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Foamable Suspension Gel Formbares Suspensionsgel Gel De Suspension Moussant

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Foamable Suspension Gel Formbares Suspensionsgel Gel De Suspension Moussant (19) TZZ Z_Z_¥¥_T (11) EP 2 010 133 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/192 (2006.01) A61K 31/203 (2006.01) 04.05.2016 Bulletin 2016/18 A61K 31/327 (2006.01) A61K 31/63 (2006.01) A61K 31/7056 (2006.01) A61K 9/06 (2006.01) (2006.01) (2006.01) (21) Application number: 07825280.6 A61K 9/12 A61K 47/36 A61K 31/7034 (2006.01) A61K 9/00 (2006.01) (22) Date of filing: 29.03.2007 (86) International application number: PCT/IB2007/002958 (87) International publication number: WO 2008/007224 (17.01.2008 Gazette 2008/03) (54) FOAMABLE SUSPENSION GEL FORMBARES SUSPENSIONSGEL GEL DE SUSPENSION MOUSSANT (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR WO-A1-03/055472 WO-A2-02/45662 HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE WO-A2-2007/002831 WO-A2-2007/092312 SI SK TR US-A- 5 466 446 US-A- 6 013 637 Designated Extension States: US-A1- 2004 073 946 US-A1- 2004 151 671 AL BA HR MK RS US-A1- 2004 167 223 US-A1- 2004 171 561 US-A1- 2005 186 147 (30) Priority: 31.03.2006 US 744082 P • LEYDEN JAMES J ET AL: "Antibiotic-resistant (43) Date of publication of application: Propionibacterium acnes suppressed by a 07.01.2009 Bulletin 2009/02 benzoyl peroxide cleanser 6%.", CUTIS DEC 2008, vol. 82, no. 6, December 2008 (2008-12), (60) Divisional application: pages 417-421, ISSN: 0011-4162 10159385.3 / 2 206 494 • EUROPEAN PHARMACOPOEIA COMMISSION, COUNCIL OF EUROPE EUROPEAN (73) Proprietor: Stiefel Research Australia Pty Ltd DIRECTORATE FOR THE QUALITY OF Rowville VIC 3178 (AU) MEDICINES: ’European Pharmacopeia 7th edition’, pages 1468 - 1469 (72) Inventors: • ABRAM, Albert, Zorko Remarks: Wantirna, Victoria, 3152 (AU) Thefile contains technical information submitted after • FUCHSHUBER, Lilian the application was filed and not included in this Narre Warren, Victoria, 3805 (AU) specification (74) Representative: Reeves, Julie Frances GlaxoSmithKline Global Patents (CN925.1) 980 Great West Road Brentford, Middlesex TW8 9GS (GB) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 010 133 B1 Printed by Jouve, 75001 PARIS (FR) EP 2 010 133 B1 Description FIELD OF THE INVENTION 5 [0001] The present subject matter relates to topical delivery of an active agent that is sparingly soluble to insoluble in water, particularly benzoyl peroxide, in an aqueous, foamable suspension gel. BACKGROUND OF THE INVENTION 10 [0002] There are many challenges in the topical application of pharmaceutically active agents. One major objective is to achieve percutaneous delivery of the active agent to the site of treatment. The composition should also have desirable cosmetic characteristics. Application should be easy and should not leave a noticeable residue on the surface of the skin. Moreover, the composition should not cause irritation, discomfort, or inconvenience. [0003] Many antifungal and antibacterial agents are used topically to treat epidermal infections. Some antibiotics, such 15 as tetracycline and clindamycin, are also used to treat acne and other skin diseases that are caused, directly or indirectly, by bacteria. One of the side-effects of systemically administered clindamycin is colitis, which can be dangerous and even fatal. Thus, in treating acne, it is desirable to administer clindamycin topically. Cleocin T ®, manufactured by Phar- macia-Upjohn, contains clindamycin phosphate, which is inactive in vitro, but is hydrolyzed in vivo to the antibacterially active clindamycin. Cleocin T® is currently available as a gel, a lotion, and a topical solution, and is used for topical 20 treatment of acne vulgaris. [0004] Others have produced topical formulations containing a pharmaceutically active agent that is sparingly soluble to insoluble in water ( e.g., benzoyl peroxide) and a second pharmaceutically active agent ( e.g., clindamycin). For example, BenzaClin®, manufactured by Dermik Laboratories, and Duac®, manufactured by Stiefel Laboratories, each contain benzoyl peroxide and clindamycin. BenzaClin ® and Duac ® are currently available as topical gels. Others have described 25 a suspension foam containing benzoyl peroxide and clindamycin, but the foam contains oil and requires a surfactant in addition to a dispersing emulsifier. See, U.S. Patent Publication 2005/0186147. [0005] Lotion, gels and oil-based foams have the disadvantage of extended rub-in and may leave oily residues. The oil can also exacerbate acne. The solution form readily runs off the site of application, and therefore it is difficult to appl y controlled amounts using the solution form. 30 [0006] WO 03/055472 A1 is directed to an aqueous gel composition comprising a retinoid and benzoyl peroxide. [0007] US 5,466,446 A is directed to a highly stable gel composition comprising a combination of benzoyl peroxide and clindamycin. [0008] US 6,013,637 A is directed to compositions for the topical treatment of acne, comprising a peroxide and a lincomycin antibiotic. The patent describes powder, suspension, lotion, cream, gel and spray embodiments. 35 [0009] WO 2007/002831 A2 is directed to storage stable topical compositions for treating various skin disorders and conditions. The compositions comprise a mixture of benzoyl peroxide, an antibiotic and a retinoid. [0010] WO 2007/092312 A2 is directed to a composition for treating a skin disorder or condition, comprising a first storage-stable composition comprising benzoyl peroxide and a second composition comprising an antibiotic in solution and a retinoid in suspension. 40 [0011] US 2005/186147 A1 is directed to a foamable composition which includes water, a liquid non-volatile hydro- phobic solvent, optionally a foam adjuvant agent selected from the group consisting of fatty acids and fatty alcohols, a surface active agent, and a water gelling agent, and at least 2% of solid particles. The foamable compositions, when placed in an aerosol container and combined with a liquefied gas propellant, create an oil in water emulsion which upon release from the aerosol container provides a therapeutically beneficial foam product. 45 [0012] US 2004/167223 A1 is directed to the treatment of bacterial disorders such as impetigo, folliculitis and erythras- ma, by administering a topical composition comprising a benzoyl peroxide dispersion and clindamycin. [0013] US 2004/171561 A1 is directed to the treatment of rosacea, by administering a topical composition comprising a benzoyl peroxide dispersion and clindamycin. [0014] US 2004/151671 A1 is directed to foam compositions comprising an antibiotic (e.g. clindamycin) alone, or in 50 combination with other active ingredients such as a retinoid or benzoyl peroxide. [0015] US 2004/043946 A1 is directed to a topical composition for treating a skin disorder or condition, which comprises: a storage-stable mixture of a benzoyl peroxide dispersion, clindamycin or a pharmaceutically acceptable salt or ester thereof, and a pharmaceutically acceptable carrier. The composition has a final pH of about 4.5 to about 5, and the composition has a viscosity lower than the viscosity of the benzoyl peroxide dispersion before mixing. 55 [0016] WO 02/45662 A2 is directed to anhydrous creams, lotions and gels. [0017] The present subject matter provides a composition having a pharmaceutically active compound, which is useful for topical administration as described herein, as a foamable suspension gel that is non-runny, easy to apply, and does not leave a noticeable residue. The present foamable gel composition provides good control of the application of a small 2 EP 2 010 133 B1 amount of product to the desired area. SUMMARY OF THE INVENTION 5 [0018] The present subject matter provides a foamable suspension gel, comprising: benzoyl peroxide as the sole active ingredient that is sparingly soluble to insoluble in water, suspended in an aqueous phase; one or more thickening agents; and 10 an aerosol propellant; wherein the gel is aqueous, contains less than 1% by weight of oil and has a viscosity of 1000-20,000 centipoise at 25°C, and forms a homogeneous foam when dispensed from an aerosol container, and wherein the particle size of the active ingredient has an average diameter in the range of 0.5 to 100 mm. 15 [0019] In another aspect, the present subject matter provides for the use of an aqueous foamable suspension gel for the manufacturing of a medicament for use in treating a dermatological disease in a patient, preferably acne such as percutaneous treatment of acne. DETAILED DESCRIPTION OF THE INVENTION 20 Definitions [0020] Unless the context requires otherwise, the terms "active agent", "active compound," "at least one pharmaceu- tically active compound" and "pharmaceutically active agent" are used interchangeably herein and refer to a substance 25 having a pharmaceutical, pharmacological or therapeutic effect. [0021] As used herein, the terms "administering", "administration", and like terms refer to any method which, in sound medical or cosmetic practice, delivers the composition to a subject in such a manner as to provide a net positive effect. [0022] The term "dispersing agent" as used herein refers to a surface-active agent added to a suspending medium to promote uniform and maximum separation of extremely fine solid particles, often of colloidal size. See, Lewis, Hawley’s 30 Condensed Chemical Dictionary, 14th Edition, 2002. A dispersing agent can also be expressed in terms of its hydrophile- lipophile balance (HLB) number. Similarly, the term "wetting agent" as used herein refers to a surface-active agent that, when added to water, causes it to penetrate more easily into, or to spread over the surface of, another material by reducing the surface tension of the water.
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