PHOSPHOLIPID DEPOT

摘要

The present invention provides a clear depot comprising at least one hydrophilic water-soluble pharmaceutically active agent selected from the group consisting of vancomycin, gentamicin, a pharmaceutically acceptable salt thereof and a mixture thereof, water, a phospholipid, an oil, optionally a pH adjusting agent, and a viscosity modifying agent selected from the group consisting of ethanol, isopropanol, and a mixture thereof, wherein the water present in the depot is no more than about 4 wt % relative to the total weight of the depot and the depot has a pH of between about 3 and about 6, method of making and administering same.

主权项

1. A method for making a depot comprising:
(a) forming an oil-in-water emulsion including a phospholipid, an oil, at least one hydrophilic water-soluble pharmaceutically active agent selected from the group consisting of vancomycin, gentamicin, a pharmaceutically acceptable salt thereof and a mixture thereof and water; (b) converting the emulsion to a monophasic solution having a pH of between about 3 to about 6; (c) lyophilizing the monophasic solution to obtain a dry paste, (d) adding a viscosity modifying agent to the dry paste in an amount sufficient to obtain a viscosity modified solution, (e) removing at least some of the viscosity modifying agent to obtain a depot, and (f) sterilizing the depot, wherein the water present in the depot is no more than about 4 wt % relative to the total weight of the depot.