AU598512B2 - Stabilized dental cream - Google Patents

Description

LFI~ I COMMONWEALTH OF AUSTRALIA- Patent Act 1952 5 9 8 5 1 2 P O M P T T E S P E C I F ICATION

(ORIGINAL)

Class Int. Class Application Number 7 O- 0 ,7 Lodged Complete Specification Lodged Accepted This docunmnt contains t' amendments made undLi Section 49 and is correct fo 01 printing.---- Published Priority 22 January 1986; 22 January 1986 Related Art 00 00 0 0 0 0 o? 0 0 0 9 0 0 a 00a Name of Applicant Address of Applicant COLGATE-PALMOLIVE COMPANY 300 Park Avenue, New York New York 10022, United States of America o Actual Inventor/s Sandra Lee Schelm Linda Joy Vellekoop 00 00 0 000 0 00 00 0 o 00 Address for Service F.B. RICE CO., Patent Attorneys, 28A Montague Street, BALMAIN 2041.

0 0 00 0 0 0 Complete Specification for the invention entitled: STABILIZED DENTAL CREAM 0 00 o 0 0 o" The following statement is a full description of this invention including the best method of performing it known to us/A~:- -2- This invention relates to dental cream packaged in plastic laminate tube, mechanical dispenser, flexible sachet or the like. In particular it relates to dental cream in compatible contact with polyolefin surface of a package such as a plastic laminate dental cream tube, mechanical dispenser or flexible sachet.

Dental creams have been packaged for many years in flexible metal tubes such as wax lined lead tubes, unlined aluminum tubes or aluminun tubes having an expoxy resin lacquer coating thereon. In recent years flexible form-retaining laminated plastic tubes have been oo increasingly used.

o Plastic laminated dental cream tubes typically comprise an inner polyolefin resin layer which is in direct contact with the dental cream and at least one i 0 "intermediate layer, including an aluminum foil layer which inhibits loss of flavor from the dental cream.

Desirably, an intermediate paper layer which provides stiffness to the tube is also present. The outer layers 020 are typically of polyolefin resins, one of which may be 0o colored white and bears printed indicia with a clear a, oo polyolefin laminate over-lay to protect the indicia.

S0 Additional intermediate laminate layers of flexible plastic may also be present.

Mechanical dental cream dispensers may also have a polyolefin surface in contact with dental cream contained S therein. In fact, the polyolefin itself may be the housing of the dispenser. Flexible sachet packets may also have a polyolefin surface in contact with dental areas.

Dental creams typically contain a liquid vehicle of water and humectant, a gelling agent solid vehicle and a water-soluble dental polishing agent. Dental creams composed of such materials wherein the humectant comprises glycerine and sorbitol and the polishing material is at -3least in major part a water-insoluble alkaline earth metal salt or an alpha alumina trihydrate have been successfully packaged in flexible metal toothpaste containers including aluminum tubes having an internal coating of an epoxy resin lacquer layer. However, it is observed that when such dental creams are packaged in containers having an interior polyolefin surface such as plastic laminated dental cream tubes, mechanically operated dental cream dispensers or flexible sachets, that syneresis occurs and liquids separate from solids, rendering the dental cream undesirable, when the polishing material is an alkaline 2 ,earth metal salt or an alpha-alumina trihydrate with the pH of the dental cream reduced with a water-soluble I 15material which provides phosphate ion.

It is an advantage of this invention that phase separation of a dental cream packaged in contact with a polyolefin material is substantially prevented. Other advantages will be apparent from consideration of the following disclosure.

In prior development of dentifrices vegetable oils have occasionally been used for various purposes. For instance, U.S. Patent 1,551,638 to Brady describes a tooth paste containing glycerine, gum tragacanth, calcium carbonate, essential oils (clive and cinnamon) and Soap o o< 25 Lake salts from Soap Lake in Grant County, Washington State, which contain large amounts of sodium carbonate, sodium chloride and sodium sulphate, wherein the Soap Lake salts are saponified with oils such as cocoanut oil and peach kernel oil, which are vegetable oils.

Further in U.S. Patent 2,090,437 to Woldman, highly purified neutral oils of the glycerid type are described as being oily preserving liquids which do not leave the teeth and gums greasy Salad oils are stated to have this property. In addition these oils are described as being

L

4 compatible with sodium perpborate. Olive oil, peanut oil, palm oil and especially cotten-seed oilare indicated to be desirable.

In U.S. patent 1,488,907 to Creqer, the vegetable oil, oil of aniseed is set forth as an ingredient in an anti-pyorrhea tooth paste which also contains gum tragacanth, glycerine and calcium carbonate as well as oil of eucalyptus as a gummy exudation of fluid extracts from the bark of the Eucalyptus rostrata, commonly known as red gum, and redistilled oil of peppermint, an essential oil.

o In U.S. Patent 1,943,467 to Bley antiseptic dentifrices are described which may include a variety of oils as modifying and flavoring compounds. Disclosed oils 0C o include peppermint oil, peppermint oil substitutes, clove oil, cassia oil, cinnamon oil, thyme oil, nutmeg oil, caraway oil, bergamot oil, rose-geranium oil, neroli oil, lavender oil and lemon oil.

In U.S. Patent 2,089,529 to Behr, oils including ,o vegetable oils are described as imparting desired 20 consistency to tooth paste. Olive oil is particularly S° indicated as a tooth paste containing gum tragacanth and calcium carbonate.

In U.S. Patent 2,216,485 to Brandt, sulphonated petroleum extracts are stated to be used in manufacturing So 25 and stabilizing aqueous dispersions of water insoluble or s nearly water insoluble substances such as mineral oils, vegetable oils etc. In illustrative examples cocoanut oil fatty acid is included in a lather shaving cream while a milk of magnesia dental cream contains sulphonated mineral oil extract.

U.S. Patent 4,525,342 to Weiss et al describes compositions including toothpastes containing vegetable oils to reduce halitosis. Humectant materials are not disclosed.

In accordance with certain of its aspects, this ::i i 4 gl 5 0 P oo GO 0 00 oU 0 C-0 000 invention relates to a stabilized dental cream in compatible contact with a polyolefin surface of a package, said dental cream comprising at least about 20% by weight of a liquid vehicle comprising water, glycerine, sorbitol, and a vegetable oil, the weight ratio of glycerine to sorbitol being from 0.25:1 to about 3:1 and the amount of said vegetable oil being about by weight, a solid vehicle comprising about 0.05%-10% by weight of gelling agent, about 20-75% by weight of a dentally acceptable water-insoluble polishing material, at least a major portion of which is a water-insoluble alkaline earth metal salt or is alpha-alumina trihydrate and when alpha-alumina trihydrate is present as the major portion of the polishing material, there is present a water-soluble material to reduce the pH of the dental cream to about 6-8 which provides phosphate ion.

In dental cream formulations, the liquids and solids necessarily proportioned to form a creamy mass of desired consistency which is extrudible from its package. The liquids in the present dental cream comprise chiefly water, glycerine and sorbitol.

The total liquid vehicle comprises at least about by weight of the formulation. It is preferred to use also a gelling agent in dental creams such as the natural and 25 synthetic gums and gumlike materials e.g. carrageenans such as Irish moss, iota-carrageenans, gum tragacanth, sodium carboxymethyl cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, sodium alginate, guar gum, starch, xanthan and the like, including mixtures thereof. Irish Moss, sodium carboxymethyl cellulose and hydroxyethyl cellulose including mixtures thereof are compatible particularly and are preferred gelling agents when the major polishing agent is water-insoluble alkaline earth metal salt, iota-carrageenan is also a preferred gelling agent. The gum content is usually in an amount about 0.05-10% and preferably about 0.5-5% by weight of the So 6i 0 0 0o O 0 o00 0 o 0o 0a 0 0 a>- 6 formulation.

Water is preferably incorporated into the dental cream in amount of about 10-50% by weight, more preferably about 15-35%. Glycerine and sorbitol together preferably comprise about 15-50% by weight, more preferably about 20-35% of the dental cream, with the weight ratio of glycerine to sorbitol being from about 0.25:1 to about 3:1, typically from about 0.25:1 to about 0.8:1 and preferably from about 0.6:1 to about 0.8:1. Amounts of sorbitol as used herein are of sorbitol syrup, as commercially available, that is by weight sorbitol in 30% by weight of water.

Vegetable oils disperse readily in the liquid vehicle and while providing desirable sensory effects are also on no o 9 effective to prevent the dental cream from undergoing 15 syneresis when in direct contact with a polyolefin resin surface of a dental cream package. Vegetable oils are no obtained by extraction of oil from seeds of plants, particularly vegetable or fruit plants. They are well described in Vegetable Fats and Oils, Jamieson, Chemical Catalog Co., Inc. New York, 1932 and Food Industries Manual, 20th Edition, Woollen, Chemical Publishing Co., New York, 1970. Many particular vegetable oils are listedin appendix Tables 12, 16, 17 and 18 of Vegetable oa o Fats and Oils (pages 414-423) and in Table 6.1 of Food Industries Manual, ,0th Edition (pages 200-201). Of the vegetable oils, coconut oil, palm oil, peanut oil and safflower oil are observed as particularly effective in reducing syneresis with coconut oil being preferred, based upon overall performance. Vegetable oil is employed in the dental cream in amount of about 0.1-5% by weight, preferably about 0.5-2%.

Dentally acceptable water-insoluble polishing agent is present in the dental cream in amount of about 20-75% by by weight, preferably about 35-60%. At least the major portion, that is, about 50-100 of the polishing material 7 is water-insoluble alkaline earth metal salt or alpha-alumina trihydrate.

Typical water-insoluble alkaline earth metal salts include dicalcium phosphate dihydrate, anhydrous dicalcium phosphate, calcium carbonate, tricalcium phosphate, calcium pyrophosphate, dimagnesium phosphate trihydrate and magnesium carbonate including mixtures thereof. Most preferably, calcium salt, particularly dicalcium phosphate dihydrate or mixture of dicalcium phosphate dihydrate and anhydrous dicalcium phosphate, is present.

Dentally, acceptable water-insoluble alpha-alumina 0^ tooth-paste is typically employed in small particle size, 0° e.g. wherein at least about 85% of the particles are oo smaller than 20 microns and is preferably hydrated, such S 15 as that classified as gibbsite (alpha alumina trihydrate) and normally represented chemically as Al 2 0 3 3H 2 0 or Al(OH) 3 The average particle size of gibbsite is generally about 6 to 9 microns. However, larger particle S, size alpha-alumina trihydrate, e.g. wherein 20-70% of the 20 particles exceed 20 microns in size, may also be used. A particularly desirable grade of alpha-alumina trihydrate, available from Alcoa as C-333 is a fine grade of gibbsite having the following size distribution: Microns Percent 430 94-99 20 85-93 10 56-67 5 28-40 a Unless the Ph of the dental cream is adjusted, dental cream containing a substantial amount of alpha-alumina trihydrate is generally highly alkaline, e.g. about 9-10.5. Accordingly acidic materials are often added to such dental creams in order to reduce the pH, typically to about 6 to 8. Water-soluble phosphate materials, perticularly inorganic phosphate materials a-

I

8 are effective to produce such reduction in alkalinity.

Such materials include orthophosphates particularly orthophosphoric acid and alkali metal or ammonium monoacid orthophosphates or diacid orthophosphates.

Sodium diacid orthophosphate and hydrates thereof are preferred. The amount of these materials is that sufficient to adjust the pH to about 6-8: e.q. sodium diacid orthophosphate (monohydrate or anhydrous) is typically present in amount of about 0.15-0.50% by weight. Such phosphate pH adjusting materials render the dental creams subject to syneresis when in contact with a polyolefin resin surface unless additive is present to prevent syneresis.

>o When water-insoluble alkaline earth metal salt is the major component of the polishing material, alpha-alumina trihydrate, calcined alumina or other additional polishing agent may optionally be present in minor amount, for instance in a weight ratio of alkaline S earth metal salt to alumina material of about 2.5:1 to 20 about 4:1, the total amount of polishing material in the C n) dental cream being about 25-75% by weight.

When alpha-alumina trihydrate is the major a component of the polishing material, the minor portion of the polishing material, if present, typically S 25 comprises about 5-20% by weight of the polishing oo material, and may be polishing agent such as dicalcium, phosphate dihydrate, anhydrous dicalcium phosphate, calcium carbonate, tricalcium, phosphate, calcium pyrophosphate, dimagnesium phosphate trihydrate, magnesium carbonate, calcined alumina, zirconium silicate and insoluble sodium metaphosphate, Organic surface-active agents may be used in the dental cream of the present invention to achieve increased prophylactic action, assist in achieving thorough and complete dispersion of the instant K L

I:

9 o c-~ onor 00 C U f compositions throughout the oral cavity, and render the dental creams more cosmetically acceptable. The organic surface-active material may be anionic, nonionic, ampholytic or cationic in nature, but it is preferred to employ as the surface-active agent in a detersive material which imparts to the composition detersive and foaming properties. Suitable types of such detergents are water-soluble salts of higher fatty acid monoglyceride monosulphates, such as the sodium salt of the monosulphated monoglyceride of hydrogenated coconut oil fatty acids, higher alkyl sulphates, such as sodium lauryl sulphate, alkylaryl sulphonates, such as sodium dodecyl benzene sulphonate, olefinsulphonates, such as sodium olefin sulphonate in which the olefin group 15 contains 12-22 carbonatoms, higher alkyl sulphoacetates, higher fatty acid ester of 1,2-dihydroxy propane sulphonates, and the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acid compounds such as those having 12-16 carbon atoms in the fatty acid, alkyl or acyl radicals and the like. Examples of the last mentioned amides are N-lauroyl sarcosine, and the sodium, potassium, and ethanolamine salts of N-lauroyl, N-myristoyl or N-palmitoyl sarcosine, which should be substantially 25 free from soap or similar higher fatty acid material which tends to substantially reduce the effect of these compounds in composition of the present invention. The amides are particularly advantageous since they exhibit a prolonged and marked effect in the inhibition of acid formulation in the oral cavity due to carbohydrates break-down in addition to exerting some reduction in the solubility of tooth enamel in acid solutions. Another desirable material is a long chain fatty acid sodium monoglyceride sulphonate used alone or in combination with sodium lauryl sulphate.

CO

o Cu r C 0D C, 0 4 00,4 O A. 0,r r L7 -1 -1

I

10 Other particularly suitable, surface-active materials include nonionic agents such as condensates of sorbitan monostearate with approximately 20 moles of ethylene oxide, condensate of ethylene oxide with propylene glycol ("Pluronic" materials) and amphoteric agents such as long chain (alkyl) amino-alkylene alkylated amine derivatives, which are available under the trademark "Miranol" such as Miranol C 2 M. Cationic surface-active germicides and antibacterial compounds such as di-isobutyl phenoxy ethoxy ethyl dimethyl benzyl aammonium chloride, benzyl dimethyl stearyl ammonium chloride, benzyl diethyl stearyl ammonium chloride, tertiary amines having one fatty alkyl group (of from 0o 12-18 carbon atoms) and two (poly) oxyethylene groups attached. to the nitrogen (typically containing a total of from about 2 to 50 ethanoxy groups per molecule) and salts thereof with acids, and compounds of the structure

(CH

2 CH20) H

(CH

2

CH

2 0) H

R-N-CH

2

CH

2

CH

2

N-(CH

2

CH

2 0) H where R is a fatty alkyl group containing from about 12 to 18 carbon atoms, and x, y and z total 3 or higher, as well as salts thereof with mineral or organic acids, may also be used. It is preferred to use from about 0.05 to S 25 5% by weight of the foregoing surface-active materials in the dental cream. It is most preferred that the surface-active agent be an anionic material, particularly sodium lauryl sulphate.

The dental cream suitably may also contain a fluorine- containing compound having a beneficial effect on the care and hygiene of the oral cavity, e.g., diminution of enamel solubility in acid and protection of the teeth against decay. Examples thereof include sodium fluoride, stannous fluoride, potassium fluoride, potassium stannous fluoride (SnF 2 sodium 11 hexa-fluorostannate, stannous chlorofluoride, sodium fluorozirconate, and sodium monofluorophosphate. These materials which disassociate or release fluorine-containing ions in water, suitably may be present in an effective but non-toxic amount, usually within the range of about 0.01 to 1% by weight of the water soluble fluorine content thereof.

The preferred flourine-containing compound is sodium monofluorophosphate typically present in an amount of about 0.076 to 7.6% by weight, preferably S0.76%. A mixture of sodium monofluorophosphate and O sodium fluoride is also desirable, for instance in a -an weight ratio of about 2:1 based on fluoride.

,o Any suitable flavoring or sweetening materials may oj 15 be employed in formulating a flavour for the composition of the present invention. Examples of suitable flavoring constituents include the flavoring oils, e.g., oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon and 20 orange, as well as methyl salicylate. Suitable "OJ sweetening agents include sucrose, lactose, maltose, xylitol, sodium o 6-methyl-3,4-dihydro-l,2,3-oxathiazine-4-one, sodium cyclamate, perillartine and sodium saccharin. Suitably, flavor and sweetening agents may together comprise from sc about 0.01 to 5% or more of the compositions of the *fu instant invention.

Various other materials may be incorporated in the dental cream. Examples thereof are coloring or whitening agents or dyestuffs, anti-corrosive agents, silicones, chlorophylic compounds, ammoniated materials such as urea, diammonium phosphate and mixtures thereof and other constituents. Whitening agents, such as titanium dioxide, typically in amounts of about 0.5-2%, may be beneficial to the appearance of the dental -I1_Laldl__l. -12 composition, since upon aging, some discoloration may occur.

The adjuvants are incorporated in the instant compositions in amounts which do not substantially adversely effect the properties and characteristics desired and are selected and used in proper amounts depending upon the particular type of composition involved.

Antibacterial agents may also be employed in the oral compositions of the instant invention iu an amount of about 0.01-5% by weight. Typical antibacterial Sagents include:

N

1 -(4-chlorobenzyl)N 5 -(2,4-dichlorobenzyl) biguanide; o p-chlorophenyl biguanide; o 15 4-chlorobenzyhydryl biguanide; o c °4-chlorobenzhydrylguanylurea; N-3-lauroxypropyl-N 5 -chlorobenzylbiguanide: 1,6-di-chlorophenylbiquandohexane; 1,6-bis-(2-ethylhexylbiquanide) hexane; 1-(lauryldimethylammonium)-8-(p-chlorobenzyldimethyl- 0 ammonium) octane dichloride; 5,6-dichloro-2-guanidinobenzimidazole; s N 1 p-chlorophenyl-N 5 -laurylbiguanide; 5-amino-1,3-bis(2-ethylhexyl)-5-methylhexahy-dropyrimidine and their non-toxic acid addition salts.

In dental cream containing alkaline earth metal salt polishing agent may be employed also various o calcium and magensium ion suppression agents for adjustment of physical properties of the compositions.

Suitable agents are the water-soluble inorganic polyphosphate salts, such as tetrasodium pyrophosphate or di-sodium diacid pyrophosphate, with the partially neutralized or acid polyphosphate preferred. Other suitable agents are the alkali metal, preferably sodium, salts of citric acid. In general, such compounds will 13 be a minor amount or proportion of the formulation. The precise amount will vary depending upon the specific formulation, such as the physical characteristics of the dental cream, but will usually be from about 0.1% to about 3% by weight.

The dental creams should have a pH practicable for use. A pH range of 5 to 10 is particularly desirable for water-insoluble alkaline earth metal salt dental cream. The reference to the pH is meant to be the pH determination directly on the dental cream. If desired, materials such as citric acid may be added to adjust to oa o the pH to say 6 to 7. For alpha-alumina trihydrate S dental cream a pH of about 6-8, obtained with adjusting °onn° with a water-soluble material which provides phosphate 15 ion is particularly desirable.

o oThe package into which the dental cream is oo incorporated may be any polyolefin laminate dental cream tube. For instance, the tube may be as elementary as is described in U.S. Patent 3,260,410 to Brandt et al. As described in the example thereof, an aluminum foil base having a thickness of about 0.0013 cm was heated to a 0o. temperature of approximately 177 0 and one face of the heated foil was contacted by an extrudable film of a OoO,0. random copolymer of ethylene and acrylic acid (acid content 3+0.5% and melt index while the opposite surface thereof had placed thereagainst a film of lower 4 density polyethylene.

Using driven rolls a laminated base was obtained in which the copolymer layer was about 6 mils and the polyethylene layer was approximately 5 mils in thickness. The base was then shaped into tubular form and sealed.

After severing the tubular form into tube bodies, the tubes can be packed with the dental cream of the present invention.

14 00 0 0 00 0 0 0 0u 00 0 L 0e 0 0 0O 0b 0 Polyolefin laminate dentifrice tubes containing more intermediate layers may also be sucessfully used with the dental cream of the present invention without undergoing syneresis. For instance, the multiple layer flexible sheet structure for dental cream tubes described as "Prior Art" in U.S. Patent 4,418,841 to Eckstein may be employed as well as the more crack resistant structures described therein. In fact, dental creams of the present invention packed in tubes of sheet material identified as Prior Art and A-1 in U.S. Patent 4,418,841 are very satisfactory and undergo substantially no syneresis. Such tubes A and A-1 are comprised of layers as set forth below, in the order of outermostlayer to innermost layer.

A A-1 1.5 mil LDPE 1.5 mil LDPE mil Pigmented LDPE 2.0 mil Pigmented LDPE 1.6 mil Paper 1.6 mil Paper 0.7 mil LDPE 2.0 mil LDPE 3.3 mil EAA 1.0 mil OPP 0.7 mil Foil 1.0 mil EAA 2.0 mil EAA 0.7 mil Foil 1.2 mil LDPE 2.0 mil EAA 13.0 mil Total 1.2 mil LDPE 25 13.0 mil Total In A and A-1 the abbreviations have the following meanings: LDPE low density polyethylene EAA ethylene acrylic acid OPP oriented polypropylene Mechanically operated dispensers, such as the dispenser for, in particular, pasty substances, described in U.S. Patent 4,437,591 to von Schuckmann, the disclosure of which is incorporated herein by reference, may also be used with the practice of the Ai 1i 15 present invention. The housing of such dispensers is commonly composed of a polyolefin resin such as polypropylene. Thus the housing resin is in essence a layer, the inner surface of which is in contact with dental cream. When the dental cream of the present invention is packaged in such a polypropylene mechanical dispenser, it undergoes substantially no syneresis.

The advantages of the invention are also present when the dental cream is packed in a flexible sachet having an polyolefin surface, typically of low density or medium density polyethylene.

The following illustrative examples are further indicactive of the nature of the present invention but it is understood that the invention is not limited 15 thereto. All amounts and proportions are by weight except as otherwise indicated.

ioon o 0 0Qo 0 00oo 0 0 0 0 C EXAMPLE 1 The following dental creams are preapred to creamy consistencies and packed into tubes of each of laminated structures A and A-1 set forth above: o so o 0 9 0 00 oo 0 0 0 n0 0a o Glycerine Sorbitol (70%) Sodium. Carboxymethyl cellulose Sodium Saccharin Sodium Monofluorophosphate Sodium Diacid Orthophosphate monohydrate Deionized waterirradiated Alpha-alumina 8.000 15.800 1.000 0.200 Parts 2 8.000 15.500 1.000 0.200 3 8.000 15.000 1.000 0.200 4 8.000 16.000 1.000 0.200 0.760 0.760 0.760 0.760 0.250 0.250 0.250 0.250 19.700 19.700 19.700 19.700 i' 16 trihydrate (C-333) 52.000 52.000 52.000 52.000 Sodium lauryl sulfate 1.200 1.200 1.200 1.200 Flavor 0.890 0.890 0.890 0.890 Coconut oil 0.200 0.500 1.000 pH 7.1 7.0 6.9 After aging for at least 13 weeks at 25 0 C, dental creams and remain creamy in consistency in laminate tubes of each laminate structures A and A-1 with no observed syneresis and dental cream (1) undergoes only slight syneresis while dental cream (4) separates into liquid and solid phases within 1 week at 25 0 C in both of tubes of structures A and A-1.

EXAMPLE 2 Dental creams to are incorporated into a 15 mechanical dispenser in accordance with U.S. Patent 4,437,591 composed of polypropylene housing. Dental creams and retain their creamy consistency with little or no syneresis while dentifrice (4) separates into liquid and solid phases.

EXAMPLE 3 Similar results with respect to phase separation to those described above for Examples 1 and 2 are observed re OP s o B1t 00 0-0 0 0 0 0 0060 a O o 0000 00 0 i 0 00 0 a0 0 0 4 1 when: the relative amounts of glycerine and sorbitol are: 6:24 and 18:6 and (ii) each of palm oil, peanut oil and safflower oil are used in place of coconut oil; (iii) The dental creams are packed in laminated tubes in accordance with U.S. Patent 3,260,410; (iv) The dental creams are packed in crack-resistant laminated tubes in accordance with U.S. Patent 4,418,841; The dental creams are packed in flexible sachets of the following structure from outermost to innermost layer: ;i 1 17 12.2 p polyethylene terephthalate 21.3 p white ethylene acrylic acid p foil 3.3 p ethy'ene acrylic acid 25.4 p medium density polyethylene; (vi) Mixture of 0.3 parts of sodium carboxymethyl-cellulose and 0.6 parts of xanthan replace of sodium carboxymethyl cellulose as the sole gelling material; (vii) 3.000 parts of calcined alumina replace 3.000 parts of alpha-alumina trihydrate; and o oo (viii) 10 parts of insoluble sodium metaphosphate 0 o replace 10.000 parts of alpha-alumina trihydrate; (ix) sodium cyclamate replaces sodium saccharin.

15 EXAMPLE 4 nno The following dental creams are prepared to creamy 0" consistencies and packed into tubes of each of laminated strucures A and A-i set forth above: (1) (2) 14 a 0a 0 00 0 OI Glycerine 10.00 10.00 Sodium monofluorophosphate 0.76 0.76 Sodium Benzoate 0.50 0.50 Sodium Carboxymethyl cellulose 0.95 0.95 Tetrasodium Pyrophosphate 0.25 0.25 Sodium Saccharin 0.20 0.20 Sorbitol 70% Solution 17.00 18.00 Coconut oil 1.00 Deionized water irradiated 18.49 18.49 Dicalciumi phosphate dihydrate 48.76 48.76 Flavor 0.89 0.89 Sodium lauryl sulfate 1.20 1.20 After aging for 6 weeks at 25%C, dental cream (1) remains creamy in consistency in each of laminate tubes of structures A and A-l, while dental cream (2) 18separates into liquid solid phases within 3 weeks at in both of tubes of structures A and A-i.

EXAMPLE Dental creams and are incorporated into a mechanical dispenser in accordance with U.S. Patent 4,437,591 composed of polypropylene housing. Dental cream retains its creamy consistencies while dental cream separates into liquid and solid phases.

EXAMPLE 6 Similar results to those described above are observed when: o calcium carbonate replaces dicalcium phosphate a dihydrate; (ii) dimagnesium phosphate trihydrate replaces S 15 dicalcium phosphate dihydrate; (iii) the comparative amounts of glycerine and sorbitol are 6:24; and 18:6; (iv) coconut oil is replaced by each of palm oil, peanut oil and safflower oil; The dental creams are packed in laminatd tubes in 00 accordance with U.S. Patent 3,260,410; Soo, (vi) The dental creams are packed in crack-resistant laminated tubes in accordance with U.S. Patent 4,418,841; (vii) The dental creams are packed in flexible sachets of the following structure from outermost to So0 innermost layer; 12.2 p polyethylene terephthalate 21.3 p white ethylene acrylic acid 9.0 foil 3.3 ethylene acrylic acid 25.4 p medium density polyethylene; (viii) Sodium cyclamate replaces sodium saccharin.

It is understood that the foregoing detailed description is given merely by way of illustration and 19 that variations may be made therein without departinq from the spirit of the invention.

00 it-I 00 0 0 o 000*~ ~~iCC Q 01' o o 0 0 00 0 0000 00 4 0 44 00 04 O 0 4 o 04 00 4 411134 04 0 0 4

Claims (21)

1. A stabilized dental cream in compatible contact with a polyolefin surface of a package, said dental cream comprising at least 20% by weight of a liquid vehicle comprising water, glycerine, sorbitol and a vegetable oil, the weight ratio of glycerine to sorbitol being from 0.25:1 to 3:1 and the amount of said vegetable oil being by weight, a solid vehicle comprising 0.05-10% by weight of gelling agent, 20-75% by weight of a dentally acceptable water-insoluble polishing material, at least a major portion of which is a watec--v.iluble alkaline earth metal salt or is alpha-alumina trihydrate, and when alpha-alumina trihydrate is present as the major portion of the polishing material, there is present a water-soluble material to reduce the pH of the dental cream to 6-8 which provides phosphate ion.

2. The stabilized dental cream claimed in Claim 1 wherein the weight ratio glycerine to sorbitol is from 0.25:1 to 0.8:1.

3. The stabilized dental cream claimed in Claim 2 wherein the weight ratio glycerine to sorbitol is from a o0 40 O0 0 ao o o 0 o ft .ya iZ 0 0? 000 0 0 0 00440s 0r 4 00 00 0 0 0 0 0.6:1 to 0.8:1.

4. The stabilized dental wherein said vegetable oil by weight.

5. The stabilized dental wherein said vegetable oil consisting of coconut oil, safflower oil.

6. The stabilized dental wherein said vegetable oil

7. The stabilized dental wherein said alpha-alumina polishing agent present. cream claimed in Claim 1 is present in amount of 0.5-2% cream claimed in Claim 1 is selected from the group palm oil, peanut oil and cream claimed in Claim is coconut oil. cream claimed in Claim 1 trihydrate is the sole T i~ -21

8. The stabilized dental cream claimed in Claim 1 wherein said material which reduces the pH is inorganic.

9. The stabilized dental cream claimed in claim 8 wherein said inorganic material which reduces the pH provides orthophosphate ion.

The stabilized dental cream claimed in Claim 9 wherein said material containing orthophosphate ion is selected from the group consisting of orthophosphoric acid, alkali metal diacid orthophosphate, ammonium diacid orthophosphate, alkali metal monoacid orthophosphate and ammonium monoacid orthophosphate.

11. The stabilized material claimed in Claim 10 wherein said material containing orthophosphate ion is a sodium diacid ortho-phosphate.

S12. The stabilized material claimed in Claim 12 wherein o said sodium diacid orthophosphate is sodium diacid orthophosphate monohydrate.

13. The dental cream claimed in Claim in 1 wherein said o 4 water-insoluble alkaline earth metal salt is present and is a calcium salt.

14. The dental cream claimed in Claim 13 wherein said calcium salt is dicalcium phosphate dihydrate.

15. The dental cream claimed in Claim 1 wherein said dental cream ~s packaged in a plastic laminate tube.

16. The dental cream claimed in Claim 15 wherein the inner polyolefin resin surface of said plastic laminate tube is polyethylene.

17. The dental cream claimed in Claim 16 wherein said polyethylene is low density polyethylene.

18. The dental cream claimed in Claim 1 wherein said dental cream is packaged in a mechanical dispenser having a housing of polyolefin resin. 4 22

19. The dental cream claimed in Claim 18 wherein said polyolefin resin of said housing is polypropylene.

The dental cream claimed in Claim 1 wherein said dental cream is packaged in a flexible sachet.

21. The dental cream claimed in Claim 20 wherein the inner polyolefin resin surface of said sachet is low density polyethylene or medium density polyethylene. Dated this 21st day of January 1987 COLGATE-PALMOLIVE COMPANY Patent Attorneys for the Applicant F.B. RICE CO. 0 0 0 0a 0000 o1 0 0( toE *0