Compositions and methods for storage stable ophthalmic drugs
AssigneeLenz Therapeutics Operations, Inc.
InventorGerald HORN
Life of this patent
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Abstract
The present invention is related to methods of stabilizing an ophthalmic drug by adding a surfactant and a viscosity enhancer to the ophthalmic drug to create a composition wherein the composition has a viscosity of about 25 centipoise or less at a shear rate of 1/1000 per second at 25 degrees Celsius and a viscosity of about 70 centipoise or more at shear rate of 1 per second at 25 degrees Celsius, filling the composition into a container; and storing the container at a temperature from about 2 degrees Celsius to about 25 degrees Celsius. The present invention is further directed to a container prepared by the methods of the present invention.
Claims20
-22. (canceled)
A method of treating presbyopia in a human, comprising:
- (a) storing an aqueous ophthalmological composition comprising aceclidine at a concentration from about 0.25% to about 4.0% w/v, mannitol at a concentration from about 2.0% to about 4.0% w/v, and water, in a vial at a temperature from about 2 degrees Celsius to about 8 degrees Celsius, wherein w/v denotes weight by total volume of the aqueous ophthalmological composition, and wherein the vial comprises a cap and a headspace between the aqueous ophthalmological composition and the cap, wherein the cap prevents the aqueous ophthalmological composition from exiting the vial when stored;
- and
- (b) administering two drops of the stored aqueous ophthalmological composition from the vial to each eye of the human with presbyopia, wherein administration of two drops to each eye provides near vision improvement for about 10 hours;
- wherein the aqueous ophthalmological composition lacks a cycloplegic;
- wherein when the vial is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 7 months, the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the composition comprised at the onset of storing.
A method of treating presbyopia in a human, comprising:
- (a) storing an aqueous ophthalmological composition comprising aceclidine, mannitol, hydroxypropyl methylcellulose (HPMC) and polysorbate 80 in a vial at a temperature from about 2 degrees Celsius to about 8 degrees Celsius, wherein the vial comprises a cap and a headspace between the aqueous ophthalmological composition and the cap, wherein the cap prevents the aqueous ophthalmological composition from exiting the vial when stored;
- and
- (b) administering two drops of the stored aqueous ophthalmological composition to each eye of the human with presbyopia, wherein administration of two drops to each eye produces near vision improvement for about 10 hours;
- wherein the aqueous ophthalmological composition lacks a cycloplegic,
- wherein when the vial is stored at the temperature from about 2 degrees Celsius to about 8 degrees Celsius for at least 7 months, the stored aqueous ophthalmological composition comprises at least 90% of the aceclidine that the composition comprised at the onset of storing.
A method of treating presbyopia in a human, comprising:
- (a) storing an aqueous ophthalmological composition comprising aceclidine at a concentration from about 0.25% to about 4.0% w/v, mannitol, hydroxypropyl methylcellulose (HPMC), water, polysorbate 80, and water in a vial at a temperature from about 2 degrees Celsius to about 8 degrees Celsius, wherein w/v denotes weight by total volume of the aqueous ophthalmological composition, and wherein the vial comprises a cap and a headspace between the aqueous ophthalmological composition and the cap,
Dependencies are inferred from the claim text.