Patent ID: 8637111

Claim:
A method, comprising the steps of: a. providing a device body; b. disposing a reservoir layer composition comprising a bioactive agent, a hydrophilic polymer that, if the bioactive agent is also hydrophilic, is more hydrophilic than the bioactive agent, and a first polar solvent over the device body; c. removing the solvent from the composition to form a reservoir layer; d. repeating steps b. and c. until a desired reservoir layer thickness and bioactive agent concentration is achieved; e. determining a release rate curve for the bioactive agent from the reservoir layer; and f. selecting a desired release rate, the desired release rate being either slower or faster than the release rate determined in step e.; and on at least one subsequent occasion, executing steps a. to e. subject to one or more modifications based on the selection of step f., and also executing step f. after the subsequent execution of steps a. to c. if steps a. to e. are to be executed on another subsequent occasion; wherein if the desired release rate selected in step f. is slower, at least one of the one or more modifications is selected from the group consisting of: substituting a second polar solvent for the first polar solvent, the second polar solvent being more polar than the first polar solvent; lowering the temperature of the environment during the solvent removal; if the solvent was removed in an open system during the previous execution of steps a. to e., removing the solvent in a closed system; and if the solvent was removed in a closed system during the previous execution of steps a. to e., increasing the initial partial pressure of the solvent in the system, the solvent being the first polar if no substitution has been made, and the solvent being the second polar solvent if substitution is being made; wherein if the desired release rate selected in step f. is faster, at least one of the one or more modifications is selected from the group consisting of: substituting a second polar solvent for the first polar solvent, the second polar solvent being less polar than the first polar solvent; increasing the temperature of the environment during the solvent removal; if the solvent was removed in a closed system during the previous execution of steps a. to e., decreasing the initial partial pressure of the solvent in the system, the solvent being the first polar solvent if no substitution is being made, and the solvent being the second polar solvent if substitution is being made; and if the solvent was removed in a closed system during the previous execution of steps a. to e., removing the solvent in an open system; and wherein in each subsequent execution of steps a. to e., the polar solvent used, whether the polar solvent has been substituted or not, will be considered the “first polar solvent” with respect to evaluating modifications for an additional execution of steps a. to e.