DERMATOLOGICAL FOAMS OBTAINED FROM A GEL OR SUSPENSION CONTAINING A COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE

• US 20130317108A1
• Filed: 12/22/2011
• Published: 11/28/2013
• Est. Priority Date: 12/23/2010
• Status: Abandoned Application

• Current Assignee: Galderma Research And Development Snc (Nestle SA)
• Original Assignee: Galderma Research And Development Snc (Nestle SA)
• Inventors: At, Emmanuelle
• Application Number:
  US13/997,125
• Publication Number:
  US 20130317108A1
• Time in Patent Office: Days
• US Class Current: 514/569
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/327 Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61K 8/368 with carboxyl groups directly bound to carbon atoms of aromatic rings
• CPC Class Codes: A61K 8/38 Percompounds, e.g. peracids
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 17/10 Anti-acne agents
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

Intermediate compositions, and in particular gels and suspensions for foam compositions, are described that include adapalene and benzoyl peroxide in combination. Also described; is the dermatological use of such compositions.

Claims

1. A composition comprising a combination of adapalene and benzoyl peroxide wherein the composition is in the form of a foam and is obtained from an intermediate composition in the form of a gel or a suspension.

2. The composition as defined by claim 1, wherein the intermediate composition has a viscosity of greater than 8,000 cps.

3. The composition as defined by claim 1, wherein the composition has a viscosity of between 8000 8,000 cps and 32 000 32,000 cps.

4. The composition as defined by claim 1, wherein the composition comprises:

between 60% and 98% by weight, relative to the total weight of the composition, of a gel or suspension, and

between 2% and 40% by weight, relative to the total weight of the composition, of at least one propellant gas.

9. A method of treating a keratinization disorder, the method comprising administering to a subject in need thereof a composition as defined by claim 1.

13. The composition as defined by claim 4, wherein the gel or suspension is present in an amount from 80% to 96% by weight, relative to the total weight of the composition.

14. The composition as defined by claim 4, wherein the at least one propellant is present in an amount from 4% to 20% by weight, relative to the total weight of the composition.

16. The intermediate composition as defined by claim 13, wherein the at least one gelling agent and/or pH-independent gelling agent for the aqueous phase is present in an amount from 0.2% to 5%, as a weight percentage relative to the total weight of the composition.

18. the method as defined by claim 9, wherein the keratinization disorder is acne.

5. An intermediate composition in gel form, the intermediate composition comprising in a physiologically acceptable medium:

adapalene and benzoyl peroxide,

water,

at least one gelling agent and/or pH-independent gelling agent,

at least one surfactant,

at least one wetting agent,

optionally, a chelating agent,

optionally, at least one humectant and/or emollient,

optionally, one or more additives.

7. The intermediate composition as defined by claim 5, wherein the composition comprises, as a weight percentage relative to the total weight of the composition, from 0.1% to 10% of at least one gelling agent and/or pH-independent gelling agent for the aqueous phase.

10. The intermediate composition in gel or suspension form as defined by claim 5, comprising on a weight basis relative to the total weight of the gel or suspension:

(a) 0.01% to 5% of adapalene and 2% to 7% of benzoyl peroxide in combination;

(b) 65% to 85% of water;

(c) 0.2% to 5% of at least one gelling agent and/or pH-independent gelling agent for the aqueous phase;

(d) 0% to 5% of at least one suspension agent and/or viscosity enhancer;

(e) 0.5% to 10% of at least one surfactant;

(f) 0.1% to 8% of at least one wetting agent;

(g) 0% to 1% of a chelating agent;

(h) 0% to 15% of at least one humectant and/or emollient; and

(i) 0% to 15% of one or more additives.

11. The intermediate composition as defined by claim 10, wherein the content of surfactant (e) is between 2% and 10% by weight relative to the total weight of the composition.

17. The intermediate composition as defined by claim 7, wherein the at least one gelling agent and/or pH-independent gelling agent is present in an amount of from 0.2% to 5%, as a weight percentage relative to the total weight of the composition.

6. An intermediate composition in suspension form, the intermediate composition comprising in a physiologically acceptable medium:

adapalene and benzoyl peroxide,

water,

at least one gelling agent and/or pH-independent gelling agent,

optionally, one or more suspension agents,

at least one surfactant,

at least one wetting agent,

optionally, a chelating agent,

optionally, at least one humectant and/or emollient,

optionally, one or more additives.

8. The intermediate composition as defined by claim 6, wherein the adapalene and benzoyl peroxide are in dispersed form in the composition.

12. A process for obtaining the intermediate composition as defined by claim 6, the process comprising combining, in a physiologically acceptable medium:

adapalene and benzoyl peroxide;

water;

gelling agent and/or pH-independent gelling agent;

suspension agents;

surfactant;

wetting agent;

chelating agent;

humectant and/or emollient, and optionally, one or more additives.

15. The intermediate composition as defined by claim 6, wherein the composition comprises, as a weight percentage relative to the total weight of the composition, from 0.1% to 10% of at least one gelling agent and/or pH-independent gelling agent for the aqueous phase.