WO2002005789A2 - Lösung, dispersion oder emulsion bildende folien-dermatika - Google Patents
Lösung, dispersion oder emulsion bildende folien-dermatika Download PDFInfo
- Publication number
- WO2002005789A2 WO2002005789A2 PCT/EP2001/007504 EP0107504W WO0205789A2 WO 2002005789 A2 WO2002005789 A2 WO 2002005789A2 EP 0107504 W EP0107504 W EP 0107504W WO 0205789 A2 WO0205789 A2 WO 0205789A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- dosage form
- film
- form according
- skin
- emulsion
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0208—Tissues; Wipes; Patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
Definitions
- the invention relates to film-like administration forms for delivering pharmaceutical or cosmetic active ingredients to the skin, preferably to human skin.
- Active ingredients for the care of the skin, for the treatment of skin diseases or subcutaneous diseases such as Rheumatism is usually administered with the help of solutions, lotions, powders, sprays or semi-solid preparations such as ointments, creams or gels.
- Dosage forms of this kind are generally provided in a multi-axis withdrawal container such as a tube or crucible.
- a container contains a quantity of the dosage form which is intended for a large number of applications with corresponding dose processes.
- the dosing itself is done individually by the user. The user can only make statements about the dosed amount of active ingredient if he weighs the respective dose before use. With repeated use, the reproducible application of a constant amount of active ingredient would only be possible with the help of an upstream weighing process.
- This individually variable dosage is only possible due to the low coherence and easy division of these forms.
- the low coherence offers the advantage that the shape, as mentioned, can be deformed as desired and can be adapted to uneven surfaces.
- Such dosage forms can be formulated without preservatives and allow an exact and reproducible dosage of active ingredients. It is disadvantageous that the dosage forms are not soluble and therefore distributable, that the area to be treated is predetermined by the dimensions of the dosage form and that e.g. complex emulsion systems cannot be applied with the help of such dosage forms. It is therefore an object of the present invention to find an individually packable dosage form for delivering a defined single dose of active ingredients to the skin, which avoids the disadvantages of the dosage forms according to the prior art.
- the solution was found in a flexible active substance-containing film, which forms a spreadable solution, dispersion or emulsion on the skin in contact with skin moisture and / or sweat and immediately releases a single dose of the active substance or several active substances.
- the dosage form because it is in the form of a dried film, can be formulated without preservatives and has the property that a defined amount of active ingredient can be applied as often and reproducibly as desired and distributed over the desired application area.
- the film consists of 1-60% of at least one film former which is soluble in polar solvents, preferably water or polar organic solvents such as ethanol, isopropanol or ethyl acetate or mixtures thereof, 1-60% of at least one water-soluble gel former 1-60 % of at least one plasticizer and 0.1-40% of at least one active ingredient and optionally further Excipients.
- polar solvents preferably water or polar organic solvents such as ethanol, isopropanol or ethyl acetate or mixtures thereof
- water-soluble gel former 1-60 % of at least one plasticizer
- 0.1-40% of at least one active ingredient and optionally further Excipients.
- the film consists of 5-50% by weight of at least one film former which is soluble in polar solvents, 1-50% by weight of at least one gel former, 0.5-50% by weight of at least one plasticizer, 5-40 wt .-% of at least one active ingredient and optionally other auxiliaries.
- the type and amount of the film former determine the strength and durability of the film when dry.
- a flowable solution, dispersion or emulsion must first be formulated, from which the solvent or dispersion medium is removed by spreading and drying.
- easily removable solvents such as water, ethanol, isopropanol, ethyl acetate or mixtures thereof are preferably used to produce the base material.
- Suitable polymeric film formers which are soluble in the polar organic solvents mentioned are preferably found among the polyvinylpyrrolidones, the polyvinyl alcohols, the polyacrylic acids and polymethacrylic acids, the celluloses, their derivatives and combinations thereof.
- the film contains one or more water-soluble gelling agents that ensure that the Film swells and disintegrates spontaneously on contact with moisture.
- the consistency of the spontaneously emerging dosage form, from which active substance is released to the skin immediately after formation, depends directly on the type and concentration of the gel former used and the amount of water or aqueous solution available, such as sweat. For example, both an aqueous solution and a hydrogel can be formed from a given film formulation become.
- Suitable water-soluble gelling agents are preferably natural or semi-synthetic polymers from the group of plant polysaccharides such as alginates, pectins, carrageenans, tragacanth, or xanthan gum, cellulose derivatives such as methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose or sodium carboxymethylcellulose, starch and starch derivatives, galactomannan and galactomannan derivatives, chitosan and chitosan derivatives and their combinations.
- plant polysaccharides such as alginates, pectins, carrageenans, tragacanth, or xanthan gum
- cellulose derivatives such as methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose or sodium carboxymethylcellulose
- starch and starch derivatives galactomannan and galactomannan derivatives, chitosan and
- the film-like dosage forms according to the invention must not be rigid and brittle, since otherwise the application on an uneven surface such as the skin would be considerably more difficult for the user.
- the film contains a plasticizer such as glycerin, sorbitol, mannitol, low molecular weight polyethylene glycols and polypropylene glycols, citric acid esters such as triethyl citrate or acetyl triethyl citrate, Weinchu- esters such as dibutyl tartrate, Glycerinester as glycerol diacetate or glycerol triacetate, Phthal Acid esters such as dibutyl phthalate or diethyl phthalate, and / or hydrophilic surfactants, preferably hydrophilic, non-ionic surfactants, such as, for example, partial fatty acid esters of sugars, polyethylene glycol fatty acid esters, polyethylene glycol fatty alcohol ethers or polyethylene glycol sorbitan fatty
- the dosage form according to the invention for delivering active substances to the skin can contain pharmaceutical active substances for dermal treatment of local skin diseases or for intradermal treatment of diseases, as well as cosmetic active substances for skin care or for influencing skin conditions.
- Local anesthetics, local antibiotics, antiseptics, antifungals, antihistamines and antipruritic drugs, keratolytics and caustic drugs, antivirals, anti-cabbage drugs, steroids, as well as various substances for the treatment of acne, psoriasis or light dermatoses are used for the dermal treatment of local skin diseases.
- the active substances which are administered intradermally according to the invention include steroidal and non-steroidal anti-inflammatory drugs, local anesthetics, substances which promote blood circulation, vasoprotectors or -constrictors for the treatment of vascular diseases as well as active substances for influencing processes in the subcutaneous fatty tissue.
- the dosage form according to the invention can, for example, actives for the treatment of wrinkles, aged skin, blemished skin, pimples, skin rashes, for skin lightening, for moisturizing the skin, for regeneration and revitalization, for skin tightening, for light protection, for reducing perspiration, for neutralizing odors and - Overlay, for hair removal, for cleaning and body care as well as volatile substances for protection against, for example Mosquitoes, wasps or ticks included.
- an OW emulsion is first prepared in a conventional manner known to those skilled in the art, from which a film containing an inner phase, which is distributed in small droplets, is formed by spreading and drying. After the film has dried, the inner lipophilic phase is immobilized by the polymer network of the hydrophilic outer phase in such a way that the tendency to phase separation when the film is stored is very slight.
- the dosage form according to the invention has the advantage that the use of emulsion-stabilizing auxiliaries can be significantly reduced.
- the lipophilic phase can be made from natural, semi-synthetic or synthetic fats and oils such as olive oil, castor oil, peanut oil, soybean oil, linseed oil, sesame oil, jojoba oil, avocado oil, hydrogenated peanut oil, hydrogenated castor oil, triglyceride mixtures (Miglyol®, Softisan®) or silicone oils, natural , semi-synthetic or synthetic waxes such as beeswax, wool wax, earth wax, walrate, oleic acid oleylester, isopropyl palmitate, isopropyl myristate, ethyl oleate, cetyl palmitate or cetyl stearate, fatty alcohols such as dodecyl alcohol!
- natural, semi-synthetic or synthetic fats and oils such as olive oil, castor oil, peanut oil, soybean oil, linseed oil, sesame oil, jojoba oil, avocado oil, hydrogenated peanut oil, hydrogenated
- the dosage form according to the invention for dispensing active ingredients can contain:
- Penetration accelerators such as alkyl sulfates, alkyl sulfonates, alkali soaps, fatty acid salts of polyvalent metals, betaines, amine oxides, fatty acids, fatty acid esters, mono-, di- or triglycerides, long-chain alcohols, sulfoxides, nicotinic acid esters, salicylic acid, N-methylpyrrolidone or 2-pyrrolidone, 2-pyrrolidone, 2-pyrrolidone • Preservatives such as p-C1-m-cresol, phenylethyl alcohol, phenoxyethyl alcohol, chlorobutanol, methyl 4-hydroxybenzoate, propyl 4-hydroxibenzoate, benzalkonium chloride, cetylpyridinium chloride, chlorhexidine diacetate or gluconate, ethanol or propylene glycol
- pH regulators such as glycerol buffer, citrate buffer, borate buffer, phosphate buffer or citric acid-phosphate buffer
- Antioxidants such as ascorbic acid, ascorbyl palmitate, tocopherol acetate, propyl gallate, butylated hydroxyanisole or butylated hydroxitoluole
- Emulsion stabilizers such as non-ionic emulsifiers, amphoteric emulsifiers, cation-active emulsifiers and anion-active emulsifiers.
- a low-viscosity, flowable mass for example a solution, a dispersion or an emulsion, which contains the active ingredient in homogeneously distributed form, is first prepared.
- This mass is then used to coat a flat, dehesively finished substrate by a process known to the person skilled in the art.
- the solidification takes place after the coating of the flat substrate by removing the solvent or dispersion medium by means of drying.
- the build-up of cohesive forces depends on the polymer structure of the film formed from the film former and gel former. The result is a wide, film-like endless belt with a through the coating predetermined thickness.
- the limiting factor for the thickness of the tape in a given formulation is the requirement for flexibility and deformability of the individual, divided dosage form to adapt to the skin surface.
- Individual dosage forms with a predetermined area are separated from the endless belt using known methods, such as punching and cutting. After the foils have been separated, they can be packed individually in small bags or several in appropriate foil dispensing systems. Since the coating is carried out with a mass that contains the active ingredient in a homogeneously distributed form, while maintaining a constant coating weight, all individually separated dosage forms contain the same amount of active ingredient in a homogeneous distribution. This allows the user an exact and reproducible dosage.
- the dosage form according to the invention offers the possibility of metering even very small amounts of active ingredient precisely and reliably.
- the film is produced from solution, dispersion and / or emulsion by metering into films provided with cups (for example deep-drawn blisters) and then drying.
- the invention therefore encompasses dosage forms of the type described above, in which the active substance-containing film can be obtained from solution, dispersion and / or emulsion by metering into films provided with cups (for example deep-drawn blisters) and then drying.
- the packaging of the dosage form according to the invention in small bags or film dispensers offers the user the advantage that such packaging units can be accommodated in clothing and bags in a simple and space-saving manner.
- dosage forms in multiple withdrawal containers such as tubes and jars
- neither microbial contamination nor loss of active substance through frequent opening and closing can take place in the single-metered film according to the invention.
- Possible formulations and methods for producing the film according to the invention for delivering active substances to the skin in accordance with the features of the main claim are explained below by way of example, without the invention being restricted thereto.
- the dispersion is spread with a line width of 400 ⁇ m on a siliconized paper and convectively in a drying tunnel at 60 ° C and an air speed of approx. 5 m / sec. dried. After drying, a soft, deformable film is obtained which has a basis weight of 100 g / m 2 . Rectangular film sections of 30 cm 2 area are cut out of the dried web. After application to the skin and moistening with water, a hydrogel spontaneously forms, which after rubbing in at the application site has a local anesthetic effect, which is necessary, for example, in the treatment of tennis elbow pain.
- Oval film sections with an area of 16 cm 2 are punched out of the dried web. After application to the skin and moistening with water, a hydrogel spontaneously forms, which is used for the local treatment of sunburn and other first-degree burns, blunt injuries and poorly healing superficial wounds.
- 2 g of polyacrylic acid (Carbopol 940) and 4 g of ethyl cellulose (ethyl cellulose N 50 NF) are dissolved in a mixture of 60 g of ethanol and 10 g of water with uniform stirring. Then 2 g sodium alginate (Manucol LB), 3 g tapioca starch (Tapioca pure 28-180), 5 g glycerin, 5 g polyethylene glycol 400, 4 g amica tincture and 5 g marigold tincture are stirred in until an even distribution is achieved is.
- the dispersion is spread with a line width of 350 ⁇ m on a siliconized paper and convectively in a drying tunnel at 60 ° C and an air speed of approx. 5 m / sec. dried. After drying, a soft, deformable film is obtained which has a weight per unit area of 105 g / m 2 .
- Rectangular film sections with an area of 25 cm 2 are cut out of the dried web. After application to the skin and moistening with water, a hydrogel spontaneously forms, which can be used for the intradermal treatment of sprains, bruises and bruises.
- Example 4
- the dispersion is spread with a line width of 360 ⁇ m on a siliconized paper and convectively in a drying tunnel at 60 ° C and an air speed of approx. 5 m / sec. dried. After drying, a soft, deformable film is obtained which has a weight per unit area of 120 g / m 2 .
- Round film sections with an area of 10 cm 2 are punched out of the dried web. After applying it to the skin and moistening it with water, a hydrogel is created that has a drying, keratolytic and anti-inflammatory effect and can therefore be used to treat acne.
- the dispersion is spread with a line width of 250 ⁇ m on a siliconized paper and convectively in a drying tunnel at 70 ° C and an air speed of approx. 8 m / sec. dried. After drying, a soft, deformable film is obtained which has a basis weight of 80 g / m 2 . Rectangular film sections with an area of 10 cm 2 are cut out of the dried web. If there is sweat, the film sections are applied, for example, to the armpits. They dissolve spontaneously and have an antiperspirant and odor-neutralizing effect.
- phase B 8 g of soybean oil, 2 g of polyethylene glycol monostearate, 4 g of cetylstearyl alcohol, 2 g of tocopherol acetate and 0.1 g of retinyl palmitate are mixed and slowly stirred with warming until the solution is clear (phase B).
- Phase A is incorporated in portions into phase B at 65 ° C. with stirring and homogenization.
- the emulsion is spread on a siliconized paper at a temperature of 65 ° C with a line width of 250 ⁇ m and convectively in a drying tunnel at 70 ° C and an air speed of approx. 8 m / sec. dried. After drying, a soft, deformable film is obtained which has a weight per unit area of 120 g / m 2 .
- Oval film sections of 20 cm 2 are punched out of the dried web. After applying it to the skin and moistening it with water, an oil-in-water emulsion is created, which can be used as a night cream, for example, by giving vitamins to regenerate and revitalize the skin.
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Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002416383A CA2416383C (en) | 2000-07-15 | 2001-06-30 | Solution-, dispersion- or emulsion-producing film dermatics |
AU2001283909A AU2001283909B2 (en) | 2000-07-15 | 2001-06-30 | Solution-, Dispersion-or emulsion-producing film dermatics |
US10/333,027 US20040009211A1 (en) | 2000-07-15 | 2001-06-30 | Film-dermatics |
EP01962806A EP1301180A2 (de) | 2000-07-15 | 2001-06-30 | Lösung, dispersion oder emulsion bildende folien-dermatika |
AU8390901A AU8390901A (en) | 2000-07-15 | 2001-06-30 | Film dermatics |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10034491.7 | 2000-07-15 | ||
DE10034491A DE10034491A1 (de) | 2000-07-15 | 2000-07-15 | Folien-Dermatika |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002005789A2 true WO2002005789A2 (de) | 2002-01-24 |
WO2002005789A3 WO2002005789A3 (de) | 2002-05-10 |
Family
ID=7649068
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2001/007504 WO2002005789A2 (de) | 2000-07-15 | 2001-06-30 | Lösung, dispersion oder emulsion bildende folien-dermatika |
Country Status (7)
Country | Link |
---|---|
US (1) | US20040009211A1 (de) |
EP (1) | EP1301180A2 (de) |
AR (1) | AR029716A1 (de) |
AU (2) | AU8390901A (de) |
CA (1) | CA2416383C (de) |
DE (1) | DE10034491A1 (de) |
WO (1) | WO2002005789A2 (de) |
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EP1317916A3 (de) * | 2001-11-16 | 2003-07-16 | National Starch and Chemical Investment Holding Corporation | Filme enthaltend modifizierte Stärke |
FR2858226A1 (fr) * | 2003-07-29 | 2005-02-04 | Oreal | Procede de traitement a partir d'une feuille dont une face comporte une couche d'un produit capable de transferer au moins partiellement sur la surface a traiter |
WO2005034887A1 (en) * | 2003-09-11 | 2005-04-21 | Kimberly-Clark Worldwide, Inc. | Lotioned tissue product with improved stability |
WO2005060932A1 (en) * | 2003-12-12 | 2005-07-07 | Kimberly-Clark Worldwide, Inc. | Tissue products comprising a cleansing composition |
WO2005070376A2 (de) * | 2004-01-21 | 2005-08-04 | Wella Ag | Haarstylingfolien und verfahren zur herstellung haarfestigender produkte in folienform |
FR2868949A1 (fr) * | 2004-04-19 | 2005-10-21 | Oreal | Kit de formulation d'un produit cosmetique |
FR2871685A1 (fr) * | 2004-06-22 | 2005-12-23 | Oreal | Procede de rasage avec un film anhydre ; utilisation d'un film anhydre pour la preparation d'un produit de rasage ; kits de rasage |
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EP1671613A1 (de) | 2004-12-07 | 2006-06-21 | L'oreal | Transungual system |
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US7547443B2 (en) | 2003-09-11 | 2009-06-16 | Kimberly-Clark Worldwide, Inc. | Skin care topical ointment |
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US7811953B2 (en) | 2005-12-07 | 2010-10-12 | L'oreal | Soluble patch |
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JPH10151715A (ja) * | 1996-11-22 | 1998-06-09 | Dainippon Ink & Chem Inc | 熱融着可能な乳酸系ポリマー積層体 |
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2000
- 2000-07-15 DE DE10034491A patent/DE10034491A1/de not_active Ceased
-
2001
- 2001-06-30 CA CA002416383A patent/CA2416383C/en not_active Expired - Fee Related
- 2001-06-30 EP EP01962806A patent/EP1301180A2/de not_active Withdrawn
- 2001-06-30 AU AU8390901A patent/AU8390901A/xx active Pending
- 2001-06-30 US US10/333,027 patent/US20040009211A1/en not_active Abandoned
- 2001-06-30 AU AU2001283909A patent/AU2001283909B2/en not_active Ceased
- 2001-06-30 WO PCT/EP2001/007504 patent/WO2002005789A2/de active Application Filing
- 2001-07-13 AR ARP010103332A patent/AR029716A1/es unknown
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US9108340B2 (en) | 2001-10-12 | 2015-08-18 | Monosol Rx, Llc | Process for manufacturing a resulting multi-layer pharmaceutical film |
US9931305B2 (en) | 2001-10-12 | 2018-04-03 | Monosol Rx, Llc | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
US10285910B2 (en) | 2001-10-12 | 2019-05-14 | Aquestive Therapeutics, Inc. | Sublingual and buccal film compositions |
US8906277B2 (en) | 2001-10-12 | 2014-12-09 | Monosol Rx, Llc | Process for manufacturing a resulting pharmaceutical film |
US8900498B2 (en) | 2001-10-12 | 2014-12-02 | Monosol Rx, Llc | Process for manufacturing a resulting multi-layer pharmaceutical film |
US8900497B2 (en) | 2001-10-12 | 2014-12-02 | Monosol Rx, Llc | Process for making a film having a substantially uniform distribution of components |
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US8652378B1 (en) | 2001-10-12 | 2014-02-18 | Monosol Rx Llc | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
US9855221B2 (en) | 2001-10-12 | 2018-01-02 | Monosol Rx, Llc | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
US11077068B2 (en) | 2001-10-12 | 2021-08-03 | Aquestive Therapeutics, Inc. | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
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FR2858226A1 (fr) * | 2003-07-29 | 2005-02-04 | Oreal | Procede de traitement a partir d'une feuille dont une face comporte une couche d'un produit capable de transferer au moins partiellement sur la surface a traiter |
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US7485373B2 (en) | 2003-09-11 | 2009-02-03 | Kimberly-Clark Worldwide, Inc. | Lotioned tissue product with improved stability |
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KR101158227B1 (ko) * | 2003-12-12 | 2012-06-20 | 킴벌리-클라크 월드와이드, 인크. | 세정 조성물을 포함하는 티슈 제품 |
KR101077022B1 (ko) * | 2003-12-12 | 2011-10-26 | 킴벌리-클라크 월드와이드, 인크. | 세정 조성물을 포함하는 티슈 제품 |
US7332179B2 (en) | 2003-12-12 | 2008-02-19 | Kimberly-Clark Worldwide, Inc. | Tissue products comprising a cleansing composition |
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FR2868949A1 (fr) * | 2004-04-19 | 2005-10-21 | Oreal | Kit de formulation d'un produit cosmetique |
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Also Published As
Publication number | Publication date |
---|---|
EP1301180A2 (de) | 2003-04-16 |
AU2001283909B2 (en) | 2006-12-21 |
DE10034491A1 (de) | 2002-01-24 |
AR029716A1 (es) | 2003-07-10 |
AU8390901A (en) | 2002-01-30 |
WO2002005789A3 (de) | 2002-05-10 |
CA2416383C (en) | 2009-08-18 |
CA2416383A1 (en) | 2002-01-24 |
US20040009211A1 (en) | 2004-01-15 |
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