Pharmaceutical and cosmeceutical wash-off mousse shampoo compositions, processes for preparing the same and uses thereof

• US 20060057075A1
• Filed: 08/02/2005
• Published: 03/16/2006
• Est. Priority Date: 08/02/2004
• Status: Abandoned Application

• Current Assignee: Perrigo Israel Pharmaceuticals Limited (Perrigo Company PLC)
• Original Assignee: Perrigo Israel Pharmaceuticals Limited (Perrigo Company PLC)
• Inventors: Buriakovsky, Olga, Zeevi, Amira, Arkin, Moshe, Hollander, Erez, Uzan, Rina, Avram, Nir, Shilo-Volin, Hagit
• Application Number:
  US11/194,582
• Publication Number:
  US 20060057075A1
• Time in Patent Office: Days
• US Class Current: 424/47
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61K 8/45 Derivatives containing from 2 to 10 oxyalkylene groups
• CPC Class Codes: A61K 8/463 containing sulfuric acid derivatives, e.g. sodium lauryl sulfate
• CPC Class Codes: A61K 8/49 containing heterocyclic compounds
• CPC Class Codes: A61K 8/4993 Derivatives containing from 2 to 10 oxyalkylene groups
• CPC Class Codes: A61K 8/63 Steroids; Derivatives thereof
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• 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 9/12 Aerosols; Foams A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/04 Antipruritics
• CPC Class Codes: A61P 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/08 Antiseborrheics
• CPC Class Codes: A61P 17/10 Anti-acne agents
• CPC Class Codes: A61P 17/12 Keratolytics, e.g. wart or anti-corn preparations
• CPC Class Codes: A61P 17/14 for baldness or alopecia
• CPC Class Codes: A61P 17/18 Antioxidants, e.g. antiradicals preparations for protection against sunlight A61Q17/00
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/10 : Antimycotics
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 33/00 : Antiparasitic agents
• CPC Class Codes: A61P 33/10 : Anthelmintics
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 7/10 : Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/08 : Vasodilators for multiple indications
• CPC Class Codes: A61Q 5/006 : Antidandruff preparations
• CPC Class Codes: A61Q 5/02 : Preparations for cleaning the hair

Abstract

A pharmaceutical or cosmeceutical mousse shampoo composition formulated for application to hirsute areas, such as the human scalp, and containing an active pharmaceutical ingredient as well as a cleansing agent is disclosed. Methods of treatment using the same and processes of preparing the same are also disclosed.

Claims

1. A pharmaceutical or cosmeceutical wash-off mousse shampoo composition formulated for topical application to the skin and/or scalp of a mammal comprising:

(a) a cleansing agent;

(b) a cosmeceutically or pharmaceutically effective amount of at least one active pharmaceutical ingredient; and

(c) a pharmaceutically acceptable mousse-forming carrier.

2. The wash-off mousse shampoo composition of claim 1, formulated to be applied either to dry hair or wet hair.

3. The wash-off mousse shampoo composition of claim 1, wherein at least one of said at least one active pharmaceutical ingredient is for the treatment of a skin and/or scalp disease and disorder.

4. The wash-off mousse shampoo composition of claim 1, wherein the concentration of said at least one active pharmaceutical ingredient is at least about 0.01 weight percentages of the total weight of the composition.

5. The wash-off mousse shampoo composition of claim 1, wherein said active pharmaceutical ingredient is at least one topically active pharmaceutical ingredient selected from the group consisting of active herbal extracts, acaricides, age spot and keratose removing agents, analgesics, local anesthetics, antiacne agents, antiaging agents, antibacterials, antibiotics, antiburn agents, antidandruff agents, antidepressants, antidermatitis agents, antiedemics, antihistamines, antihelminths, antihyperkeratolyte agents, antiinflammatory agents, antiirritants, antilipemics, antimicrobials, antimycotics, antioxidants, antipruritics, antipsoriatic agents, antirosacea agents, antiseborrheic agents, antiseptic, antiswelling agents, antiviral agents, antiyeast agents, astringents, topical cardiovascular agents, chemotherapeutic agents, corticosteroids, fungicides, hair growth regulators, hormones, hydroxyacids, insecticides, keratolytic agents, lactams, mitocides, non-steroidal anti-inflammatory agents, pediculicides, progestins, sanatives, scabicides, vasodilators and wart removers.

6. The wash-off mousse shampoo composition of claim 1, wherein said mousse-forming carrier comprises a propellant.

7. The wash-off mousse shampoo composition of claim 6, wherein an amount of said propellant ranges between about 3 weight percentages and about 50 weight percentages of the total weight of the composition.

8. The wash-off mousse shampoo composition of claim 6, wherein said pharmaceutically acceptable mousse-forming carrier further comprises at least one foam-forming agent.

9. The wash-off mousse shampoo composition of claim 8, wherein said at least one foam-forming agent comprises at least one surface-active agent.

10. The wash-off mousse shampoo composition of claim 6, wherein said pharmaceutically acceptable mousse-forming carrier further comprises at least one additional component selected from the group consisting of an emulsifier, a fatty alcohol, a hydrocarbon alcohol and water.

11. The wash-off mousse shampoo composition of claim 1, further comprising at least one additional ingredient selected from the group consisting of an anti-perspirant, an anti-static agent, a buffering agent, a wetting agent, a bulking agent, a chelating agent, a colorant, a conditioner, a deodorant, a diluent, a dye, an emollient, a fragrance, a hair conditioner, a humectant, an occlusive agent, an oil, a penetration enhancer, a pearlescent aid, a perfuming agent, a permeation enhancer, a pH-adjusting agent, a preservative, a protectant, a skin penetration enhancer, a softener, a solubilizer, a sunscreen, a sun blocking agent, a sunless tanning agent, a viscosity modifier and a vitamin.

12. The wash-off mousse shampoo composition of claim 1, packaged in a packaging material and identified in print, in or on said packaging material, for use in the treatment of a skin and/or scalp disease or disorder.

13. The wash-off mousse shampoo composition of claim 12, wherein said skin and/or scalp disease or disorder is selected from the group consisting of acne, acne rosacea, actinic keratoses, actinic porokeratosis, acute inflammatory diseases, age spots, allergic contact dermatitis, alopecia, asteatotic eczema, atopic dermatitis, atopic eczema, bacterial infection, BCC, Bowen'"'"'s disease, burns, chronic hypertrophic lichen planus, chronic superficial scaling, contact dermatitis, cradle cap, cutaneous T-cell lymphoma, cystic acne, dandruff, Darier'"'"'s disease, dermatitis, dermatitis herpetiformis, dermatosis, discoid eczema, discoid lupus erythematosus, dry skin, eczema, erythrasma, exfoliative keratolysis, folliculitis, fungal infection, juvenile plantar dermatosis, granuloma annulare, Grover'"'"'s disease, hair thinning, ichthyosiform dermatoses, ichthyosis, impetigo, infantile eczema, infection, intertrigo, keratosis, keloid scarsm lichen simplex chronicus, lichen planus, lichen striatus, lupus erythematosus, neurodermatitis, palmar hyperkeratosis, palmoplantar psoriasis, papular urticaria, parapsoriasis, pediculosis, pellagra, perifolliculitis, pigmented skin, lesions, pityriasis alba, pityriasis lichenoides, pityriasis rosea, pityriasis rubra pilaris, pityriasis versicolor, plantar hyperkeratosis, neurodermatitis, pruritis, psoriasis, Reiter'"'"'s syndrome, rosacea, seborrhoeic dermatitis, subacute cutaneous lupus erythematosus, tinea capitis, superficial BCC, warts, wound, wrinkles and yeast infections, Malassezia ovalis infection, Malassezia furfur infection, Pityrosporium orbiculare infection and Pityrosporium ovale infection.

14. A process of preparing the pharmaceutical or cosmeceutical wash-off mousse shampoo composition of claim 1, the process comprising:

(a) obtaining a mixture of;

i) a cleansing agent;

ii) at least one active pharmaceutical ingredient;

iii) a pharmaceutically acceptable mousse-forming carrier;

(b) placing said mixture in a pressure-resistant vessel; and

(c) sealing said pressure-resistant vessel.

15. The process of claim 14, wherein said mousse-forming carrier comprises a propellant and placing said mixture in a pressure-resistant vessel comprises:

placing said mixture in a pressure-resistant vessel;

fitting said pressure-resistant vessel with a seal-valve;

placing said propellant in said pressure-resistant vessel; and

fitting said seal-valve with an actuator.

16. A method of treating a skin and/or scalp disease or disorder, the method comprising:

(a) co-administering to a skin and/or scalp area afflicted by the skin and/or scalp disease or disorder of a mammal in need thereof a therapeutically or cosmeceutically effective amount of at least one active pharmaceutical ingredient simultaneously with a cleansing agent in a mousse form;

(b) subsequent to said co-administering, waiting a period of time; and

(c) subsequent to said waiting, rinsing said area.

17. The method of claim 16, wherein said skin and/or scalp area is a hirsute area.

18. The method of claim 16, wherein prior to said administering, said skin and/or scalp is made wet.

19. The method of claim 16, wherein prior to said administering, said skin and/or scalp is dry.

20. The method of claim 16, wherein said period of time is less than about 20 minutes.

21. The method of claim 16, wherein said skin and/or scalp disorder is selected from the group consisting of acne, acne rosacea, actinic keratoses, actinic porokeratosis, acute inflammatory diseases, age spots, allergic contact dermatitis, alopecia, asteatotic eczema, atopic dermatitis, atopic eczema, bacterial infection, BCC, Bowen'"'"'s disease, burns, chronic hypertrophic lichen planus, chronic superficial scaling, contact dermatitis, cradle cap, cutaneous T-cell lymphoma, cystic acne, dandruff, Darier'"'"'s disease, dermatitis, dermatitis herpetiformis, dermatosis, discoid eczema, discoid lupus erythematosus, dry skin, eczema, erythrasma, exfoliative keratolysis, folliculitis, fungal infection, juvenile plantar dermatosis, granuloma annulare, Grover'"'"'s disease, hair thinning, ichthyosiform dermatoses, ichthyosis, impetigo, infantile eczema, infection, intertrigo, keratosis, keloid scarsm lichen simplex chronicus, lichen planus, lichen striatus, lupus erythematosus, neurodermatitis, palmar hyperkeratosis, palmoplantar psoriasis, papular urticaria, parapsoriasis, pediculosis, pellagra, perifolliculitis, pigmented skin, lesions, pityriasis alba, pityriasis lichenoides, pityriasis rosea, pityriasis rubra pilaris, pityriasis versicolor, plantar hyperkeratosis, neurodermatitis, pruritis, psoriasis, Reiter'"'"'s syndrome, rosacea, seborrhoeic dermatitis, subacute cutaneous lupus erythematosus, tinea capitis, superficial BCC, warts, wound, wrinkles and yeast infections, Malassezia ovalis infections, Malassezia furfur infections, Pityrosporium orbiculare infections and Pityrosporium ovale infections.

22. The method of claim 16, wherein said active pharmaceutical ingredient is at least one topically active pharmaceutical ingredient selected from the group consisting of active herbal extracts, acaricide, age spots and keratoses removing agents, analgesics, local anesthetics, antiacne agents, antiaging agents, antibacterials, antibiotics, antiburn agents, antidandruff agents, antidepressants, antidermatitis agents, antiedemics, antihistamines, antihelminths, antihyperkeratolyte agents, antiinflammatory agents, antiirritants, antilipemics, antimicrobials, antimycotics, antioxidants, antipruritics, agents, antipsoriatic agents, antirosacea, antiseborrheic agents, antiseptic, antiswelling agents, antiviral agents, antiyeast agents, astringents, topical cardiovascular agents, chemotherapeutics, corticosteroids, fungicides, hair growth regulators, hormones, hydroxyacids, insecticides, keratolytics, lactams, mitocides, non-steroidal anti-inflammatory agents, pediculicide, progestins, sanatives, scabicide, vasodilators and wart removers.

23. The method of claim 16, wherein said cleansing agent is selected from the group consisting of cleansers, detergents and soaps.

24. The method of claim 16, wherein said at least one active pharmaceutical ingredient and said cleansing agent form a part of a pharmaceutical or cosmeceutical wash-off mousse shampoo composition.

25. The method of claim 24, wherein said pharmaceutical or cosmeceutical wash-off mousse shampoo composition further comprises a mousse-forming carrier.

26. The method of claim 25, wherein said mousse-forming carrier comprises a propellant.

27. The method of claim 26, wherein said administering is effected by passing said pharmaceutical or cosmeceutical wash-off mousse shampoo composition from a first volume having a first pressure through a passage into a second volume having a second pressure, said first pressure being greater than said second pressure, so as to effect foaming of said composition.