US 12,226,463 B2
Pharmaceutical composition, package and method for producing the same
Mine Higuchi, Tokyo (JP)
Assigned to SEIKAGAKU CORPORATION, Tokyo (JP)
Filed by SEIKAGAKU CORPORATION, Tokyo (JP)
Filed on Apr. 11, 2023, as Appl. No. 18/133,168.
Application 18/133,168 is a continuation of application No. 16/975,546, granted, now 11,648,299, previously published as PCT/JP2019/007437, filed on Feb. 27, 2019.
Claims priority of application No. 2018-035884 (JP), filed on Feb. 28, 2018.
Prior Publication US 2023/0263871 A1, Aug. 24, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/51 (2006.01); A61K 9/19 (2006.01)
CPC A61K 38/51 (2013.01) [A61K 9/19 (2013.01); C12Y 402/02004 (2013.01)] 17 Claims
 
1. A method for producing a package comprising a pharmaceutical composition, 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 a 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.