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|Title:||Autoclavable pharmaceutical compositions containing a chelating agent|
|Abstract:||Disclosed are ophthalmic compositions comprising ketotifen and pharmaceutically acceptable salts thereof, as well as methods for making such compositions.|
|Inventor(s):||Kis; Gyorgy Lajos (Triboltingen, CH), Adam; Marcia Johanna (Gisikon, CH), Fetz; Andrea (Wetzikon, CH)|
|Assignee:||Novartis AG (Basel, CH)|
1. An ophthalmic pharmaceutical composition consisting essentially of 0.0345% ketotifen hydrogen fumarate, 2.125% glycerol, 0.01% benzalkonium chloride and water.
2. The composition according to claim 1 wherein the pH is between about 5.18 and about 5.32.
3. The composition according to claim 1 wherein the osmolality is about 240 milliosmoles.
4. The composition according to claim 2 wherein the osmolality is about 240 milliosmoles.
5. A method for making an ophthalmic pharmaceutical composition, comprising admixing the non-aqueous components ketotifen hydrogen fumarate, glycerol, and benzalkonium chloride with water such that a final concentration of the non-aqueous components is 0.0345% ketotifen hydrogen fumarate, 2.125% glycerol, and 0.01% benzalkonium chloride.
6. The method according to claim 5 wherein the pH of the composition is between about 5.18 and about 5.32.
7. The method according to claim 5 wherein the osmolality of the composition is about 240 milliosmoles.
8. The method according to claim 6 wherein the osmolality is about 240 milliosmoles.
9. The method according to claim 5 wherein the amount of degradation products in said composition is about 0.03%.
10. The composition according to claim 1 wherein the amount of degradation products in said composition is about 0.23%.
11. The composition according to claim 1 wherein the amount of degradation products in said composition is about 0.03%.
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