Topical compositions and methods for making and using same
View Patent ↗The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
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.