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Claims for Patent: 9,161,914

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Claims for Patent: 9,161,914

Title:Topical compositions and methods for making and using same
Abstract: The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
Inventor(s): Hardas; Bhushan (Summerville, NC), Dalton; Donna (High Point, NC)
Assignee: Merz Pharmaceuticals, LLC (Raleigh, NC)
Application Number:14/297,293
Patent Claims: 1. A method of treating a fungal infection in a patient in need thereof, comprising administering to the patient a gel composition consisting essentially of: (i) naftifine or a pharmaceutically acceptable salt thereof, present in an amount of from about 0.5 wt % to about 4 wt %; (ii) a first solvent which is a glycol solvent, present in an amount of from about 10 wt % to about 25 wt %; (iii) a second solvent which is an alkyl alcohol solvent, present in an amount of from about 10 wt % to about 25 wt %; (iv) a non-carbomer rheology modifier selected from a hydroxy cellulose, present in an amount of from about 0.75 wt % to about 2.25 wt %; (v) a polysorbate solubilizing agent present in an amount of from about 3 wt % to about 8 wt %; (vi) a pH adjuster selected from an amine base; and optionally one or more of: water, a preservative, a chelating agent, a coloring agent, and a fragrance, wherein the gel composition has a pH of about 4.5 to about 6.0.

2. The method according to claim 1, wherein the fungal infection is a superficial fungal infection of the skin.

3. The method according to claim 2, wherein the superficial fungal infection of the skin is selected from Tinea cruris, Tinea corporis, interdigital Tinea pedis, moccasin-type Tinea pedis, Tinea manuum, Tinea versicolor (pityriasis), Tinea nigra, cutaneous candidiasis, Tinea faciei, and white and black piedra.

4. The method according to claim 3, wherein the superficial fungal infection of the skin is selected from interdigital Tinea pedis.

5. The method according to claim 4, wherein the interdigital Tinea pedis is caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or Trichophyton rubrum.

6. The method according to claim 1, wherein the naftifine or a pharmaceutically acceptable salt thereof is present in an amount of from about 1.0 wt % to about 3.0 wt %.

7. The method according to claim 1, wherein the glycol solvent is present in an amount of about 18 wt % to about 22 wt %.

8. The method according to claim 7, wherein the glycol solvent is propylene glycol.

9. The method according to claim 1, wherein the alkyl alcohol is present in an amount of from about 17 wt % to about 22 wt %.

10. The method according to claim 9, wherein the alkyl alcohol is ethanol.

11. The method according to claim 1, wherein the hydroxy cellulose is hydroxyethyl cellulose.

12. The method according to claim 1, wherein the polysorbate solubilizing agent is Polysorbate 20.

13. The method according to claim 1, wherein the polysorbate solubilizing agent is Polysorbate 80.

14. The method according to claim 1, wherein the naftifine, or pharmaceutically acceptable salt thereof, is naftifine hydrochloride.

15. The method according to claim 1, wherein the naftifine, or a pharmaceutically acceptable salt thereof, is present in an amount of about 2.0 wt %, the glycol solvent is present in an amount of about 20 wt %, the alkyl alcohol solvent is present in an amount of about 19 wt %, the non-carbomer rheology modifier is present in an amount of about 1.75 wt %, and the polysorbate solubilizing agent is present in an amount of about 5 wt %.

16. The method according to claim 15, wherein the glycol solvent is propylene glycol.

17. The gel composition of claim 15, wherein the alcohol solvent is ethanol.

18. The gel composition of claim 15, wherein the non-carbomer rheology modifier is hydroxyethyl cellulose.

19. The method according to claim 15, wherein the polysorbate solubilizing agent is Polysorbate 20 or Polysorbate 80.

20. The method according to claim 15, wherein the naftifine or pharmaceutically acceptable salt thereof is naftifine hydrochloride.

21. The method according to claim 1, consisting essentially of 2.0 wt % naftifine hydrochloride, about 20 wt % propylene glycol, about 19 wt % ethanol, about 5 wt % Polysorbate 20, about 1.75 wt % hydroxyethyl cellulose, about 1.0 wt % benzyl alcohol, about 0.17 wt % trolamine, about 0.02 wt % ethylenediaminetetracetic acid or a salt thereof, water, and optionally one or more of a coloring agent and a fragrance.
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