Pharmaceutical Products
Pharmaceutical products comprising 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone or a salt thereof, or a hydrate thereof or a solvate thereof as an active ingredient, wherein production of hydrazine is substantially suppressed is provided.
1 . Pharmaceutical products comprising 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone or a salt thereof, or a hydrate thereof or a solvate thereof as an active ingredient provided that an aqueous solution is excluded, wherein production of hydrazine is substantially suppressed.
2 . The pharmaceutical products according to claim 1 , wherein the active ingredient is 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone hydrochloride trihydrate.
3 . The pharmaceutical products according to claim 1 , wherein an amount of the hydrazine produced after storage at 60° C. for 30 days is less than about 0.23% (w/w) based on the active ingredient.
4 . The pharmaceutical products according to claim 1 , wherein an amount of the hydrazine produced after storage at 60° C. for 30 days is not more than about 0.05% (w/w) based on the active ingredient.
5 . The pharmaceutical products according to claim 1 , wherein the active ingredient is dissolved in a non-aqueous solvent.
6 . The pharmaceutical products according to claim 5 , wherein the non-aqueous solvent consists of one or more types of solvents selected from glycerin, propylene glycol, polysorbate, ethanol and polyethylene glycol.
7 . The pharmaceutical products according to claim 1 , which are lyophilized products.
8 . The pharmaceutical products according to claim 7 , which contain a saccharide.
9 . The pharmaceutical products according to claim 7 , which contain a pH stabilizer.
10 . The pharmaceutical products according to claim 7 , which are dissolved upon use.
11 . Pharmaceutical products containing 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone or a salt thereof, or a hydrate thereof or a solvate thereof as an active ingredient, wherein an amount of hydrazine produced after storage of the pharmaceutical products at 60° C. for 30 days is less than about 0.23% (w/w) based on the active ingredient.
12 . The pharmaceutical products according to claim 11 , wherein the active ingredient is 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone hydrochloride trihydrate.
13 . The pharmaceutical products according to claim 11 , wherein the an amount of the hydrazine produced is not more than about 0.05% (w/w) based on the active ingredient.
14 . The pharmaceutical products according to claim 11 , which are non-aqueous solution products, or lyophilized products.
15 . The pharmaceutical products according to claim 14 , wherein non-aqueous solvent of the non-aqueous solution products consist of one or more types of solvents selected from glycerin, propylene glycol, polysorbate, ethanol and polyethylene glycol.
16 . The pharmaceutical products according to claim 14 , wherein the lyophilized products contain a saccharide.
17 . The pharmaceutical products according to claim 14 , wherein the lyophilized products contain a pH stabilizer.
18 . The pharmaceutical products according to claim 14 , wherein the lyophilized products are dissolved upon use.
19 . A method for stabilization of a solution containing 6-[4-(4-pyridylamino)phenyl]-4,5-dihydro-3(2H)-pyridazinone or a salt thereof, or a hydrate thereof or a solvate thereof, which comprises the step of adjusting a pH of the solution within a range of from about 3 to about 7.
20 . The method for stabilization according to claim 19 , wherein the solution contains a pH stabilizer.
21 . The method for stabilization according to claim 19 , wherein the solution contains an isotonic agent.