Multidose package, course and method of treatment for delivering predetermined multiple doses of a pharmaceutical
View Patent ↗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.
1. A multidose package containing an imiquimod formulation suitable for treating topical conditions such as 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 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.
2. The package of claim 1 wherein the inlet comprises a one way valve to the reservoir.
3. The package 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.
4. The package of claim 1 wherein the imiquimod is present in the formulation in an amount of 0.1 to 10% w/w.
5. The package of claim 4 wherein the imiquimod is present in the formulation in an amount of 5% w/w.
6. The package of claim 5 suitable for treatment of actinic keratosis.
7. The package of claim 6 wherein the volume of formulation in the reservoir is suitable for treatment for five consecutive days a week for 2 weeks, 3 weeks or 6 weeks.
8. The package of claim 5 suitable for the treatment of basal cell carcinoma.
9. The package of claim 8 having a volume of formulation in the reservoir suitable for treatment regime three times a week for 2 weeks, 4 weeks, 8 weeks or 16 weeks.
10. The package of claim 5 suitable for the treatment of genital warts.
11. The package of claim 10 having a volume of formulation in the reservoir suitable for treatment three times a week for 2 weeks, 4 weeks, 8 weeks or 16 weeks.
12. The package of claim 5 having a volume of formulation in the reservoir suitable for 6, 12 or 24 doses.
13. The package of claim 5 wherein the predetermined dose of formulation is about 80 mg.