A transparent complex eye drop containing a carbonic anhydrase inhibitor and timolol, and a method for producing the same.

Abstract

The present invention relates to a transparent complex eye drop containing a carbonic anhydrase inhibitor; timolol or a pharmaceutically acceptable salt thereof; and cyclodextrin or a derivative thereof as a recrystallization inhibitor; and a method for producing the same.

Claims

1. Carbonic anhydrase inhibitor; Timolol or its pharmaceutically acceptable salts; and As a recrystallization inhibitor, cyclodextrin or its derivatives; A transparent complex eye drop containing the following ingredients.

2. The clear complex eye drop according to claim 1, characterized in that the carbonic anhydrase inhibitor is dorzolamide, methazolamide, brinzolamide, dichlorphenamide, acetazolamide, or a pharmaceutically acceptable salt thereof.

3. The transparent complex eye drop according to claim 1, characterized in that the recrystallization inhibitor further comprises an amino acid or a salt thereof.

4. The transparent complex eye drop according to claim 1, characterized in that the transparent complex eye drop maintains a pH of 6.0 to 8.

0.

5. The concentration of the carbonic anhydrase inhibitor is 10 mg / mL to 30 mg / mL. The transparent complex eye drop according to claim 1, characterized in that the concentration of timolol or a pharmaceutically acceptable salt thereof is 1 mg / mL to 10 mg / mL.

6. The transparent complex eye drop according to claim 1, characterized in that the cyclodextrin or its derivative comprises one or more selected from the group consisting of α-cyclodextrin, β-cyclodextrin, γ-cyclodextrin, dimethyl-α-cyclodextrin, dimethyl-β-cyclodextrin, dimethyl-γ-cyclodextrin, hydroxyethyl-α-cyclodextrin, hydroxyethyl-β-cyclodextrin, hydroxyethyl-γ-cyclodextrin, hydroxypropyl-α-cyclodextrin, hydroxypropyl-β-cyclodextrin, hydroxypropyl-γ-cyclodextrin, sulfobutyl ether-α-cyclodextrin, sulfobutyl ether-β-cyclodextrin, and sulfobutyl ether-γ-cyclodextrin.

7. The transparent complex eye drop according to claim 1, characterized in that the concentration of the cyclodextrin or its derivative is 10 mg / mL to 200 mg / mL.

8. The transparent complex eye drop according to claim 1, characterized in that the concentration of the cyclodextrin or its derivative is 100 mg / mL to 130 mg / mL.

9. The transparent complex eye drop according to claim 3, characterized in that the aforementioned amino acid or salt thereof contains one or more selected from the group consisting of arginine, lysine, histidine, aspartic acid, glycine, alanine, valine, carnitine, levocarnitine, proline, leucine, and salts thereof.

10. The transparent complex eye drop according to claim 3, characterized in that the concentration of the amino acid or its salt is 0.1 mg / mL to 10 mg / mL.

11. The transparent complex eye drop according to claim 3, characterized in that the concentration of the amino acid or its salt is 1 mg / mL to 5 mg / mL.

12. The transparent complex eye drop according to claim 1, characterized in that the transparent complex eye drop is for multiple uses or for single use.

13. (a) A step of preparing the first solution by adding cyclodextrin or a derivative thereof to a carbonic anhydrase inhibitor and then stirring; (b) A step of preparing a second solution by adding timolol or a pharmaceutically acceptable salt thereof to the first solution prepared and then stirring; and (c) A step of adjusting the pH of the second solution prepared; A method for producing a transparent complex eye drop containing [the specified ingredient].

14. A method for producing a transparent complex eye drop according to claim 13, characterized in that, in step (b) above, an amino acid or a salt thereof is further added after the addition of timolol or a pharmaceutically acceptable salt thereof.

15. A method for producing a transparent complex eye drop according to claim 13, characterized in that the pH is adjusted to 6.0 to 8.0 in step (c).

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