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Water-based delivery systems

a delivery system and water-based technology, applied in the field of new products, can solve the problems of stratum corneum losing its natural ability to function properly as a barrier, skin becoming either too dry or too permeable to environmental substances, and achieve the effect of enhancing skin barrier restoration

Inactive Publication Date: 2009-03-26
GALDERMA LAB LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The detergent properties can lead to disruption of the normal barrier function, which is counteractive to the potential benefit of the delivery system.
Disruption of the normal barrier function often causes the stratum corneum to lose its natural potential to function properly as a barrier.
As a result, the skin becomes either too dry or too permeable to environmental substances.
Due to the impermeability, though, these ointments both increase the body temperature of the treated body part, as well as prevent perspiration, and thus render an uncomfortable sensation.
The dermal delivery systems described above are not formulated to deliver a substance to, or through, the human skin without permanently disrupting the stratum corneum's natural barrier function.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

A General Method of Making

[0154]The phospholipid, cholesterol, palmitic acid and ceramide components are mixed together with water, and agitated at a temperature of 70-80° C. The following additional components are added: mevalonic acid lactone, 25-hydroxycholecalciferol, propylene glycol, glycerine, PVP, TEA added along with water, and sodium hydroxide. Sodium hydroxide is added to adjust viscosity and stabilize the formulation. Water is then added, and the formulation is agitated well. The formulation is then cooled down.

[0155]An active substance can be dissolved in both the lipid phase and / or the water phase, depending on the solubility and concentration of the active substance.

example 2

Formulation of a Preferred Embodiment of the Topical Delivery System

[0156](An active ingredient is excluded from this formulation.)

ComponentTotal amountWater79.5% of formulation Epikuron 200SH3.5% of formulationPalmitic acid1.5% of formulationCholesterol1.5% of formulationMevalonic acid0.01% of formulation Triethanolamine0.5% of formulationPhenonip0.4% of formulationXanthan gum2.0% of formulationSkinflux2.0% of formulation25-hydroxycholecalciferol0.0015% of formulation  Propylene glycol4.0% of formulationGlycerol3.0% of formulationPolyvinylpyrrolidone2.0% of formulationEpikuron 200SH are hydrogenated lecithins, i.e. phosphatidylcholine (PC).“Skinflux” is a blend product obtainable from Degussa Goldschmidt which contains: Ceramide 1, 3, 6II; Phytosphingosine; Cholesterol; Sodium Lauroyl Lactylate; Carbomer; and Xanthan Gum.Mevalonic acid lactone is a lipid precursor for cholesterol / fatty acids.25-Hydroxycholecalciferol is a lipid precursor for ceramidesXanthan Gum is a thickener (pol...

example 3

Formulation with Lidocaine as an Active Ingredient

[0166]An example of a 48 kg batch of a formulation of the delivery system follows. The three fractions used to prepare this formulation each contain 16 kg.

INCI NameTrade NameSupplierCASAmountHydrogenatedEpikuron 200 SHDegussa1.7 kgLecithinesGoldschmidtCholesterolVendico57-88-50.8 kgPalmitic acidKarlshamn57-10-30.8 kgCeramide 1, 3, 6II,Skin FluxDegussa1.0 kgPhytosphingosine,GoldschmidtCholesterol,Sodium LauroylLactylate,Carbomer, XanthanGum.Mevalonic acidSigma Aldrich674-26-04.8 g lactone25-Hydroxy-Solvay19356-17-30.72 kg cholecalciferolPropylene glycolMB-Sveda57-55-62.0 kgGlycerin, 99.5%Vendico56-81-51.5 kgPolyvinylpyrrolidoneApoteket9003-39-81.0 kgXanthan gumSigma Aldrich11138-66-21.0 kgTriethanolamine,MB-Sveda102-71-60.3 kg85%PhenonipVendico0.2 kgChemicalLidocainUSP-gradeApoteket2.4 kgPurifiedUp toWater 48 kg

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Abstract

The invention relates to a water-based delivery system for an active substance, characterized by enhancing skin barrier restoration in the stratum corneum comprising water, a fatty acid, cholesterol, a ceramide and at least one skin lipid precursor.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of U.S. Provisional Application No. 60 / 365,059, filed Mar. 13, 2002, which is incorporated herein by reference.FIELD OF THE INVENTION[0002]The present invention relates to a novel topical and mucosal delivery systems for drugs or any other active substance.BACKGROUND OF THE INVENTION[0003]The main demands on human skin are to prevent loss of water, and to prevent water and other matter of the environment from entering the body indiscriminately. The human skin thus forms a selectively permissible physical barrier between the human body and its surroundings.[0004]The barrier function has been shown to reside in the stratum corneum. The stratum corneum is the topmost layer of the skin, and is built of corneocytes. Corneocytes are cells that contain extensively cross-linked proteins, surrounded by a highly resistant cell envelope. The corneocytes are embedded in a bed of specific lipid structures of long cha...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K47/12A61K38/02A61K8/00A61K39/00A61K38/21A61K31/437A61P17/00A61K47/28A61K8/42A61K8/55A61K8/63A61K8/68A61K9/00A61K9/08A61K9/127A61K45/00A61K47/00A61K47/08A61K47/10A61K47/14A61K47/18A61K47/20A61K47/22A61K47/24A61K47/26A61K47/44A61Q17/00A61Q19/00
CPCA61K8/42A61K8/553A61K8/63A61K8/68A61K9/0014A61K9/1272A61K47/12A61K47/18A61K47/24A61K47/28A61Q17/00A61Q19/00A61P17/00A61K9/00A61K9/06
Inventor SKOLD, THOMAS
Owner GALDERMA LAB LP
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