Claims for Patent: 10,166,205

Summary for Patent: 10,166,205

Title:	Topical compositions and methods for making and using same
Abstract:	A gel composition for topical administration that includes: naftifine or a pharmaceutically acceptable salt thereof; a solvent; a non-carbomer rheology modifier; a polysorbate solubilizing agent; and an amine pH adjuster.
Inventor(s):	Hardas; Bhushan (Summerville, NC), Dalton; Donna (High Point, NC)
Assignee:	SEBELA INTERNATIONAL BERMUDA LIMITED (Hamilton, BM)
Application Number:	14/857,232
Patent Claims:	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 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 non-carbomer rheology modifier selected from 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 .mu.g/cm.sup.2/hr.sup.1/2 to about 3134 .mu.g/cm.sup.2/hr.sup.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 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, wherein the pH adjuster is present in an amount of from about 0.14 wt % to about 0.21 wt %. 18. The gel composition of claim 17, wherein the pH adjuster is present in an amount of from about 0.15 wt % to about 0.2 wt %. 19. The gel composition of claim 18, wherein the pH adjuster is present in an amount of from about 0.16 wt % to about 0.19 wt %. 20. 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 %. 21. 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 an alkyl alcohol solvent component, present in an amount of from about 10 wt % to about 50 wt %; (iii) 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 %; (iv) a polysorbate solubilizing agent present in an amount of from about 3 wt % to about 8 wt %; (v) an amine pH adjuster; 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 2263 .mu.g/cm.sup.2/hr.sup.1/2 to about 2393 .mu.g/cm.sup.2/hr.sup.1/2. 22. The gel composition according to claim 21, wherein the non-carbomer rheology modifier is hydroxypropyl cellulose. 23. The gel composition according to claim 21, wherein the alkyl alcohol solvent is present in an amount of from about 20 wt % to about 45 wt %. 24. The gel composition according to claim 23, wherein the alkyl alcohol solvent is present in an amount of from about 40 wt % to about 45 wt %. 25. The gel composition according to claim 24, wherein the alkyl alcohol solvent is present in an amount of from about 44 wt % to about 45 wt %. 26. The gel composition according to claim 21, wherein the alkyl alcohol solvent is ethanol. 27. The gel composition according to claim 21, wherein: the naftifine, or a pharmaceutically acceptable salt thereof, is present in an amount of about 2.0 wt %.