Composition for injection
The present disclosure relates to a composition for injection, which comprises a pharmaceutically acceptable salt of a compound represented by Formula 1 and one or more selected from mannitol, trehalose, lactose and glucose as a stabilizing agent, having improved stability.
1. An injectable composition comprising:
a pharmaceutically acceptable salt of a compound represented by the following Formula 1; and
at least one stabilizing agent selected from the group consisting of mannitol, trehalose, lactose and glucose:
2. The injectable composition according to claim 1 , wherein the pharmaceutically acceptable salt of the compound represented by Formula 1 is a compound represented by the following Formula 2:
3. The injectable composition according to claim 1 , wherein the stabilizing agent is mannitol or trehalose.
4. The injectable composition according to claim 1 , wherein the stabilizing agent is present in an amount of 0.5 to 3.0 parts by weight with respect to 1 part by weight of the pharmaceutically acceptable salt of the compound represented by Formula 1.
5. The injectable composition according to claim 1 , wherein the pH of the injectable composition ranges from 3.0 to 5.0.
6. The injectable composition according to claim 1 , wherein the injectable composition is in the form of liquid or dried powder.
7. The injectable composition according to claim 1 , wherein the injectable composition further comprises at least one ingredient selected from the group consisting of an isotonic agent, a buffer solution, an osmotic agent and a pH-controlling agent.
8. The injectable composition according to claim 2 , wherein the stabilizing agent is mannitol or trehalose.
9. The injectable composition according to claim 2 , wherein the stabilizing agent is present in an amount of 0.5 to 3.0 parts by weight with respect to 1 part by weight of the pharmaceutically acceptable salt of the compound represented by Formula 1.
10. The injectable composition according to claim 2 , wherein the pH of the injectable composition ranges from 3.0 to 5.0.
11. The injectable composition according to claim 2 , wherein the injectable composition is in the form of liquid or dried powder.
12. The injectable composition according to claim 2 , wherein the injectable composition further comprises at least one ingredient selected from the group consisting of an isotonic agent, a buffer solution, an osmotic agent and a pH-controlling agent.
13. A method for preventing or treating a disease mediated by an acid pump antagonistic activity, the method comprising administering the injectable composition according to claim 1 to a patient.
14. The method according to claim 13 , wherein the disease mediated by an acid pump antagonistic activity is at least one gastrointestinal disease selected from the group consisting of a gastroesophageal disease, a gastroesophageal reflux disease, a peptic ulcer, a gastric ulcer, a duodenal ulcer, an ulcer induced by NSAID, a gastritis, a Helicobacter pylori infection, a dyspepsia, a functional dyspepsia, a Zollinger-Ellison syndrome, a nonerosive reflux disease (NERD), a visceral referred pain, a purosis, a nausea, an esophagitis, a dysphagia, a salivation, an airway lesion and an asthma.
15. A method of administering the injectable composition according to claim 1 , comprising administering the injectable composition to a patient.