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Claims for Patent: 7,838,558

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Claims for Patent: 7,838,558

Title:Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Abstract:Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Czernielewski; Janusz (Biot, FR)
Assignee: Galderma Research & Development S.N.C. (Valbonne, FR)
Application Number:12/103,182
Patent Claims: 1. A topically applicable pharmaceutical composition comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or pharmaceutically acceptable salt thereof relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, with the proviso that when the composition is formulated as a topically applicable gel, it is an aqueous gel comprising at least one carbomer gelling agent and wherein the sole anti-acne ingredient is adapalene.

2. The topically applicable pharmaceutical composition as defined by claim 1, comprising a topically applicable aqueous gel, or a cream or a lotion.

3. The topically applicable pharmaceutical composition as defined by claim 1, comprising an ointment, cream, milk, pomade, powder, impregnated pad, solution, aqueous gel, spray, lotion, patch, hydrogel, or suspension of microspheres or nanospheres of lipid or polymeric vesicles.

4. The topically applicable pharmaceutical composition as defined by claim 1, consisting essentially of an aqueous gel of: Adapalene, Carbomer 940, Disodium edetate, Methyl paraben, Poloxamer 124, Propylene glycol, Sodium hydroxide, and Purified water.

5. A topically applicable pharmaceutical composition comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a topically applicable, pharmaceutically acceptable aqueous gel comprising at least one carbomer gelling agent and wherein the sole anti-acne ingredient is adapalene.

6. The topically applicable pharmaceutical composition as defined by claim 5, said composition comprising one or more ingredients selected from the group consisting of carbomer 940 and propylene glycol.

7. The topically applicable pharmaceutical composition as defined by claim 6, wherein the topically applicable, pharmaceutically acceptable aqueous gel is of the formula: TABLE-US-00003 Adapalene 3 mg Carbomer 940 (B F Goodrich Carbopol 980) 11 mg Disodium edetate 1 mg Methyl paraben 2 mg Poloxamer 124 2 mg Propylene glycol 40 mg Sodium hydroxide: amount required to obtain a pH 5.0 .+-. 0.3 Purified water q.s. 1 g.

8. A topically applicable pharmaceutical composition comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2 naphthanoic acid (adapalene) or pharmaceutically acceptable salt thereof relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a topically applicable, pharmaceutically acceptable cream and wherein the sole anti-acne ingredient is adapalene.

9. The topically applicable pharmaceutical composition as defined by claim 8, said composition comprising one or more ingredients selected from the group consisting of perhydrosqualene, cyclomethicone, PEG-20 methyl glucose sequistearate and methyl glucose sequistearate.

10. The topically applicable pharmaceutical composition as defined by claim 9, wherein the cream composition is of the formula: TABLE-US-00004 Adapalene 3 mg Carbomer 934 (B. F. Goodrich Carbopol 974) 4.5 mg Disodium edetate 1 mg PEG 20 methyl glucose sesquistearate 35 mg Methyl glucose sesquistearate 35 mg Glycerol 30 mg Methyl paraben 2 mg Cyclomethicone 130 mg Perhydrosqualene 60 mg Phenoxyethanol 5 mg Propyl paraben 1 mg Sodium hydroxide quantity required for pH 6.5 .+-. 0.3 Purified water q.s. 1 g.

11. A topically applicable pharmaceutical composition comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid or pharmaceutically acceptable salt thereof relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutically acceptable medium therefor, said composition being in the form of a topically applicable, pharmaceutically acceptable polyethylene glycol-based alcoholic lotion and wherein the sole anti-acne ingredient is adapalene.

12. The topically applicable pharmaceutical composition as defined by claim 5, further comprising inert additives or combinations of inert additives, said additives being selected from the group consisting of: wetting agents; flavor enhancers; preserving agents; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; and antioxidants.

13. The topically applicable pharmaceutical composition as defined by claim 8, further comprising inert additives or combinations of inert additives, said additives being selected from the group consisting of: wetting agents; flavor enhancers; preserving agents; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; and antioxidants.

14. The topically applicable pharmaceutical composition as defined by claim 11, further comprising inert additives or combinations of inert additives, said additives being selected from the group consisting of: wetting agents; flavor enhancers; preserving agents; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; and antioxidants.

15. A topically applicable pharmaceutical composition comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or pharmaceutically acceptable salt thereof relative to the total weight of the composition, effective for the treatment of acne, formulated into a topically applicable, pharmaceutical medium therefor, wherein adapalene is the only active anti-acne ingredient in the composition, said composition being in the form of a topically applicable, pharmaceutically acceptable aqueous gel comprising at least one carbomer gelling agent.
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