Low temperature drying methods for forming drug-containing polymeric compositions
View Patent ↗The present invention relates to a process for reducing solvent contents in drug-containing polymeric compositions. Specifically, the solvent contents in the drug-containing polymeric compositions are first reduced by one or more conventional drying methods, to a range from about 0.5 wt % to about 10 wt % of the total weight of the polymeric composition. Subsequently, the drug-containing polymeric compositions are further treated by one or more low temperature (i.e., having processing temperatures of less than 60° C.) drying methods for further reduction of the solvent content to less than 10,000 ppm.
1. A method for fabricating an implantable medical device comprising:
forming a drug-containing polymeric composition comprising a biocompatible polymeric matrix with one or more therapeutic agents and one or more radiopaque agents incorporated into the implantable medical device, wherein said polymeric matrix further comprises one or more organic solvents, the polymeric matrix comprising at least two polymers;
oven drying the drug-containing polymeric composition for a first period of time at a processing temperature of not higher than 60° C. so as to reduce solvent content in the polymeric matrix to an amount ranging from about 0.5 wt. % to about 10 wt. % of the total weight of the polymeric matrix; and
subsequently removing additional solvents from the drug-containing polymeric composition after oven drying the composition utilizing a supercritical carbon dioxide process to reduce solvent content in the polymeric matrix to an amount less than about 10,000 ppm of the polymeric matrix, wherein the first period of time is selected to reduce porosity in the drug-containing polymeric composition during the supercritical carbon dioxide process.