Iontophoretic microneedle device

1. A method for the preparation of a polymeric microneedle array for delivery of macromolecular compounds through the skin having a plurality of micro-scaled solid dissolvable microneedles, each of the microneedles being entirely made of a dried polymer composition which is dissolvable upon contact with the skin, the polymer composition comprising:

15 to 40 wt. % of a water soluble polymer as a binder,

less than 2 wt. % of a humectant/softener, and

less than 2 wt. % of a surfactant;

and

1 to 15 wt. % of the macromolecular compound encapsulated in the polymer, wherein the wt. % are given with respect to the liquid polymer composition before drying, said method comprising the steps of:

dissolving

15 to 40 wt. % of a water soluble polymer as a binder,

less than 2 wt. % of a humectant/softener, and

less than 2 wt. % of a surfactant, and

1 to 15 wt. % of a macromolecular compound

in water, to prepare a liquid polymer composition; wherein the wt. % are given with respect to the liquid polymer composition before drying;

molding the liquid polymer composition in flexible molds having the negative form of the microarray to be produced;

drying the polymer composition within the mold; and

removing the dried polymeric having formed solid dissolvable microneedles from the mold;

wherein the humectant and softener is present in the liquid polymer composition before drying in an amount of 0.5 to 1.5 wt. %.

2. The method of claim 1 , wherein the water soluble polymer is polyvinylpyrrolidone (PVP).

3. The method of claim 2 , wherein the water soluble polymer is a medium viscosity PVP having an average molecular weight (Mw) of about 40,000.

4. The method of claim 1 , wherein the humectant and softener is glycerol.

5. The method of claim 1 , wherein the surfactant is polysorbate 80.

6. The method of claim 1 , wherein the macromolecular compound is hydrophilic.

7. The method of claim 1 , wherein the macromolecular compound is sumatriptan or sumatriptan succinate.

8. The method of claim 1 , wherein the water soluble polymer is present in the liquid polymer composition before drying in an amount of 20 to 30 wt. %.

9. The method of claim 1 , wherein the surfactant is present in the liquid polymer composition before drying in an amount of 0.05 to 1.0 wt. %.

10. The method of claim 1 , wherein the macromolecular compound is present in the liquid polymer composition before drying in an amount of 5 to 10 wt. %.

11. The method of claim 1 , wherein the water soluble polymer is a medium viscosity PVP having an average molecular weight (Mw) of about 40,000.

12. The method of claim 1 , wherein the micro-scaled solid dissolvable microneedles have a height of about 50 to 900 μm and a surface density of about 2,000 needles/cm 2 or less.

13. An active transdermal patch device for delivery of macromolecular compounds through the skin, comprising:

a power supply with controllable current source,

a skin cathode electrically connected to the power supply, and

a skin anode electrically connected to the power supply, the anode comprising a microneedle array having a plurality of micro-scaled solid dissolvable microneedles, each of the microneedles being entirely made of a dried polymer composition which is dissolvable upon contact with the skin, the microneedle arrays being obtained by the method of claim 1 .

14. A polymeric for delivery of macromolecular compounds through the skin having a plurality of micro-scaled solid dissolvable microneedles, the microneedles consisting of a dried polymer composition which a water soluble consists of polymer, a humectant softener, a surfactant, and the encapsulated macromolecular compound, and wherein the polymeric is obtained by the method of claim 1 .

15. A polymeric for delivery of macromolecular compounds through the skin having a plurality of micro-scaled solid dissolvable microneedles, each of the microneedles being entirely made of a dried polymer composition which is dissolvable upon contact with the skin, the polymeric microneedle array being obtained by the method of claim 1 .