Claims for Patent: 6,776,982

Summary for Patent: 6,776,982

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)
Application Number:	10/016,361
Patent Claims:	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%.