Topical compositions and methods for making and using same

1. A gel composition for topical administration 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 gel composition of 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 %.

3. The gel composition of claim 1 , wherein the glycol solvent is present in an amount of about 18 wt % to about 22 wt %.

4. The gel composition of claim 3 , wherein the glycol solvent is propylene glycol.

5. The gel composition of claim 1 , wherein the alkyl alcohol is present in an amount of from about 17 wt % to about 22 wt %.

6. The gel composition of claim 5 , wherein the alkyl alcohol is ethanol.

7. The gel composition of claim 1 , wherein the hydroxy cellulose is hydroxyethyl cellulose.

8. The gel composition of claim 1 , wherein the polysorbate solubilizing agent is Polysorbate 20.

9. The gel composition of claim 1 , wherein the polysorbate solubilizing agent is Polysorbate 80.

10. The gel composition of claim 1 , wherein the naftifine, or pharmaceutically acceptable salt thereof, is naftifine hydrochloride.

11. The gel composition of 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 %.

12. The gel composition of claim 11 , wherein the glycol solvent is propylene glycol.

13. The gel composition of claim 11 , wherein the alcohol solvent is ethanol.

14. The gel composition of claim 11 , wherein the non-carbomer rheology modifier is hydroxyethyl cellulose.

15. The gel composition of claim 11 , wherein the polysorbate solubilizing agent is Polysorbate 20 or Polysorbate 80.

16. The gel composition of claim 11 , wherein the naftifine or pharmaceutically acceptable salt thereof is naftifine hydrochloride.

17. The gel composition of 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.