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Claims for Patent: 7,737,181

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Claims for Patent: 7,737,181

Title:Pharmaceutical compositions comprising 0.3% by weight 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, notably common acne, are treated with topically applicable pharmaceutical compositions containing about 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 formulated into topically applicable gels, preferably aqueous gels, creams, lotions or solutions.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Czernielewski; Janusz (Boit, FR)
Assignee: Galderma Research & Development (Biot, FR)
Application Number:11/494,693
Patent Claims: 1. A topically applicable pharmaceutical aqueous gel composition useful for the treatment of common acne, consisting essentially of an anti-acne effective amount of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) of 0.3% by weight thereof, formulated into a topically applicable, pharmaceutically acceptable aqueous gel medium therefor, wherein adapalene is the only active anti-acne ingredient in the composition and wherein said aqueous gel medium comprises at least one ingredient selected from the group consisting of carbomers, polymeric emulsifying agents, polysaccharidic biopolymers, gums, alginates, modified celluloses, starch derived products, mix of polysorbate 80 and isohexadecane and acrylamide/sodium acryloyldimethyltaurate, and mixtures thereof.

2. The topically applicable aqueous gel composition as defined by claim 1, wherein said aqueous gel medium comprises: Carbomer, Disodium edetate, Methyl paraben, Poloxamer 124, Propylene glycol, Sodium hydroxide, and Purified water.

3. A topically applicable pharmaceutical aqueous gel composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00013 Adapalene 3 mg Carbomer 940 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 and Purified water q.s. 1 g.

wherein adapalene is the only active anti-acne ingredient in the composition.

4. The topically applicable aqueous gel composition as defined by claim 1, wherein said aqueous gel medium comprises: TABLE-US-00014 Xanthan gum Hydroxypropylethylcellulose Disodium edetate Methyl paraben Phenoxyethanol Poloxamer 124 Propylene glycol Purified water.

5. A topically applicable pharmaceutical aqueous gel composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00015 Adapalene 3 mg Xanthan gum 8 mg Hydroxypropylethylcellulose 10 mg Disodium edetate 1 mg Methyl paraben 2 mg Phenoxyethanol 10 mg Poloxamer 124 2 mg Propylene glycol 40 mg Purified water q.s. 1 g,

wherein adapalene is the only active anti-acne ingredient in the composition.

6. A topically applicable pharmaceutical aqueous cream gel composition useful for the treatment of common acne, consisting essentially of an anti-acne effective amount of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) of 0.3% by weight thereof, formulated into a topically applicable, pharmaceutically acceptable aqueous cream gel medium therefor, wherein adapalene is the only active anti-acne ingredient in the composition.

7. The topically applicable aqueous cream gel composition as defined by claim 6, comprising wherein said aqueous cream gel medium comprises: TABLE-US-00016 Adapalene, Simulgel 600 PHA Cetearyl isononanoate Disodium edetate, Methyl paraben, Poloxamer 124, Propylene glycol, Purified water.

8. A topically applicable pharmaceutical aqueous cream gel composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00017 Adapalene 3 mg Simulgel 600 PHA 20 mg Cetearyl isonananoate 100 mg Disodium edetate 1 mg Methyl paraben 2 mg Poloxamer 124 2 mg Propylene glycol 40 mg Purified water q.s. 1 g,

wherein adapalene is the only active anti-acne ingredient in the composition.

9. The topically applicable aqueous cream gel composition as defined by claim 6, wherein said aqueous cream gel medium comprises: TABLE-US-00018 Adapalene Pemulen TR1 Mineral Oil Disodium edetate Methyl paraben Proply paraben Poloxamer 124 Sodium hydroxide: amount required to obtain a pH 5.0 +/- 0.3 Purified water.

10. A topically applicable pharmaceutical aqueous cream gel composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00019 Adapalene 3 mg Pemulen TR1 5 mg Mineral oil 120 mg Disodium edetate 1 mg Methyl paraben 2 mg Propyl paraben 1 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,

wherein adapalene is the only active anti-acne ingredient in the composition.

11. A topically applicable pharmaceutical cream composition useful for the treatment of common acne, consisting essentially of an anti-acne effective amount of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) of 0.3% by weight thereof, formulated into a topically applicable, pharmaceutically acceptable cream medium therefor, wherein adapalene is the only active anti-acne ingredient in the composition.

12. The topically applicable cream composition as defined by claim 11, wherein said cream medium comprises at least one ingredient selected from the group consisting of silicone oils, siliconed oily substances, siliconed fatty substances, non-siliconed fatty substances, vegetable oils, mineral oils, animal oils and synthetic oils, and mixtures thereof.

13. The topically applicable cream composition as defined by claim 12, wherein said cream medium comprises at least one ingredient selected from the group consisting of perhydrosqualene, cyclomethicone, PEG-20 methyl glucose sequistearate, methyl glucose sequistearate, and mixtures thereof.

14. The topically applicable cream composition as defined by claim 11, wherein said cream medium comprises: TABLE-US-00020 Adapalene Carbomer 934 (BF Goodrich Carbopol 974) Disodium edetate PEG 20 methyl glucose sesquistearate Methyl glucose sesquistearate Glycerol Methyl paraben Cyclomethicone Perhydrosqualene Phenoxyethanol Propyl paraben Sodium hydroxide quantity required for pH 6.5 +/- 0.3 Purified water.

15. A topically applicable pharmaceutical cream composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00021 Adapalene 3 mg Carbomer 934 (BF 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,

wherein adapalene is the only active anti-acne ingredient in the composition.

16. A topically applicable pharmaceutical aqueous lotion composition useful for the treatment of common acne consisting essentially of an anti-acne effective amount of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) of 0.3% by weight thereof, formulated into a topically applicable, pharmaceutically acceptable aqueous lotion medium therefor, wherein adapalene is the only active anti-acne ingredient in the composition.

17. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises at least one ingredient selected from the group consisting of humectant agent, pro-penetrant agent, propylene glycol, PEG400, mineral oils, lipophilic substances, caprilic/capric triglycerides, emulsifying agent, and mixtures thereof.

18. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises at least one ingredient selected from the group consisting of propylene glycol, glycerine, sorbitol, polyethylene glycol, mineral oils, perhydrosqualene, caprilic/capric triglycerides, PEG-20 methyl glucose sequistearate, methyl glucose sequistearate, and mixtures thereof.

19. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises: TABLE-US-00022 Adapalene Methyl paraben Simulgel 600 PHA Steareth 21 Glyceryl and PEG 100 stearate Disodium edetate Propyl paraben Perhydrosqualene Cetearyl isononanoate Sodium Hydroxide 10% m/m Purified water.

20. A topically applicable pharmaceutical aqueous lotion composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00023 (% w/w) Adapalene 0.30 Methyl paraben 0.15 Simulgel 600 PHA 1.00 Steareth 21 3.00 Glyceryl and PEG 100 stearate 3.00 Disodium edetate 0.10 Propyl paraben 0.05 Perhydrosqualene 5.00 Cetearyl isononanoate 5.00 Sodium Hydroxide 10% m/m q.s. pH 5.5 .+-. 0.5 Purified water q.s. 100,

wherein adapalene is the only active anti-acne ingredient in the composition.

21. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises: TABLE-US-00024 Disodium EDTA Methyl paraben Glycerine Carbopol 981 NF Propyl paraben Ceteareth 20 Stearyl alcohol Caprilic/capric triglycerides Glyceryl and PEG 100 stearate Cyclomethicone 5 Poloxamer 124 Propylene glycol Simulgel 600 PHA Solution aq. De NaOH 10% Purified water.

22. A topically applicable pharmaceutical aqueous lotion composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00025 (% w/w) Disodium EDTA 0.1 Methyl paraben 0.2 Glycerine 7.0 Carbopol 981 NF 0.15 Propyl paraben 0.1 Ceteareth 20 3.0 Stearyl alcohol 2.0 Caprilic/capric triglycerides 7 Glyceryl and PEG 100 stearate 3.0 Cyclomethicone 5 6 Poloxamer 124 0.2 Propylene glycol 4.0 Adapalene 0.3 Simulgel 600 PHA 1.0 Solution aq. De NaOH 10% 0.4 Purified water q.s. 100,

wherein adapalene is the only active anti-acne ingredient in the composition.

23. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises: TABLE-US-00026 EDTA disodium Methyl paraben Carbopol 980 NF Carbopol 981 NF Gylcerine Phenoxyethanol Propyl paraben Methyl glucose sesquistearate PEG 20 methyl glucose sesquistearate Caprilic/capric triglycerides Dimethicone 20 cst Poloxamer 124 Propylene glycol Sodium Hydroxide 10% m/m Purified water.

24. A topically applicable pharmaceutical aqueous lotion composition useful for the treatment of common acne consisting essentially of: TABLE-US-00027 (% w/w) Disodium EDTA 0.1 Methyl paraben 0.2 Glycerine 7.0 Carbopol 981 NF 0.15 Propyl paraben 0.1 Ceteareth 20 3.0 Stearyl alcohol 2.0 Caprilic/capric triglycerides 7 Glyceryl and PEG 100 stearate 3.0 Cyclomethicone 5 6 Poloxamer 124 0.2 Propylene glycol 4.0 Adapalene 0.3 Simulgel 600 PHA 1.0 Solution aq. De NaOH 10% 0.4 Purified water q.s. 100,

wherein adapalene is the only active anti-acne ingredient in the composition.

25. A topically applicable pharmaceutical spray solution composition useful for the treatment of common acne consisting essentially of an anti-acne effective amount of 6-[3-(1-adamantyl) -4-methoxyphenyl]-2-naphthanoic acid (adapalene) of 0.3% by weight thereof, formulated into a topically applicable, pharmaceutically acceptable spray solution medium therefor, said spray solution medium comprising caprilic/capric triglycerides, wherein adapalene is the only active anti-acne ingredient in the composition.

26. The topically applicable spray solution composition as defined by claim 25, wherein said spray solution medium further comprises at least one ingredient selected from the group consisting of humectant agent, pro-penetrant agent, propylene glycol, polyethylene glycol, PEG400, a lipophilic substance, siliconed fatty substances, non-siliconed fatty substances, and mixtures thereof.

27. The topically applicable spray solution composition as defined by claim 25, wherein said spray solution medium comprises: Caprilic/capric triglycerides, N-methyl pyrrolidone, and Ethanol.

28. A topically applicable pharmaceutical spray solution composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00028 (% w/w) Adapalene 0.3 Caprilic/capric triglycerides 50 N-methyl pyrrolidone 3 Ethanol q.s. 100,

wherein adapalene is the only active anti-acne ingredient in the composition.

29. The topically applicable aqueous gel composition as defined by claim 1, wherein said aqueous gel medium comprises at least one inert additive selected from the group consisting of: wetting agents; flavor enhancers; preservatives; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; Antioxidants; and combinations thereof.

30. The topically applicable aqueous cream gel composition as defined by claim 6, wherein said aqueous cream gel medium comprises at least one inert additive selected from the group consisting of: wetting agents; flavor enhancers; preservatives; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; Antioxidants; and combinations thereof.

31. The topically applicable cream composition as defined by claim 11, wherein said cream medium comprises at least one inert additive selected from the group consisting of: wetting agents; flavor enhancers; preservatives; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; Antioxidants; and combinations thereof.

32. The topically applicable aqueous lotion composition as defined by claim 16, wherein said aqueous lotion medium comprises at least one inert additive selected from the group consisting of: wetting agents; flavor enhancers; preservatives; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; Antioxidants; and combinations thereof.

33. The topically applicable spray solution composition as defined by claim 25, wherein said spray solution medium comprises at least one inert additive selected from the group consisting of: wetting agents; flavor enhancers; preservatives; stabilizers; moisture regulators; pH regulators; osmotic pressure modifiers; emulsifiers; UV-A and UV-B screening agents; Antioxidants; and combinations thereof.

34. The topically applicable pharmaceutical aqueous lotion composition useful for the treatment of common acne, consisting essentially of: TABLE-US-00029 (% w/w) EDTA disodium 0.1 Methyl paraben 0.2 Carbopol 980 NF 0.15 Carbopol 981 NF 0.3 Gylcerine 3.0 Phenoxyethanol 1.0 Propyl paraben 0.2 Methyl glucose sesquistearate 1.0 PEG 20 methyl glucose sesquistearate 5.0 Caprilic/capric triglycerides 6.0 Dimethicone 20 cst 1.0 Poloxamer 124 0.2 Propylene glycol 4 Adapalene 0.3 Sodium Hydroxide 10% m/m 0.8 Purified water q.s. 100.

35. The topically applicable aqueous gel composition as defined by claim 1, wherein said aqueous gel medium comprises at least one carbomer.

36. The topically applicable aqueous gel composition as defined by claim 1, wherein said aqueous gel medium comprises carbomer 940.
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