Claims for Patent: 9,539,241

Summary for Patent: 9,539,241

Title:	Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Abstract:	An apparatus and method for preparing a pharmaceutical for transient application includes a tray having a sealed compartment, a vial of an ophthalmic formulation of mitomycin-C, a diluent carrier containing sterilized water, and a syringe that are all contained together in a single package. The component parts of the apparatus are used together to reconstitute the contents of the vial with the water in the diluent carrier, and then draw the reconstituted drug into the sealed compartment of the tray by a suction force produced by the syringe. In the tray compartment, the reconstituted drug is absorbed in at least one absorbent pad. The absorbent pads may come in multiple shapes and or/sizes. The tray is opened to remove the pad and the absorbed drug from the tray compartment for use of the pad in transient application of the drug.
Inventor(s):	Timm; Edward J. (Webster Groves, MO)
Assignee:	MOBIUS THERAPEUTICS, LLC (St. Louis, MO)
Application Number:	13/445,689
Patent Claims:	1. A method for applying an ophthalmic formulation of mitomycin-C to a body tissue comprising: a) providing a sterile dose of an ophthalmic liquid formulation of mitomycin-C; b) providing a tray with a compartment and at least one sterile absorbent pad in the compartment; c) wherein the at least one sterile, absorbent pad comprises an array of pre-cut absorbent pads or sponges with sizes from 3 to 6 mm, wherein said array comprises at least one rectangle and at least one half-moon and at least one wedge; d) injecting said ophthalmic formulation into the compartment and absorbing the mitomycin-C in the pad; e) removing the pad with the absorbed mitomycin-C from the compartment; f) applying the pad with the absorbed mitomycin-C to the body tissue; and g) removing the pad from the body tissue; wherein said dose and tray are housed in a single kit. 2. The method of claim 1, wherein said kit comprises a sterile liquid and a powder formulation of mitomycin-C, further comprising combining said sterile liquid and said powder formulation to form said liquid formulation of mitomycin C prior to step (a). 3. The method of claim 1, wherein the tray has a cover that is movable between opened and closed positions for providing access to the compartment and the pad in the compartment. 4. The method of claim 1, wherein said tray further comprises a passage through which air is aspirated from said compartment. 5. The method of claim 1, further comprising aspirating air from said tray, passively or via suction. 6. The method of claim 1, further comprising unsealing and opening the compartment to remove the pad with the absorbed mitomycin-C from the compartment. 7. A method for applying a sterile liquid pharmaceutical formulation to a body tissue comprising: a) providing a sterile dose of an ophthalmic liquid formulation of mitomycin-C; b) providing a tray with a compartment and at least one sterile absorbent pad in the compartment; c) wherein the at least one sterile, absorbent pad comprises an array of pre-cut absorbent pads or sponges with sizes from 3 to 6 mm, wherein said array comprises at least one rectangle and at least one half-moon and at least one wedge; d) transferring said liquid pharmaceutical formulation into the compartment and absorbing the pharmaceutical in the pad; e) removing the pad with the absorbed mitomycin-C from the compartment; f) applying the pad with the absorbed mitomycin-C to the body tissue; and g) removing the pad from the body tissue; wherein said dose and tray are housed in a single kit. 8. The method of claim 7, further comprising providing a sterile liquid and a powder pharmaceutical formulation, and combining said sterile liquid and said powder formulation to form said liquid formulation prior to step (a). 9. The method of claim 7, wherein the tray has a cover that is movable between opened and closed positions for providing access to the compartment and the pad in the compartment. 10. The method of claim 7, wherein said tray further comprises a passage through which air is aspirated from said compartment. 11. The method of claim 7, further comprising aspirating air from said tray, passively or via suction. 12. The method of claim 7, further comprising unsealing and opening the compartment to remove the pad with the absorbed pharmaceutical from the compartment. 13. The method of claim 7 wherein said pharmaceutical is selected from fluorouracil and mytomycin-C.