Abstract: The invention concerns topical ophthalmic preparations in the form of eye-drops in aqueous solution, containing azithromycin (or a pharmacologically acceptable salt thereof) as active ingredient, wherein the azithromycin is solubilized and stabilized by means of ?-cyclodextrins, and in particular by means of the ?-cyclodextrin called sulfobutyl ether ?-cyclodextrin (SBE-?-CD). The proposed preparations have a remarkably high stability, both physical and chemical, which enables its storage at room temperature for the envisaged period of validity for a commercial pharmaceutical product.
Type:
Grant
Filed:
May 6, 2014
Date of Patent:
July 9, 2019
Assignee:
MEDIVIS S.R.L.
Inventors:
Danilo Aleo, Maria Grazia Antonietta Saita, Barbara Melilli, Sergio Mangiafico, Melina Cro
Abstract: The invention concerns topical ophthalmic preparations in the form of eye-drops in aqueous solution, containing azithromycin (or a pharmacologically acceptable salt thereof) as active ingredient, wherein the azithromycin is solubilized and stabilized by means of ?-cyclodextrins, and in particular by means of the ?-cyclodextrin called sulfobutyl ether ?-cyclodextrin (SBE-?-CD). The proposed preparations have a remarkably high stability, both physical and chemical, which enables its storage at room temperature for the envisaged period of validity for a commercial pharmaceutical product.
Type:
Application
Filed:
May 6, 2014
Publication date:
March 17, 2016
Applicant:
MEDIVIS S.R.L.
Inventors:
Danilo ALEO, Maria Grazia Antonietta SAITA, Barbara MELILLI, Sergio MANGIAFICO, Melina CRO
Abstract: The invention concerns ophthalmic pharmaceutical compositions in microemulsion capable of carrying liposoluble or poorly water-soluble active ingredients, containing an emulsifying agent consisting of d-?-tocopheryl polyethylene glycol 1000 succinate (TPGS), an oily component consisting of medium chain triglycerides (MCT) and an ophthalmologically acceptable aqueous phase. The invention further concerns ophthalmic compositions for use a tear substitute, formulated similarly to the previous compositions but without a pharmaceutically active ingredient and containing, in the aqueous phase, polysaccharide polymers or cellulose derivatives known as components for artificial tears. The described preparations are self-emulsifying systems (SMEDDS) characterized by a high stability and by a particularly low concentration of surfactant, and are suitable for topical ocular administration.