Patent Application
20140257204
The present invention relates to applicators and, more particularly, to an apparatus for reconstituting and dispensing lyophilized and/or vialed drugs for topical application.
Drugs manufactured for systemic use (intravenous or injection) can be used topically on the skin. There is no simple means of removing these drugs from their containers (vials) and applying them to the skin. Current methods to use systemic drugs for topical application require multiple steps and devices by an individual or reliance on a compounding pharmacist.
When an individual attempts to create a topically applied drug, there are often variations in the individual methods of removing drug from the vial, the methods of mixing the contents, the vessels used and the application methods. These variations can contribute to poor quality control of topical preparations and drug efficacy.
Some conventional devices and methods for preparing topical applications for lyophilized and/or vialed drugs are cumbersome and can expose the drug to contamination risks. Moreover, some conventional devices and methods can pose a potential unwanted drug exposure risk to individuals.
As can be seen, there is a need for an apparatus and methods for reconstituting and dispensing lyophilized and/or vialed drugs for topical application.
In one aspect of the present invention, an apparatus for topical administration of a therapeutic agent comprises a syringe; a plunger fitting into a first end of the syringe and pushing contents of the syringe out a second end of the syringe; a vial extraction adapter fitting on the second end of the syringe; a needle end of the vial extraction adapter fitting into a vial; an applicator adapter fluidly connecting to the first end of the syringe when the plunger is removed therefrom; and an applicator end of the applicator adapter operable to deliver the therapeutic agent topically to a user.
In another aspect of the present invention, an apparatus for topical administration of a therapeutic agent comprises a syringe; a plunger fitting into a first end of the syringe and pushing contents of the syringe out a second end of the syringe; a vial extraction adapter fitting on the second end of the syringe; a needle end of the vial extraction adapter fitting into a vial; an applicator adapter fluidly connecting to the first end of the syringe when the plunger is removed therefrom; an applicator end of the applicator adapter operable to deliver the therapeutic agent topically to a user; a syringe cap removably fitting on the second end of the syringe to prevent fluid from escaping therefrom; and an applicator end cap removably fitting on the applicator adapter to cover the applicator end.
In a further aspect of the present invention, a method for topically applying a therapeutic agent comprises disposing a reconstituting solution in a syringe, the syringe having a plunger disposed in a first end thereof; fitting a vial extraction adapter to a second end of the syringe; attaching a vial to the vial extraction adapter; depressing the plunger to introduce the reconstituting solution into the vial; withdrawing the plunger to withdraw reconstituted therapeutic agent solution from the vial; removing the vial extraction adapter from the syringe; placing a syringe cap on the syringe to retain the reconstituted therapeutic agent in the syringe; removing the plunger from the syringe; placing an applicator adapter on the first end of the syringe; and delivering the reconstituted therapeutic agent in the syringe through the applicator adapter to an applicator end thereof.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims.
The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention, since the scope of the invention is best defined by the appended claims.
Broadly, an embodiment of the present invention provides an apparatus and methods for reconstituting and/or removing lyophilized and/or vialed drugs for topical application. The apparatus includes a syringe having a removable plunger. A vial extraction adapter can interconnect the syringe and a vial, allowing a user to transfer a reconstituting solution from the syringe to the vial. After appropriate mixing, the user can then easily remove the reconstituted drug solution from the vial into the syringe. A cap can then be placed on that end of the syringe and the plunger of the syringe can be removed. An application adapter can be placed over the opening from which the plunger was removed. A cap of the application adapter can cover an applicator end that can be used to apply the liquid drug substance from the syringe. The cap of the application adapter can be replaced and any unused drug produced can be stored until needed again.
The apparatus and methods of the present invention simplified and standardizes the method for reconstituting and dispensing lyophilized drugs from vials. The apparatus and methods of the present invention further reduce risks of contamination while enhancing ease of application.
Referring to
The kit 10 can include a vial extraction adapter 18 that interconnects the syringe 12 with a vial 21. A needle end 19 of the vial extraction adapter 18 can puncture a membrane 21 of the vial 20 to access the contents within the vial 20.
The kit 10 can include an applicator adapter 15. A base 16 of the applicator adapter 15 can attach to the first end of the syringe 12 when the plunger 13 is removed. The applicator adapter 15 can allow liquid in the syringe 12 to flow to an applicator end 26 (see
Referring now to
The vial extraction adapter 18 can be placed on the syringe 12 and a vial 20 can be attached to the needle end 19 of the vial extraction adapter 18, as shown in
The plunger 13 can be depressed to introduce the reconstituting solution 23 into the vial, as shown in
As shown in
The plunger 13 can be removed, as shown in
The kit 10 of the present invention can be used for topical delivery of various drug products. These drug products, disposed in the vial 20, can be liquid drug products, solid (lyophilized) drug products, or solutions of drug products. The reconstituting solution 23 can be various compositions. Typically, the reconstituting solution 23 can be formed to allow the drug product in the vial 20 to dissolve therein. In some embodiments, the reconstituting solution 23 can include ingredients designed to assisted in the transdermal delivery of drug product.
It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.
