Topically applicable anti-inflammatory O/W emulsions comprising pro-penetrating glycols

a technology of pro-penetrating glycol and o/w emulsion, which is applied in the direction of biocide, dermatological disorders, drug compositions, etc., can solve the problem of thick cream of waxy appearan

Inactive Publication Date: 2007-11-15
GALDERMA SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the stabilization of a formulation comprising such a percentage of glycol makes it necessary to include in the emulsion emulsifiers and stabilizers of glyceryl stearate or PEG 100 stearate type or, alternatively, stabilizers or consistency factors of white wax or cetostearyl alcohol type, which lead to the formation of a thick cream of waxy appearance.

Method used

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  • Topically applicable anti-inflammatory O/W emulsions comprising pro-penetrating glycols

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0080]

Waterqs 100ammonium acryloyldimethyltaurate /  1.00%VP copolymerclobetasol propionate 0.05%propylene glycol37.50%dimethyl isosorbide10.00%liquid paraffin20.00%PEG-6 isostearate 2.00%sodium hydroxideqs pH 6

[0081] Physical and chemical stability of the composition of Example 1:

T0 = thick white milkpH = 7.54Centrifuge: 10 000 rpm: nocommentsMicro: globule size T1 monthRTMacroscopicThick white milk, inappearanceaccordance with T0pHpH 7.6Microscopic appearanceGlobule size 2.5 μm,homogeneous carpetAssay of the active97.9%agent (HPLC)T0: 99% 4° C.MacroscopicThick white milk, inappearanceaccordance with T0Microscopic appearanceGlobule size 2.5 μm,homogeneous carpetNo recrystallization of theclobetasolMacroscopicThick white milk, inappearanceaccordance with T040° C.Assay of the active96.3%agent (HPLC)T0: 99%

example 2

[0082]

Waterqs 100ammonium acryloyldimethyltaurate / 1.00%VP copolymerclobetasol propionate0.05%propylene glycol42.50% ethanol5.00%liquid paraffin20.00% PEG-6 isostearate2.00%sodium hydroxideqs pH 6

[0083]

T0 = thick white milkpH = 6.7Centrifuge: 10 000 rpm: nocommentsMicro: globule size T1 monthRTMacroscopicThick white milk, inappearanceaccordance with T0pHpH 6.7Microscopic appearanceGlobule size from 2.5 μmand 7.5 μm,heterogeneous carpetAssay of the active98.1%agent (HPLC)T0: 99.7% 4° C.MacroscopicThick white milk, inappearanceaccordance with T0Microscopic appearanceGlobule size from 2.5 μmand 7.5 μm,heterogeneous carpetNo recrystallization of theclobetasol40° C.MacroscopicThick white milk, inappearanceaccordance with T0Assay of the active97.4%agent (HPLC)T0: 99.7%

example 3

[0084]

Waterqs 100acrylates / steareth-203.50%methacrylate copolymerclobetasol propionate0.05%propylene glycol45.00% diethylene glycol monoethyl ether1.50%propylene glycol laurate1.00%liquid paraffin20.00% polyglyceryl-3 diisostearate2.00%sodium hydroxideqs pH 6

[0085]

T0 = thick white milkpH = 6.33Centrifuge: 10 000 rpm: slightphase separationMicro: globule size T1 monthRTMacroscopicThick white milk, inappearanceaccordance with T0pHpH 6.36Microscopic appearanceGlobule size homogeneous carpetAssay of the active98.3%agent (HPLC)T0: 99.6% 4° C.MacroscopicThick white milk, inappearanceaccordance with T0Microscopic appearanceGlobule size homogeneous carpetNo recrystallization of theclobetasol40° C.MacroscopicThick white milk, inappearanceaccordance with T0Assay of the active97.6%agent (HPLC)T0: 99.6%

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Abstract

Stable, topically applicable, non-greasy and non-tacky oil-in-water (O / W) anti-inflammatory emulsions, useful, e.g., for the treatment of psoriasis, contain: a. a therapeutically effective amount of at least one steroidal anti-inflammatory agent, notably clobetasol propionate; b. a pro-penetrating system which includes at least one pro-penetrating glycol and at least one other pro-penetrating agent; and c. at least one polymeric emulsifier not sensitive to electrolytes, for example not an acrylate / C10-C30 alkyl acrylate copolymer, formulated into a topically applicable, pharmaceutically acceptable vehicle therefor.

Description

CROSS-REFERENCE TO PRIORITY APPLICATION [0001] This application claims priority under 35 U.S.C. § 119 of FR 06 / 02283, filed Mar. 15, 2006, hereby expressly incorporated by reference and assigned to the assignee hereof. CROSS-REFERENCE TO COMPANION APPLICATION [0002] Copending application Ser. No. ______ [Attorney Docket No.1034227-000106], filed concurrently herewith and also assigned to the assignee hereof.BACKGROUND OF THE INVENTION [0003] 1. Technical Field of the Invention [0004] The present invention relates to novel compositions in the form of emulsions of oil-in-water (O / W) type for topical application, comprising a novel combination of pro-penetrating agents including at least one glycol, a suitable emulsifying system and a bioactive agent of the family of steroidal anti-inflammatory agents. [0005] 2. Description of Background and / or Related and / or Prior Art [0006] There currently exist many topical compositions comprising a steroidal anti-inflammatory agent and a high conte...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/107A61K47/14A61P17/06
CPCA61K9/0014A61K31/573A61K47/10A61K47/34A61K47/22A61K47/26A61K47/32A61K47/12A61P17/06
Inventor SEGURA-ORSONI, SANDRINEROUMEC, SOPHIE
Owner GALDERMA SA
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