PUMP SYSTEMS AND METHODS FOR STORING AND DISPENSING A PLURALITY OF PRECISELY MEASURED UNIT-DOSES OF IMIQUIMOD CREAM

摘要

The present invention is directed to airless storage and dispensing systems that include a pump or dispensing package pre-filled with a topical semi-solid imiquimod pharmaceutical formulation (“pump systems”) and methods for storing and dispensing from the pump systems a plurality of precisely measured and uniform unit doses of a topical semi-solid imiquimod pharmaceutical formulation, and more particularly to pump systems, pre-filled with a topical imiquimod pharmaceutical cream and methods for delivering multiple precisely measured unit doses of a topical imiquimod pharmaceutical cream, and methods for using a controlled delivery pump system to store and dispense a plurality of consistent and precisely measured unit doses of a topical imiquimod pharmaceutical cream for use in topically treating a dermal and mucosal-associated condition, such as, external genital warts and/or perianal warts (EGWs), actinic keratosis or actinic keratoses (AK or AKs) and superficial basal cell carcinoma (sBCC).

主权项

1. A system for treating a subject diagnosed with a dermal and/or mucosal-associated condition, said system comprising:
a dispensing device that includes:
a lower subassembly that has a tubular body portion that defines an elongated interior fluid storage chamber into which a take-up piston element is slidably disposed; andan upper subassembly mounted upon the lower subassembly and including a dispensing head and an airless pumping mechanism, the dispensing head having an internal fluid passage formed therein which terminates in a self-closing outlet, the dispensing head also including and a finger-operated actuator which is operatively associated with the airless pumping mechanism; and an imiquimod cream formulation disposed at least partially within the fluid storage chamber defined in the tubular body portion of the lower subassembly of the dispensing package, and wherein operation of the finger-operated actuator causes the airless pumping mechanism to withdraw a portion of the imiquimod cream formulation from within the interior chamber and to dispense the imiquimod cream formulation into the internal fluid passage formed in the dispensing head wherein the pressure of dispensed cream causes the self-closing outlet to open thereby discharging a predefined unit dose amount of imiquimod cream from the dispensing package.