Topical compositions and methods for making and using same
The present invention relates to improved topical gel compositions comprising an active agent, and uses thereof.
1. A gel composition for topical administration comprising:
(i) naftifine or a pharmaceutically acceptable salt thereof, present in an amount of from about 0.5 wt % to about 4 wt %;
(ii) a solvent comprising a glycol solvent component and an alkyl alcohol solvent component, present in an amount of from about 10 wt % to about 50 wt %;
(iii) a hydroxy cellulose, present in an amount of from about 0.75 wt % to about 2.25 wt %;
(iv) a polysorbate solubilizing agent present in an amount of from about 3 wt % to about 8 wt %;
(v) an amine pH adjuster in an amount of from about 0.12 wt % to about 0.23 wt %; and
one or more of: water, a preservative, a chelating agent, a coloring agent, and a fragrance, wherein the gel composition exhibits an in vitro release rate under the SUPAC-SS guidance of from about 2700 μg/cm 2 /hr 1/2 to about 3134 μg/cm 2 /hr 1/2 .
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 hydroxy cellulose 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 according to claim 1 , wherein:
the naftifine, or a pharmaceutically acceptable salt thereof, is present in an amount of about 2.0 wt %.