Freeze-dried composition containing a 2-dimethylamino etoposide derivative
AssigneeNippon Kayaku Kabushiki Kaisha
InventorsKazuo Ohtsuki, Taka'aki Ohkuma
Life of this patent
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Abstract
The present invention relates to a freeze-dried preparation comprising (1) about 5 to about 50 W/W% of a non-volatile acid and/or a salt thereof, (2) about 10 to about 95 W/W% of 4-O-(2-deoxy-2-dimethylamino-4,6-O-ethylidene-.beta.-D-glucopyranosyl)-4'- demethyl-4-epipodophyllotoxin hydrochloride and (3) 0 to about 85 W/W% of at least one sugar as a stabilizer.
Claims7
A freeze-dried preparation consisting essentially of (1) about 5 to about 50 W/W% of a combination of a non-volatile acid and a pharmaceutically acceptable salt thereof selected from the group consisting of phosphoric acid with its pharmaceutically acceptable salt, an oxycarboxylic acid having 6 carbon atoms with its pharmaceutically acceptable salt, a dicarboxylic acid having 4 carbon atoms with its pharmaceutically acceptable salt, and an aminoacetic acid with its pharmaceutically acceptable salt, (2) about 15 to about 80 W/W% of 4-O-(2-deoxy-2-dimethylamino-4,6-O-ethylidene-.beta.-D-glucopyranosyl)-4'- demethyl-4-epipodophyllotoxin hydrochloride and (3) at least one sugar as a stabilizer, such that said freeze-dried preparation, upon reconstitution with water, does not crystallize and has a pH not less than about 3 but less than about 5.
A freeze-dried preparation consisting essentially of (1) about 15 to about 35 W/W% of phosphoric acid and an alkali metal salt thereof, (2) about 15 to about 80 W/W% of 4-O-(2-deoxy-2-dimethylamino-4,6-O-ethylidene-.beta.-D-glucopyranosyl)-4'- demethyl-4-epipodophyllotoxin hydrochloride and (3) 0 to about 70 W/W% of lactose as a stabilizer, such that said freeze-dried preparation, upon reconstitution with water, does not crystallize and has a pH not less than about 3 but less than about 5.
A freeze-dried preparation consisting essentially of (1) about 20 to about 30 W/W% of phosphoric acid and an alkali metal salt thereof, (2) about 30 to about 50 W/W% of 4-O-(2-deoxy-2-dimethylamino-4,6-O-ethylidene-.beta.-D-glucopyranosyl)-4'- demethyl-4-epipodophyllotoxin hydrochloride and (3) about 30 to about 50 W/W% of lactose as a stabilizer, such that said freeze-dried preparation, upon reconstitution with water, does not crystallize and has a pH not less than about 3 but less than about 5.
A freeze-dried preparation consisting essentially of (1) about 0.1 to about 5 parts by weight of a combination of a non-volatile acid and a pharmaceutically acceptable salt thereof selected from the group consisting of phosphoric acid with its pharmaceutically acceptable salt, an oxycarboxylic acid having 6 carbon atoms with its pharmaceutically acceptable salt, a dicarboxylic acid having 4 carbon atoms with its pharmaceutically acceptable salt, and an aminoacetic acid with its pharmaceutically acceptable salt, (2) 1 part by weight of 4-O-(2-deoxy-2-dimethylamino-4,6-O-ethylidene-.beta.-D-glucopyranosyl)-4'- demethyl-4-epipodophyllotoxinhydrochloride and (3) about 0.1 to about 10 parts by weight of at least one sugar as a stabilizer, such that said freeze-dried preparation, upon reconstitution with water, does not crystallize and has a pH not less than about 3 but less than about 5.
Dependencies are inferred from the claim text.