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Claims for Patent: 5,514,698

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Claims for Patent: 5,514,698

Title: Antifungal vaginal cream composition
Abstract:A long-lasting antifungal vaginal cream composition having stable viscosity at human body temperature is disclosed.
Inventor(s): Ahmad; Nawaz (Monmouth Jct., NJ), Brummer; Barbara (Upper Montclair, NJ), Dalal; Nandita M. (East Brunswick, NJ), Toddywala; Rohinton (North Brunswick, NJ)
Assignee: Ortho Pharmaceutical Corporation (Raritan, NJ)
Application Number:08/216,215
Patent Claims: 1. A long-lasting viscous antifungal vaginal cream composition comprising about 0.4 to 10.0% of an imidazole antifungal agent; about 1.0% to 5.0% of a fatty acid ester; about 1.0% to 25.0% of aliphatic alcohols; about 2.0% to 5.0% of a surfactant; about 0.02% to 0.20% of an antioxidant; a sufficient amount of inorganic base to adjust the pH range to a value of about 3.0 to 7.0 and water, said composition maintaining its viscosity when the temperature of the cream is raised to 37.degree. C.

2. The composition according to claim 1 wherein the imidazole is selected from the group consisting of miconazole, econazole, terconazole, saperconazole, itraconazole, ketoconazole, and clotrimazole.

3. The composition according to claim 1 wherein the ester is selected from the group consisting of isopropyl stearate, isopropyl myristate, isopropyl palmitate, and isopropyl laurate.

4. The composition according to claim 1 wherein the aliphatic alcohols are selected from the group consisting of cetyl alcohol, stearyl alcohol and propylene glycol.

5. The composition according to claim 1 wherein the surfactant is polysorbate 60 or polysorbate 80.

6. The composition according to claim 5 wherein the surfactant has an HLB value of about 15.

7. The composition according to claim 1 wherein the antioxidant is butylated hydroxyanisole.

8. The composition according to claim 1 wherein the inorganic base is sodium hydroxide.

9. The composition according to claim 1 wherein the inorganic base is potassium hydroxide.

10. A long-lasting viscous antifungal vaginal cream composition according to claim 1 wherein said cream has a viscosity of at least about 3.1 Eta (Pas) at 37.degree. C. after at least eight minutes.

11. A long-lasting viscous antifungal vaginal cream composition according to claim 1 wherein said cream has a viscosity which decreases by no more than about 10 percent at 37.degree. C. after at least eight minutes.

12. A method for making a long-lasting viscous antifungal vaginal cream composition comprising the following steps:

(a) mixing an oil phase comprising an aliphatic alcohol, an ester and a surfactant;

(b) separately mixing an aqueous phase comprising water and a humectant;

(c) separately, mixing surfactant, water and an antifungal agent and creating a slurry;

(d) separately mixing an alkaline buffer compound and water;

(e) adding said aqueous phase to said oil phase, mixing and cooling the resulting mixture;

(f) after step (e), adding said slurry to the resulting mixture; and

(g) adding the alkaline buffer compound and water mixture to adjust the pH of the resulting mixture.

13. A method according to claim 12 wherein said antifungal agent is selected from the group consisting of miconazole, econazole, terconazole, sperconazole, itraconazole, ketoconazole, and clotrimazole.

14. A method according to claim 12 wherein said ester is selected from the group consisting of isopropyl stearate, isopropyl myristate, isopropyl palmitate, and isopropyl laurate.

15. A method according to claim 12, wherein said aliphatic alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol and propylene glycol and mixtures thereof.

16. A method according to claim 12 wherein said surfactant is polysorbate 60 or polysorbate 80.

17. A method according to claim 16 wherein said surfactant has an HLB value of about 15.

18. A long-lasting viscous antifungal vaginal cream composition made in accordance with the method of claim 12.

19. A long-lasting viscous antifungal vaginal cream composition comprising about 0.4 to 10.0% of an imidazole antifungal agent; about 1.0% to 5.0% of a fatty acid ester; about 1.0% to 25.0% of aliphatic alcohols; about 2.0% to 5.0% of a surfactant; about 0.02% to 0.20% of an antioxidant; a sufficient amount of inorganic base to adjust the pH range to a value of about 3.0 to 7.0 and water, said surfactant having an HLB which is close to the HLB value of the oil phase of the composition.
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