Topical cyclosporine-containing formulations and uses thereof
AssigneeSun Pharmaceutical Industries Limited
InventorsSidney L. Weiss, Ashim K. Mitra, Eugene J. McNally
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Abstract
Provided herein are formulations for topical ophthalmic formulations containing 0.087-0.093 wt % of cyclosporine, and methods of making and using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also included herein are methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.
Claims16
A method of treating an inflammatory ocular disease in a subject, comprising administering to the subject an ophthalmic aqueous topical formulation consisting of:
- 0.087-0.093 wt % cyclosporine;
- about 1.0 wt % hydrogenated 40 polyoxyl castor oil;
- about 0.05 wt % octoxynol-40;
- about 0.3 wt % povidone;
- about 0.05 wt % sodium chloride;
- phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid;
- and
- water.
A method of increasing tear production in a subject in need thereof, comprising administering to the subject an ophthalmic aqueous topical formulation consisting of:
- 0.087-0.093 wt % cyclosporine;
- about 1.0 wt % hydrogenated 40 polyoxyl castor oil;
- about 0.05 wt % octoxynol-40;
- about 0.3 wt % povidone;
- about 0.05 wt % sodium chloride;
- phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid;
- and
- water.
A method of treating keratoconjunctivitis sicca in a subject, comprising administering twice daily to the subject an ophthalmic aqueous topical formulation consisting of:
- 0.087-0.093 wt % cyclosporine;
- about 1.0 wt % hydrogenated 40 polyoxyl castor oil;
- about 0.05 wt % octoxynol-40;
- about 0.3 wt % povidone;
- about 0.05 wt % sodium chloride;
- phosphate buffer, adjusted to a pH of about 5 to about 8 with sodium hydroxide and/or hydrochloric acid;
- and
- water.
Dependencies are inferred from the claim text.