Multidose package, course and method of treatment for delivering predetermined multiple doses of a pharmaceutical

A method for treating external genital warts in a patient in need thereof, said method comprising administering to said patient multiple doses of an imiquimod formulation, wherein said multiple doses are provided by a multidose package, said package comprising:

• a dispensing aperture for dispensing the formulation from the package;
• a reservoir containing a sufficient amount of said formulation to provide the required number of dosages for the course of treatment;
• a metered dosage means for measuring a predetermined dose of said formulation, said means comprising an inlet from said reservoir and an outlet to said dispensing aperture, wherein the metered dosage means is in the form of a positive displacement pump and is operated by an actuator associated with the outlet;
• and an actuating means for operating said dosage means such that the predetermined dose is delivered to said dispensing aperture;
• wherein said dose is dispensed without microbial or other contamination or degradation of the formulation in reservoir and wherein the imiquimod is present in the formulation in an amount of 0.1 to 10% w/w.

A method of providing a multidose package containing an imiquimod formulation suitable for treating a topical condition selected from the group consisting of actinic keratosis, superficial basal cell carcinoma and external genital warts, said package comprising:

• a) a dispensing aperture for dispensing the formulation from the package;
• b) a reservoir for said formulation;
• c) a metered dosage means for measuring a predetermined dose of said formulation, said means comprising an inlet from said reservoir and an outlet to said dispensing aperture, wherein the metered dosage means is in the form of a positive displacement pump and is operated by an actuator associated with the outlet;
• and d) an actuating means for operating said dosage means such that the predetermined dose is delivered to said dispensing aperture;
• wherein said dose is dispensed without microbial or other contamination or degradation of the formulation in reservoir;
• said method comprising filling said reservoir with a sufficient amount of said formulation to provide treatment for 2 weeks, 4 weeks, 8 weeks or 16 weeks.