LOW TEMPERATURE DRYING METHODS FOR FORMING DRUG-CONTAINING POLYMERIC COMPOSITIONS

摘要

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.

主权项

1. An implantable medical device made by a method comprising:
providing an implantable medical device; forming a drug-containing polymeric composition comprising a biocompatible polymeric matrix with one or more therapeutic agents, wherein said polymeric matrix further comprises one or more organic or aqueous solvents, the polymeric matrix comprising at least two polymers; oven drying the drug-containing polymeric composition for first period of time so as to reduce solvent content in the polymeric matrix; 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 at least six hours to reduce porosity in the drug-containing polymeric composition during the supercritical carbon dioxide process; and coating at least a portion of the implantable drug device with the drug-containing composition.