Stable bromfenac ophthalmic solution
AssigneeSentiss Pharma Private Limited
InventorsMandar V. Shah, Mukesh Tiwari, Deepak Bahri
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Abstract
The present invention provides a stable, aqueous solution comprising a non-steroidal anti-inflammatory drug (NSAID) such as bromfenac or a pharmacologically acceptable salt or a hydrate thereof and a solubilizer. The present invention provides methods to reduce the level of degradation of bromfenac with the addition of pharmaceutically acceptable solubilizers other than an alkyl aryl polyether alcohol type polymer such as tyloxapol, and/or a polyethylene glycol fatty acid ester such as polyethylene glycol monostearate. Also provided are stabilized compositions, and methods of their manufacture and use, e.g., for the treatment of ocular inflammation and pain after cataract surgery.
Claims30
A stable pharmaceutical composition comprising bromfenac, or a pharmaceutically acceptable salt or hydrate thereof, wherein the composition is a solution;
- and wherein the solution has a pH of from about 6.5 to about 8.
A stable pharmaceutical composition comprising bromfenac or a pharmacologically acceptable salt or hydrate thereof, wherein the composition is a solution, is stable, and comprises at least one of:
- a. an polyoxyethylene sorbitan fatty acid esters such as polysorbate 80 or;
- b. a non-ionic solubilizer such as polyoxyl-15-hydroxystearate;
- and wherein the composition does not comprise any of the following;
- c. an alkyl aryl polyether alcohol type polymer;
- d. a polyethylene glycol fatty acid ester or;
- e. an antioxidant.
A method for stabilizing an aqueous solution of bromfenac or its pharmacologically acceptable salt or a hydrate thereof, comprising combining bromfenac or a pharmacologically acceptable salt or hydrate thereof, water, and a solubilizer, wherein the solubilizer is selected from a group consist of either a polyoxyethylene sorbitan fatty acid esters such as polysorbate 80 or a non-ionic soulbilizer such as polyoxyl-15-hydroxystearate.
A method of treating ocular inflammation or pain in a patient in need thereof, comprising administering to an eye of the patient an effective amount of a stable pharmaceutical aqueous solution comprising bromfenac, or a pharmaceutically acceptable salt or hydrate thereof;
- further comprising a polyoxyethylene sorbitan fatty acid ester and/or a polyoxyl-15-hydroxystearate;
- wherein the solution has a pH of from about 6.5 to about 8;
- and wherein the solution does not comprise any of an alkyl aryl polyether alcohol type polymer, a polyethylene glycol fatty acid ester, and an antioxidant.
Use of a composition for treating ocular inflammation or pain in a patient in need thereof, comprising administering to an eye of the patient an effective amount of a stable pharmaceutical aqueous solution comprising bromfenac, or a pharmaceutically acceptable salt or hydrate thereof;
- further comprising a polyoxyethylene sorbitan fatty acid ester and/or a polyoxyl-15-hydroxystearate;
- wherein the solution has a pH of from about 6.5 to about 8;
- and wherein the solution does not comprise any of an alkyl aryl polyether alcohol type polymer, a polyethylene glycol fatty acid ester, and an antioxidant.
Dependencies are inferred from the claim text.