COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS

• US 20120136059A1
• Filed: 11/30/2011
• Published: 05/31/2012
• Est. Priority Date: 07/13/2006
• Status: Active Grant

• Current Assignee: Galderma Research And Development Snc (Nestle SA)
• Original Assignee: Galderma Research And Development Snc (Nestle SA)
• Inventors: ABOU-CHACRA VERNET, Marie-line, Gross, Denis, Loesche, Christian, Poncet, Michel
• Granted Patent: US 8,445,543 B2
• 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 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• 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 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• 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 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: A61P 17/10 Anti-acne agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.

Claims

1. A regime or regimen for reducing the number of acne lesions, comprising administering to an individual afflicted therewith, a thus effective amount of a pharmaceutical composition which comprises adapalene or a pharmaceutically acceptable salt thereof, administered in combination or in a concomitant application with benzoyl peroxide.

2. The regime or regimen as defined by claim 1, comprising administering a pharmaceutical composition which comprises fixed combination which comprises (i) at least one compound selected from among adapalene and pharmaceutically acceptable salts thereof, and (ii) benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor.

3. The regime or regimen as defined by claim 1, said acne lesions being of inflammatory and/or non-inflammatory type.

4. The regime or regimen as defined by claim 3, in which the reduction of the number of inflammatory and/or non-inflammatory acne lesions is at least about 40%.

5. The regime or regimen as defined by claim 2, comprising administering a pharmaceutical composition in which the adapalene and the benzoyl peroxide are present in synergistic amounts.

6. The regime or regimen as defined by claim 2, wherein the pharmaceutical composition comprises 0.1% of adapalene and 2.5% of benzoyl peroxide.

7. The regime or regimen as defined by claim 2, wherein the pharmaceutical composition is a gel.

8. The regime or regimen as defined by claim 1, wherein the pharmaceutical composition is adapted for topical application.

9. The regime or regimen as defined by claim 1, wherein the pharmaceutical composition is in the form of a composition A comprising adapalene, to be applied concomitantly with a composition B comprising benzoyl peroxide.

10. The regime or regimen as defined by claim 9, wherein the adapalene and the benzoyl peroxide are present, respectively, in compositions A and B in synergistic amounts.

11. The regime or regimen as defined by claim 9, wherein composition A comprises 0.1% of adapalene and composition B comprises 2.5% of benzoyl peroxide.

12. The regime or regimen as defined by claim 9, wherein the compositions A and B are gels.

13. The regime or regimen as defined by claim 9, wherein the composition A and composition B are presented in the form of a kit.

14. The regime or regimen as defined by claim 13, wherein the kit comprises two isolated compartments each containing one of the two pharmaceutical compositions A or B.

15. The regime or regimen as defined by claim 13, wherein the kit comprises at least one association of the two compositions A and B, in two separate packages in the same presentation.

16. The regime or regimen as defined by claim 9, wherein the said pharmaceutical composition is composition A, to be applied in any order or sequentially, within a time interval of less than 1 hour, with composition B.

17. The regime or regimen as defined by claim 9, wherein the compositions A and B are adapted for topical application.

18. The regime or regimen as defined by claim 3, wherein the pharmaceutical composition is useful for reducing the number of inflammatory acne lesions.

19. The regime or regimen as defined by claim 3, wherein the pharmaceutical composition is useful for reducing the number of non-inflammatory acne lesions.

20. A method for potentiating the action of benzoyl peroxide, comprising administering therewith adapalene or a pharmaceutically acceptable salt thereof.

21. A kit comprising at least two components:

a first component which comprises at least adapalene or a pharmaceutically acceptable salt thereof, and

a second component which comprises benzoyl peroxide.

22. A product comprising:

(i) a container delimiting at least one compartment, the said container being sealed by means of a closing member; and

(ii) a pharmaceutical composition which comprises adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide, confined inside the said compartment.