Topical compositions
AssigneeBausch Health Ireland Limited
InventorsArturo J. ANGEL, Radhakrishnan S. PILLAI, Nayan DESAI
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Abstract
The disclosure provides a formulation and method for treating dermatological conditions, such as atopic dermatitis, in a patient comprising administering to the affected area of a patient a topical pharmaceutical composition comprising a therapeutically active vehicle and, optionally, one or more additional active agents.
Claims91
A method for treating atopic dermatitis (AD) in a subject in need thereof, comprising administering to the affected area a topical pharmaceutical lotion comprising a therapeutically active vehicle, wherein the therapeutically active vehicle comprises:
- an oil phase comprising:
- 10 wt. % to 15 wt. % Fatty alcohols selected from Oleyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, and combinations thereof;
- 10 wt. % to 20 wt. % Medium-chain triglycerides;
- and
- 1 wt. % to 3 wt. % Mono-glycerides and Di-glycerides;
- a viscosity modifying agent comprising 0.05 wt. % to 1 wt. % Carbomer Homopolymer Type A;
- a water phase comprising:
- 0.5 wt. % to 2 wt. % Sodium Cetostearyl Sulfate;
- and
- 25 wt. % to 75 wt. % Water;
- one or more preservatives comprising 0.5 wt. % to 2 wt. % benzyl alcohol;
- one or more buffers comprising:
- 0.025 wt. % to 0.2 wt. % Citric Acid;
- and
- Sodium Hydroxide, quantum satis (q.s.) to pH 5-7.5.
The method of any foregoing claim, wherein the oil phase comprises 2 wt. % Mono-glycerides and Di-glycerides.
The method of any foregoing claim, wherein the viscosity modifying agent comprises 0.2 wt. % Carbomer Homopolymer Type A.
The method of any foregoing claim, wherein the water phase comprises 1 wt. % Sodium Cetostearyl Sulfate.
The method of any foregoing claim, wherein the one or more preservatives comprise 1 wt. % benzyl alcohol.
The method of any foregoing claim, wherein the one or more buffers comprise 0.05 wt. % citric acid.
The method of any foregoing claim, wherein the Sodium Hydroxide is q.s. to pH 5.5.
The method of any foregoing claim, wherein the AD is moderate to severe AD.
The method of any foregoing claim wherein the topical pharmaceutical lotion is an emulsion.
The method of any foregoing claim wherein the topical pharmaceutical lotion is administered to the affected area twice daily.
The method of any foregoing claim wherein the duration of treatment is at least four weeks.
The method of any foregoing claim wherein the duration of treatment is six weeks.
The method of any foregoing claim wherein the atopic dermatitis is severe atopic dermatitis.
The method of any foregoing claim wherein the subject at the start of treatment exhibits moderate to severe AD, characterized by:
- (a) clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification, wherein oozing or crusting may be present;
- or
- (b) marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification, wherein the disease is wide-spread in extent, and wherein oozing or crusting may be present.
The method of any foregoing claim wherein the subject at the start of treatment exhibits severe AD, characterized by marked erythema (deep or bright red), marked induration/papulation, and/or marked lichenification, wherein the disease is wide-spread in extent, and wherein oozing or crusting may be present.
The method of any foregoing claim wherein the subject at the start of treatment has an Investigator Global Assessment (IGA) Scale score of greater than 3.
The method of any foregoing claim wherein the subject at the start of treatment has an EASI score of greater than 21.
The method of any foregoing claim wherein the subject exhibits at least a 2-grade reduction in the Investigator Global Assessment (IGA) Scale and exhibits an IGA that equates to “Clear” (0) or “Almost Clear” (1) after at least four weeks of treatment, e.g., after six weeks of treatment.
The method of any foregoing claim wherein the subject exhibits 75% reduction in the Eczema Area Severity Index (EASI) score after at least four weeks of treatment, e.g., after six weeks of treatment.
The method of any foregoing claim wherein the subject exhibits at least a 1 grade improvement from baseline in the severity of pruritus score and a pruritus score equating to “none” or “mild” after at least one week of treatment, e.g., after two weeks of treatment.
The method of any foregoing claim wherein the topical pharmaceutical lotion comprises an additional active agent.
A method for treating moderate to severe atopic dermatitis (AD) in a subject in need thereof, comprising administering to the affected area a topical pharmaceutical lotion comprising 0.5-1.5 wt. % pimecrolimus.
A topical pharmaceutical lotion comprising a therapeutically active vehicle, wherein the therapeutically active vehicle comprises:
- an oil phase comprising:
- 10 wt. % to 15 wt. % Fatty alcohols selected from Oleyl Alcohol, Cetyl Alcohol, Stearyl Alcohol, and combinations thereof;
- 10 wt. % to 20 wt. % Medium-chain triglycerides;
- and
- 1 wt. % to 3 wt. % Mono-glycerides and Di-glycerides;
- a viscosity modifying agent comprising 0.05 wt. % to 1 wt. % Carbomer Homopolymer Type A;
- a water phase comprising:
- 0.5 wt. % to 2 wt. % Sodium Cetostearyl Sulfate;
- and
- 25 wt. % to 75 wt. % Water;
- one or more preservatives comprising 0.5 wt. % to 2 wt. % benzyl alcohol;
- one or more buffers comprising:
- 0.025 wt. % to 0.2 wt. % Citric Acid;
- and
- Sodium Hydroxide, quantum satis (q.s.) pH 5-7.5.
The topical pharmaceutical lotion of claim 65 or 67, wherein the oil phase comprises 15 wt. % Medium-chain triglycerides.
The topical pharmaceutical lotion of claims 65-68, wherein the oil phase comprises 2 wt. % Mono-glycerides and Di-glycerides.
Dependencies are inferred from the claim text.