μg of a saccharide degrading enzyme into the container;
- and
- lyophilizing the solution to obtain a unit dose of the pharmaceutical composition,
- wherein the saccharide-degrading enzyme is chondroitinase ABC,
- wherein a water content of the pharmaceutical composition is not more than 2% (w/w), and
- wherein the pharmaceutical composition comprises the saccharide-degrading enzyme having a titer of not less than 0.34 unit/μg and not more than 0.5 unit/μg.
A method for producing a pharmaceutical composition contained in a container, the method comprising:
- putting a solution comprising not less than 2.5 μg and not more than 5 μg of a saccharide degrading enzyme into the container,
- lyophilizing the solution to obtain a unit dose of the pharmaceutical composition, and
- encapsulating an inert gas in the container,
- wherein:
- the saccharide-degrading enzyme is chondroitinase ABC, a water content of the pharmaceutical composition is not more than 2% (w/w),
- the pharmaceutical composition comprises the saccharide-degrading enzyme having a titer of not less than 0.34 unit/μg and not more than 0.5 unit/μg and has a storage stability for the duration of not less than 12 months at 5° C.±3° C., and a pH of the solution containing the saccharide-degrading enzyme put into the container is in a range of 6.5 to 7.5.
Dependencies are inferred from the claim text.