# US 11,077,102 B2 · Multidose package, course and method of treatment for delivering predetermined multiple doses of a pharmaceutical > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,102 B2 - Document ID: US11077102B2 - Status: Granted - Kind: B2 - Application number: 16/280,600 - Filed: 2019-02-20 - Published: 2019-11-21 - Granted: 2021-08-03 - Earliest claimed: 2009-04-01 - Assignees: Bausch Health Ireland Limited - Applicants: Bausch Health Ireland Limited - Inventors: Mark J. Hutchings; Christiaan M. Niekerk - Web page: https://patentgrep.com/patent/US11077102B2 ## CPC - A61K 31/4745: condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines (yohimbine derivatives, vinblastine A61K31/475; ergoline derivatives A61K31/48) - A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} - A61K 31/437: the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline - A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives - A61P 17/00: Drugs for dermatological disorders - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - B65B 3/04: Methods of, or means for, filling the material into the containers or receptacles - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) ## Abstract A multidose package containing an imiquimod formulation suitable for treating topical conditions includes: a) a dispensing aperture for dispensing the formulation from the package; b) a reservoir containing sufficient formulation to provide two or more doses; c) a metered dosage element for measuring a predetermined dose of the formulation, the element including an inlet from the reservoir and an outlet to the dispensing aperture; and d) an actuating element operating the dosage element so the predetermined dose is delivered to the dispensing aperture; wherein the dose is dispensed without microbial or other contamination or degradation of the formulation in reservoir. A corresponding course of treatment for various maladies includes providing a multidose package containing an imiquimod formulation suitable for the treatment. A corresponding method of treatment of diseases with multiple doses of an imiquimod formulation includes multiple doses provided by a multidose package. ## Claims ### Claim 1 A method of treatment of actinic keratosis, superficial basal cell carcinoma or 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) a dispensing aperture for dispensing the formulation from the package; b) a reservoir containing a sufficient amount of said formulation to provide two or more doses; 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 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. ### Claim 2 (depends on 1) The method of treatment of claim 1, wherein the inlet comprises a one way valve to the reservoir. ### Claim 3 (depends on 2) The method of treatment of claim 2, wherein the one way valve isolates the reservoir contents and prevents any back-flow of air and/or formulation into the reservoir once a volume of formulation enters the metered dosage means. ### Claim 4 (depends on 1) The method of treatment of claim 1, wherein an airless pump is associated with said metered dosage means. ### Claim 5 (depends on 4) The method of treatment of claim 4, wherein the airless pump has a body made of HD polyethylene, a piston made of LD polyethylene, an outlet port or stem of polypropylene and an inlet port or dip tube of polypropylene. ### Claim 6 (depends on 1) The method of treatment of claim 1, wherein the imiquimod is present in the formulation in an amount of 0.1 to 10% w/w. ### Claim 7 (depends on 1) The method of treatment of claim 1, wherein the imiquimod is present in the formulation in an amount of 5% w/w. ### Claim 8 (depends on 1) The method of treatment of claim 1, wherein the method of treatment is for actinic keratosis. ### Claim 9 (depends on 8) The method of treatment of claim 8, wherein the package has a volume of formulation in the reservoir suitable for treatment for 2 weeks, 3 weeks or 6 weeks. ### Claim 10 (depends on 1) The method of treatment of claim 1, wherein the method of treatment is for basal cell carcinoma. ### Claim 11 (depends on 10) The method of treatment of claim 10, wherein the package has a volume of formulation in the reservoir suitable for treatment for 2 weeks, 4 weeks, 8 weeks or 16 weeks. ### Claim 12 (depends on 1) The method of treatment of claim 1, wherein the method of treatment is for genital warts. ### Claim 13 (depends on 12) The method of treatment of claim 12, wherein the package has a volume of formulation in the reservoir suitable for treatment for 2 weeks, 4 weeks, 8 weeks or 16 weeks. ### Claim 14 (depends on 6) The method of treatment of claim 6, wherein the package has a volume of formulation in the reservoir suitable for 6, 12 or 24 doses. ### Claim 15 (depends on 6) The method of treatment of claim 6, wherein the predetermined dose is about 80 mg of formulation. ### Claim 16 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. ### Claim 17 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.