Applicator system for applying a viscous liquid to the human skin

Patent metadata

Field	Value
Publication number	US-9827407-B2
Application number	US-201214128785-A
Country	US
Kind code	B2
Filing date	Jun 20, 2012
Priority date	Jun 27, 2011
Publication date	Nov 28, 2017
Grant date	Nov 28, 2017

Abstract

The application relates to an applicator system ( 1 ) for applying a viscous liquid, in particular a transdermal pharmaceutical formulation, to the human skin comprising a metering dispenser ( 2 ) in turn comprising a container holding the viscous liquid and a pump ( 5 ) for metering the liquid and an applicator ( 3 ) detachably connected to the dispenser ( 2 ) and comprising an application surface ( 6 ) for receiving a metered amount of the liquid from the dispenser ( 2 ). The application surface ( 6 ) is convex.

First claim

The invention claimed is:

1. An applicator system for applying a transdermal pharmaceutical formulation, comprising:
a metering dispenser comprising a container for holding a supply of the formulation and a pump for dispensing a metered amount of the formulation, wherein the formulation is in a form of a viscous liquid;
an applicator detachably connected to and enveloping the dispenser, wherein the applicator comprises a convex application surface for receiving a metered amount of the formulation from the dispenser, and the application surface is devoid of any aperture and porous region for metering the liquid to the application surface from the supply within; and
a hygiene cap configured to cover the application surface.

2. The applicator system according to claim 1 , wherein the application surface is rigid.

3. The applicator system according to claim 2 , wherein the material forming the application surface has a Young's modulus of at least 1.5 GPa.

4. The applicator system according to claim 2 , wherein the application surface is smooth.

5. The applicator system according to claim 1 , wherein the dispenser has a metering accuracy of +/−15%, the dispenser dispenses the formulation in a range from 0.5 ml to 2.5 ml for each actuation, or both.

6. The applicator system according to claim 1 , wherein the applicator doubles as a cap for the metering dispenser.

7. The applicator system according to claim 6 , wherein the applicator comprises a sleeve to receive and secure the metering dispenser.

8. The applicator system according to claim 6 , wherein the applicator has a total length of at least 6.5 centimeters, the applicator has at least 50% of the total length as a grip, or both.

9. The applicator system according to claim 1 , wherein the application surface comprises a symbol, wherein the symbol marks an optimum location for placing the metered amount of the formulation onto the application surface.

10. The applicator system according to claim 1 , wherein the viscous liquid has a viscosity of at least 3000 centipoise at 25 C.

11. The applicator system according to claim 1 , wherein the formulation comprises at least one active agent and a solvent system present in an amount sufficient to solubilize the at least one active agent.

12. The applicator system according to claim 11 , wherein the active agent is an androgen steroid hormone.

13. The applicator system according to claim 12 , wherein the androgen steroid hormone is chosen from testosterone and a testosterone derivative.

14. The applicator system according to claim 13 , wherein the testosterone is chosen from (8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17 dodecahydrocyclopentaphenanthren-3-one, testosterone enanthate, testosterone propionate, testosterone cypionate, testosterone phenylacetate, testosterone acetate, testosterone isobutyrate, testosterone buciclate, testosterone heptanoate, testosterone decanoate, testosterone undecanoate, testosterone caprate, testosterone isocaprate, 4-dihydrotestosterone, and combinations thereof.

15. The applicator system according to claim 13 , wherein the testosterone derivative is chosen from methyl testosterone, testolactone, oxymetholone, and fluoxymesterone.

16. The applicator system according to claim 11 , wherein the formulation comprises a C 2 to C 4 alkanol in an amount from about 5-50% wt, a polyalcohol in an amount from about 1-30% wt, a permeation enhancer in an amount from about 0.2-25% wt, a gelling agent in an amount from about 0.05-4% wt, a neutralizing agent in an amount from about 0.05-1% wt, and a chelating agent in an amount from about 0.001-5.0% wt.

17. The applicator system according to claim 16 , wherein the C 2 to C 4 alkanol is ethanol and the polyalcohol is propylene glycol.

18. The applicator system according to claim 16 , wherein the formulation further comprises 1%-2% wt testosterone, and a monoalkyl ether of diethylene glycol, wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

19. The applicator system according to claim 18 , wherein the monoalkyl ether of diethylene glycol is diethylene glycol monoethyl ether.

20. The applicator system according to claim 18 , wherein the formulation comprises 2% wt testosterone.

21. The applicator system according to claim 11 , wherein the formulation comprises 1% wt-2% wt testosterone, 44.0% wt ethanol, 20.0% wt propylene glycol, and 5.0% wt diethylene glycol monoethyl ether, wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

22. The applicator system according to claim 11 , wherein the formulation comprises 1 wt-2% wt testosterone, 44.0% wt ethanol, 20.0% wt propylene glycol, 5.0% wt diethylene glycol monoethyl ether, 1.20% wt carbomer, 0.35% wt triethanolamine, 0.06% wt edetate disodium and water (q.s.), wherein the formulation is substantially free of long-chain fatty alcohols, long-chain fatty acids, and long-chain fatty esters.

23. The applicator system according to claim 22 , wherein the formulation consists of 1% wt-2% wt testosterone, 44.0% wt ethanol, 20.0% wt propylene glycol, 5.0% wt diethylene glycol monoethyl ether, 1.20% wt carbomer, 0.35% wt triethanolamine, 0.06% wt edetate disodium and water (q.s.).

24. A kit comprising: (A) the applicator system according to claim 1 , and (B) instructions for use thereof.

25. The kit according to claim 24 , wherein the applicator system dispenses 1.25 ml of the formulation for each actuation of the metered dispenser, and wherein the dispensed formulation consists of 2% wt testosterone, 44.0% wt ethanol, 20.0% wt propylene glycol, 5.0% wt diethylene glycol monoethyl ether, 1.20% wt carbomer, 0.35% wt triethanolamine, 0.06% wt edetate disodium and water (q.s.).

Assignees

• Carrara Dario
• Burke John Edward
• Robinson David George
• Fernall Robert Peter
• Ferring Bv

Inventors

• Carrara Dario
• Burke John Edward
• Robinson David George
• Fernall Robert Peter

Classifications

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A45D34/04

  Appliances specially adapted for applying liquid, e.g. using roller or ball · CPC title

• B65D47/42

  with pads or like contents-applying means · CPC title

• A61M35/003 Primary

  Portable hand-held applicators having means for dispensing or spreading integral media (hand-held massage devices with liquid delivery A61H7/003) · CPC title

• B65D83/00

  Containers or packages with special means for dispensing contents (dispensing means incorporated in closures B65D47/00) · CPC title