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.
[EN] STABLE BROMFENAC OPHTHALMIC SOLUTION<br/>[FR] SOLUTION OPHTALMIQUE STABLE DE BROMFÉNAC
申请人:SENTISS PHARMA PRIVATE LTD
公开号:WO2015087267A2
公开(公告)日:2015-06-18
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.