Method of treating a skin disease with a corticosteroid-containing pharmaceutical composition

• US 6,126,920 A
• Filed: 01/12/1998
• Issued: 10/03/2000
• Est. Priority Date: 03/03/1995
• Status: Expired due to Term

• Current Assignee: Stiefel West Coast, LLC
• Original Assignee: Medeva Europe, PLC
• Inventors: Jones, Julie Irene, Halls, Neil Graham, Baker, Anthony Richard, Watmough, Peter, Marriott, Peter
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Berman, Alysia
• Application Number:
  US08/913,144
• Time in Patent Office: 995 Days
• Field of Search: 424/45, 514/945
• US Class Current: 424/45
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• 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 9/122 Foams; Dry foams edible foams A61K9/0056
• 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 17/06 Antipsoriatics
• CPC Class Codes: A61P 17/08 Antiseborrheics

Abstract

Methods of treating various skin diseases, and in particular, scalp psoriasis, utilizing a foamable pharmaceutical composition comprising a corticosteroid active substance, a quick-break foaming agent, a propellant and a buffering agent are disclosed. The quick-break foaming agent typically comprises an aliphatic alcohol, water, a fatty alcohol and a surface active agent.

Claims

1. A method of treating a skin disease susceptible to treatment with corticosteroid active substances, said method comprising administering topically to a patient in need thereof, an effective amount of a foamable pharmaceutical composition comprising a corticosteroid active substance, a quick-break foaming agent that comprises an aliphatic alcohol, water, a fatty alcohol and a surface active agent;

a propellant; and

a buffering agent present in an amount sufficient to provide a pH within the range of 3.0 to 6.0.

2. The method according to claim 1 wherein the skin disease is selected from the group consisting of eczema, infantile eczema, atopic dermatitis, dermatitis herpetiformis, contact dermatitis, seborrheic dermatitis, neurodermatitis, psoriasis and intertrigo.

3. The method according to claim 2 for treating scalp psoriasis in human subjects.

5. The method according to claim 1, further characterized in that the amount of the corticosteroid active substance is from 0.01 to 1.0% w/w of the composition.

6. The method according to claim 1, further characterized in that the corticosteroid active substance is a topically effective corticosteroid selected from alclometasone dipropionate, amcinonide, beclamethasone dipropionate, betamethiasone benzoate, betamethasone dipropionate, betamethasone valerate, budesonide, clobetasol propionate, clobetasone butyrate, desonide, desoxymethasone, diflorasone diacetate, diflucortolone valerate, flumethasone pivalate, fluclorolone acetonide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone preparations, fluprednidene acetate, flurandrenolone, halcinonide, hydrocortisone, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone acetate, mometasone furoate, triamcinolone acetonide, and pharmacologically effective mixtures thereof.

7. The method according to claim 6, further characterized in that the corticosteroid active substance is betamethasone valerate.

8. The method according to claim 1, further characterized in that the aliphatic alcohol component is selected from the group consisting of methanol, ethanol, isopropyl alcohol, butyl alcohol, and mixtures thereof.

9. The method according to claim 8, further characterized in that the aliphatic alcohol component is ethanol.

10. The method according to claim 1, further characterized in that the fatty alcohol component is selected from cetyl, stearyl, lauryl, myristyl, and palmityl alcohols, and mixtures thereof.

11. The method according to claim 10, further characterized in that the fatty alcohol component is a mixture of cetyl alcohol and stearyl alcohol.

12. The method according to claim 1, further characterized in that the surface active agent is selected from the group consisting of ethoxylated sorbitan stearate, ethoxylated sorbitan palmitate, ethoxylated sorbitan oleate, nonyl phenol ethoxylates, fatty alcohol ethoxylates, and mixtures thereof.

13. The method according to claim 1, further characterized in that the buffering agent is selected from the group consisting of a citrate buffer, an acetic acid/sodium acetate buffer and a phosphoric acid/sodium phosphate buffer.

14. The method according to claim 13, further characterized in that the buffering agent is a citrate buffer.

15. The method according to claim 1, further characterized in that the foamable pharmaceutical composition comprises:

space="preserve" listing-type="tabular">______________________________________ % w/w ______________________________________ Betamethasone Valerate 0.120 Cetyl Alcohol BP 1.100 Octadecan-1-ol BP 0.500 Polysorbate 60 BP 0.400 Ethanol 57.790 Purified Water 33.690 Propylene Glycol BP 2.000 Citric Acid Anhydrous BP 0.073 Potassium Citrate 0.027 Butane/Propane 4.300 100.000. ______________________________________

4. A method of treating a skin disease susceptible to treatment with corticosteroid active substances, said method comprising administering topically to a patient in need thereof an effective amount of a foamable pharmaceutical composition comprised of a quick-break foaming agent that comprises an aliphatic alcohol, water, a fatty alcohol and a surface active agent a propellant;

an active isomer of an isomeric corticosteroid active substance; and

an amount of a buffering agent effective to stabilize the active isomer against isomerization to a less active isomer.