CA2071146C - Taste preserving, mild oral hygiene compositions - Google Patents

Taste preserving, mild oral hygiene compositions

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Publication number
CA2071146C
CA2071146C CA002071146A CA2071146A CA2071146C CA 2071146 C CA2071146 C CA 2071146C CA 002071146 A CA002071146 A CA 002071146A CA 2071146 A CA2071146 A CA 2071146A CA 2071146 C CA2071146 C CA 2071146C
Authority
CA
Canada
Prior art keywords
weight
sulfosuccinate
oral hygiene
amount
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002071146A
Other languages
French (fr)
Other versions
CA2071146A1 (en
Inventor
Tiang-Shing Chang
Joseph Kanapka
Michael C. Alfano
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Block Drug Co Inc
Original Assignee
Block Drug Co Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Block Drug Co Inc filed Critical Block Drug Co Inc
Publication of CA2071146A1 publication Critical patent/CA2071146A1/en
Application granted granted Critical
Publication of CA2071146C publication Critical patent/CA2071146C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/55Phosphorus compounds
    • A61K8/553Phospholipids, e.g. lecithin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/02Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/0216Solid or semisolid forms
    • A61K8/022Powders; Compacted Powders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A61K8/466Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfonic acid derivatives; Salts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64Proteins; Peptides; Derivatives or degradation products thereof
    • A61K8/65Collagen; Gelatin; Keratin; Derivatives or degradation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/92Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/30Characterized by the absence of a particular group of ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/92Oral administration

Abstract

This invention relates to a mild oral hygiene composition such as a toothpaste, dental gel, mouthrinse or toothpowder containing a mild surfactant, protein fatty acid condensate or acid hydrolyzed, hydrolyzed animal protein or the mixtures thereof, and in combination therewith, mild high foaming surfactant, e.g., disodium cocoamido MIPA sulfosuccinate or disodium oleamido PEG-2 sulfosuccinate or disodium lauryl sulfosuccinate or the mixtures thereof; or a natural emulsifier, e.g., lecithin, or both a mild surfactant and a natural emulsifier.

Description

207114~

TASTE ~K~ iKVING, MILD ORAL HYGIENE COMPOSITIONS

The surfactant in dental hygiene products serves many purposes. T~ey are used for their detersive, emulsifying and antimicrobial properties in addition to their foaming character. Many consumers believe that high foam and rapid break-up indicate a superior cleaning ability.
The most commonly used surfactant in marketed dentifrices is sodium lauryl sulfate. It is readily available at low cost and generates a high foam. However, inclusion of this detergent in a dentifrice formulation requires the addition of high levels of costly flavor oils to mask the bitter taste of sodium lauryl sulfate itself.
Sodium lauryl sulfate also has been accused of generating a so called ~orange juice effect~. This effect may be detected as an unpleasant residual flavor note left in the mouth following the ingestion of orange juice after toothbrushin~ with a toothpaste containing the sodium lauryl sulfate. ~ndeed, in psychophysical evaluation of the effect of sodium lauryl sulfate on the taste of citric acid, it was determined that the surfactant added a distinctly bitter component to the usual sour taste of citric acid. In addition, it is also known that sodium lauryl sulfate and flavor oils are severe dermal irritants.
Therefore, it would be advantageous to replace sodium lauryl sulfate with a surfactant or a combination of surfactants, which possess a mild taste, a low dermal irritation potential and foaming properties comparable to the oral composition containing sodium lauryl sulfate. Furthermore, the flavor oils level for this 20~1t 4~

mild tasting dentifrice could be lowered significantly and thereby further reduce the dermal irritation potential of the oral composition and eliminate the so called "orange juice effect~.
It is an object of the present invention to provide a novel oral hygiene composition which overcomes at least one of the disadvantages of prior such oral compositions.
Accordingly, an oral hygiene composition which is free of sodium lauryl sulfate is provided comprising a protein derivative selected from the group consisting of protein fatty acid condensates and acid hydrolyzed animal proteins, together with at least one member of the group of (a) a flavor oil and a high foaming sulfosuccinate and (b) a natural emulsifier.
In accordance with this invention, imprsved oral hygiene compositions in the forms of dentifrice pastes, gels, powders and mouthrinses are pro~ided.
These compositions contain in an oral hygiene, e.g.
dental, vehicle, a protein deri~ative which may be a protein fatty acid condensate or an acid hydrolyzed animal protein, and at least one high foaming mild surfactant such as a sulfosuccinate and a natural emulsifier, e.g., lecithin. Suitably, the protein fatty acid condensate is potassium coco-hydrolyzed collagen or triethanolamine coco-hydrolyzed collagen acid and the acid hydrolyzed animal protein is collagen peptide; and the high foaming mild surfactant is suitably disodium oleamido PEG-2 sulfosuccinate, disodium cocoamido MIPA sulfosuccinate or disodium lauryl sulfosuccinate or mixtures thereof.
~ hen the comrosition does not contain lecithin, a flavor oil is incorporated. In 207~

compositions containing lecithin, a flavor oil may optionally be included. Lecithin, in addition to enhancing the dispersion of the flavor oil, improves the flavor impact in the oral environment.
The preferred compositions of this invention suitably comprise:
A) from about 0.01% to about 4.00% of a mild surfactant, a protein fatty acid co~encate having an average molecular weight from about 650 to about 900 or an acid hydrolyzed animal protein having an average molecular weight from about 500 to about 2000 or mixtures thereof;
B) from about 0.01% to about 1.5% of a high foaming mild surfactant, e.g.~ a sulfosuccinate.
C) from about 0.01% to about 5.00~ of a natural emulsifier, lecithin, to enhance the dispersion of the flavor oils in the dentifrice and to improve the flavor impact in the oral cavity;
D) from 0 to about 1.0%, preferably from about 0.01 to 1.0%, and most preferably, from 0.01 to 0.45% of a flavor oil.
All percentages given are percentages by weight of the fully compounded oral composition.
The compositions contemplated include toothpastes and dental gels wherein the preferred protein derivatives are potassium coco-hydrolyzed collagen, triethanolamine coco-hydrolyzed collagen and acid hydrolyzed collagen peptide, and the preferred high foaming sulfosuccinates are disodium oleamido PEG-2 sulfosuccinate and disodium cocoamido MIPH
sulfosuceinate; toothpowders wherein the preferred protein derivative is collagen peptide and the 207114~

preferred high foaming sulfosuccinate is disodium lauryl sulfosuccinate; and mouthrinses wherein the preferred protein derivative are potassium coco-hydrolyzed collagen and triethanolamine coco-hydrolyzed collagen. Also contemplated are toothpastes containing polyoxyethylene (40) stearate as a foam stabilizer.

The pre~erred mild oral hygiene compositions of this invention, such as toothpaste, dental gels, toothpowders, and mouthrinses comprise a mild surfactant system and a natural emulsifier, e.g., lecithin. The mild surfactant system contains at least one protein fatty acid co~encate or one acid hydrolyzed animal protein or mixtures thereof, from about 0.01% to about 4.0% by weight, optionally, in combination with a sulfosuccinate surfactant, from about 0.01% to about 1.5% by weight, to improve the foam density.
~ he protein fatty acid con~encates are considered to be anionic surfactants having an average molecular weight from about 650 to about 900 and having a general chemical formula:

H3C-(Cx2)lo-s-(NH-cH-~j4-ox R: Amino acid side chain of collagen X: Potassium, or triethanolamine The acid hydrolyzed animal proteins are considered to be cationic surfactants preferred as an acid hydrolyzed collagen having an average molecular 20711~

weight from about 500 to about 2000 and having a general chemical formula: ' H2N-~-C~-(NH ~CH ~~)n I S
R O R O R O
R: Amino acid side chain of collagen X: Hydrogen, sodium n- 8-11 The sulfosuccinate surfactants are disodium oleamido PEG-2 sulfosuccinate, disodium cocamido MIPA
su}fosuccinate and disodium lauryl sulfosuccinate having the general formula:

~H2 C~S03Na C02Na R: Fatty alcohol, ethoxylated fatty alcohol or fatty ~ nolamide The total amount of the mild surfactant system referred to above in the oral composition herein is from about 0.02% to about 5.50% by weight of the said oral composition, preferably, in the range of 0.5%
to 3.5%. When a sulfosuccinate surfactant is incorporated into the oral composition to increase the foam density, the ratio of the hydrolyzed animal protein and sulfosuccinate surfactant should be in the range of 0.01 to 20, preferably in the range of 0.1 to 15.

The emulsifier employed according to this invention as an optional component i'n dispersing flavor oils in the oral composition is preferably soybean lecithin, a natural emulsifier, having an approximate HL3 of 7 and a chemical formula:

C~I20COR

r~oCOR
CH2~-P~ -OCH2cH2N (CH3)3 R: Hydrogen or alkyl group The amount of lecithin referred to above in the oral composition is suitably from about 0.01% to about 5.00% by weight of the said oral composition, preferably, from about 0.10% to about 2.00%. --Other ingredients commonly used in typicaldentifrice compositions may include, but are not limited to, water, humectants, sweeteners, colors, opacifiers, abrasives, preservatives, thickeners and pharmacologically active ingredients such as water soluble fluoride, plaque and calculus inhibitors, antimicrobial agents, and dasensitizin~ compounds.
The sources of fluoride ions are well known in the art as anticaries agents. They are inorganic fluoride salts, such as sodium fluoride, stannous fluoride, sodium monofluorophosphate and the mixtures thereof. The amount of fluoride compounds, generally is from about 0.005% to about 3.00%, which releases from about 50 to about 3000 ppm of fluoride ion by weight of the oral composition.

2~71~

The liquid vehicle of the dentifrice pastes or gels may comprise water, humectants and thickening agents, in the amount from about 20.0% to about 90.0 by weight of the said composition. Examples of the suitable humectants are glycerine, sorbitol, yropylene glycol, polyethylene glycol and the mixtures thereof.
Examples of suitable thickening agents are modified cellulose products such as sodium carboxymethyl cellulose, hydroxyethyl cellulose, methyl cellulose, etc., and inorganic gel forming ingredients such as silica precipitates, colloidal magnesium aluminum carrageenan, alginates, etc. also are useful thickening agents.
The amount of the abrasive or polishiny agents in dentifrices is generally from about 15.0% to about 9~.0% by weight of the oral composition, preferably from about 15.0~ to about 80.0% in paste and gel and from about 65.0% to about 98.0% in toothpowder.
Examples of these materials are water-insoluble sodium metaphosphate, potassium metaphosphate, disbasic calcium phosphate anhydrous, dibasic calcium phosphate dihydrate, calcium carbonate, hydrated alumina, etc.
In clear gels, the preferred abrasive agents are colloidal silica and alkali metal alumino-silicate since they have refractive indices close to the refractive indices of the liquid gelling agents.
Typical flavor oils suitable for this invention include peppermint, spearmint, cinnamon, anethole, vanilla, lemon, orange and the like, at the levels from about 0.01% to about 1.0%. I~ is the particular feature of the invention that the flavor oil level for this mild tasting oral composition is 2 ~

significantly lower than the flavor levels in other typical oral c- ,~citions containing sodium lauryl sulfate.
In order to achieve cosmetically acceptable dentifrices gels and pastes, it is also useful to incorporate a colorant and a preservative.
The following examples further describe and provide preferred embodiments within the teachings of the invention and are solely for the purpose of illustration and are not to be considered as limitation of this invention.

EXAMPLES I - III
The following are dental gels of the present invention.
Weight (%) In~redient I II III
Water 12~5112.51 13.41 Glycerine 10.0010.00 10.00 Sorbitol (70%) 43.0043.00 43.00 Sodium carboxymethyl 0.90 0.90 0.90 celulose Sodium fluoride 0.24 0.24 0.24 Hydrated silica 30.0030.00 30.00 Potassium coco-hydrolyzed1.50 collagen (40%) Triethanolamine coco- 1.50 hydrolyzed collagen (40%) Collagen peptide 0.80 Disodium oleamido 0.20 PEG-2 sulfosuccinate Disodium cocoamido 0.20 MIPA sulfosuccinate Lecithin 0.40 0.40 0.40 Sodium saccharin 0.15 0.15 0.15 Methyl paraben 0.20 0.20 0.20 Dye solution (1.0%) 0.70 0.70 0.70 Flavor 0.20 0.20 0.20 2~7~

~XAMPLES IV - VI
The following are toothpastes representa-tive of the present invention.
Weight (%) Inqredient IV V VI
Water 24.85 24.90 24.85 Glycerine 16.00 16.00 16.00 Sorbitol (70%) 16.00 16.00 16.00 Natrosol 1.35 1.30 1.30 Sodium monofluorophosphate 0.80 0.80 0.80 Dicalcium phosphate anhydrous 7.00 7.00 7.00 Dicalcium phosphate 30.00 30.00 30.00 dihydrate 30.00 30.00 30.00 Aerosil 0.70 0.70 0.70 Potassium coco-hydrolyzed1.50 1.50 collayen (40%) Triethanolamine coco- 1.50 collagen peptide (40%) Disodium lauryl sulfo- 0.20 succinate Disodium oleamido 0.20 PEG-2 sulfosuccinate Disodium cocoamido 0.20 MIPA sulfosuccinate Lecithin 0.40 0.40 0.50 Sodium saccharin 0.20 0.20 0.15 Methyl paraben 0.20 0.20 0.20 Dye solution (1.0%) 0.60 0.60 0.60 Flavor 0.20 0.20 0.20 EXAMPLES VII- VIII
The following are toothpowders o~ the present invention.
Weight (~) Inqredient VII VIII
Sodium monofluorophosphate 0.80 0.80 Collagen peptide 1.00 0.80 Disodium lauryl sulfosuccinate 0.20 Hydrated silica 64.00 64.00 Dicalcium phosphate dihydrate 33.70 Calcium carbonate 33.65 Methyl paraben 0.15 0.15 Sodium saccharin 0.15 0.20 Flavor 0.20 0.20 ~7~

EXAMP~2S IX - X
The following are mouthrinses of the present invention.
Weight (%~
Inqredient IX X
Ethyl alcohol 5.00 7.00 Flavor 0.10 0.10 Glycerine 18.00 15.00 Potassium coco-hydrolyzed collagen0.50 Triethanolamine coca-hydrolyzed collagen 0.70 Lecithin 0.10 0.10 Sodium fluoride 0.02 0.02 Dye solution (1.0%) 0.10 0.10 Sodium benzoate 0.10 0.10 Water 76.03 76.88 EXAMPLES XI ~ XII
The ~ollowing are further e~amples of toothpastes of the present invention.
Weight (%) Inqredient XI XII
Water, deionized 27.89 to 27.49 42.59 to 43.09 Sodium fluoride 0.24 0.24 Methylparaben 0.12 0.12 Propylparaben 0.05 0.05 Sodium saccharin 0.30 0.20 Titanium dioxide 1.00 1.00 Polyoxyethylene (40) 2.00 2.00 stearate Fumed silica 0.60 1.20 Sorbitol 70% aqueous 12.00 12.00 solution Amorphous silica gel 26.00 14.00 Glycerin 25.00 10.00 Guar gum 0.40 0.40 Sodium carboxymethyl- 1.40 1.70 cellulose Potassium Coco- 2.00 1.50 hydrolyzed animal protein Flavor 0.60 to 1.00 0.2 to 0.7 Lecithin powder 0.30 0.30 Disodium lauryl 0.10 sulfosuccinate While certain representative embodiments and details have been shown for the pu~ose of illustrating the invention, it will be apparent to those skilled in the art that various changes may be made therein without departing from the spirit or scope of the invention.

Claims (10)

1. An oral hygiene composition which is free of sodium lauryl sulfate comprising:
a protein derivative selected from the group consisting of protein fatty acid condensates and acid hydrolyzed animal proteins, together with at least one member of the group of (a) a flavor oil with a high foaming sulfosuccinate, and (b) a natural emulsifier, wherein the protein derivative is present in an amount of about 0.01 to about 4.00% by weight, the high foaming sulfosuccinate is present in an amount of about 0.01 to about 1.50% by weight, the natural emulsifier is present in an amount of about 0.01 to about 5.00% by weight, and the flavor oil is present in an amount of about 0.01 to about 1.0% by weight.
2. An oral hygiene composition according to claim 1 which further contains from about 0.005% to about 3.00% by weight of a fluoride anticaries agent.
3. An oral hygiene composition according to claim 2, said composition being in the form of a toothpowder, wherein said protein derivative is collagen peptide and wherein said high foaming sulfosuccinate is disodium lauryl sulfosuccinate.
4. An oral hygiene composition according to claim 1 which contains both (a) and (b).
5. An oral hygiene composition according to claim 4 wherein said protein derivative is present in an amount of about 0.01 to 4.00% by weight, said high foaming sulfosuccinate is present in an amount of about 0.01 to 1.50% by weight, said natural emulsifier is lecithin, said lecithin being present in an amount of about 0.01 to 5.00% by weight, and said flavor oil is present in an amount of about 0.01% to 1.0% by weight and which further contains from about 0.005% to about 3.00%
by weight of a fluoride anticaries agent.
6. An oral hygiene composition according to claim 4, said composition being in the form of toothpaste or a dental gel, wherein said protein derivative is a member of the group consisting of potassium coco-hydrolyzed collagen, triethanolamine coco-hydrolyzed collagen, potassium coco-hydrolyzed animal protein and collagen peptide and gel, wherein said high foaming sulfosuccinate is selected from the group consisting of disodium oleamido PEG-2 sulfosuccinate and disodium cocoamido MIPA sulfosuccinate and wherein said natural emulsifier is lecithin.
7. An oral hygiene composition according to claim 1 in which the member of the group is (b) and wherein said protein derivative is present in an amount of about 0.01 to about 4.00% by weight, said natural emulsifier is lecithin, said lecithin being present in an amount of about 0.01 to about 5.00% by weight, the composition further containing from about 0.005 to about 3.00% by weight of a fluoride anticaries agent.
8. An oral hygiene composition according to claim 7 in the form of a toothpaste wherein said protein derivative is potassium coco-hydrolyzed animal protein and also comprising polyoxyethylene (40) stearate.
9. An oral hygiene composition according to claim 8 containing also a flavor oil in an amount of about 0.01 to 1.0% by weight.
10. An oral hygiene composition according to claim 9 in the form of a mouthrinse, wherein said protein derivative is selected from the group consisting of potassium coco-hydrolyzed collagen and triethanolamine coco-hydrolyzed collagen.
CA002071146A 1991-06-12 1992-06-12 Taste preserving, mild oral hygiene compositions Expired - Lifetime CA2071146C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/713,512 US5120528A (en) 1991-06-12 1991-06-12 Taste preserving, mild oral hygiene compositions
US07/713,512 1991-06-12

Publications (2)

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CA2071146A1 CA2071146A1 (en) 1992-12-13
CA2071146C true CA2071146C (en) 1999-06-08

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Country Status (10)

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US (1) US5120528A (en)
EP (1) EP0518608B1 (en)
JP (1) JP2922362B2 (en)
KR (1) KR0169139B1 (en)
CN (1) CN1043185C (en)
AT (1) ATE119765T1 (en)
CA (1) CA2071146C (en)
DE (1) DE69201677T2 (en)
DK (1) DK0518608T3 (en)
ES (1) ES2069380T3 (en)

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DK0518608T3 (en) 1995-05-29
US5120528A (en) 1992-06-09
CA2071146A1 (en) 1992-12-13
KR0169139B1 (en) 1999-01-15
CN1043185C (en) 1999-05-05
ES2069380T3 (en) 1995-05-01
EP0518608B1 (en) 1995-03-15
EP0518608A1 (en) 1992-12-16
JPH05170632A (en) 1993-07-09
JP2922362B2 (en) 1999-07-19
KR930000103A (en) 1993-01-15
AU648173B2 (en) 1994-04-14
AU1730892A (en) 1992-12-17
ATE119765T1 (en) 1995-04-15
DE69201677D1 (en) 1995-04-20
CN1067576A (en) 1993-01-06
DE69201677T2 (en) 1995-07-13

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