Dental care compositions

Details Dental care compositions Dental care compositions

2003-04-25

2004-02-03

Rose, Shep K. (Department: 1614)

Drug, bio-affecting and body treating compositions

Dentifrices

C433S228100, C523S116000, C523S118000

Reexamination Certificate

active

06685921

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to oral care compositions, which comprise a silicone resin, a silicone gum and a silicone fluid, and to the use of such oral care compositions to treat the hard and soft tissue surfaces of the oral cavity. More particularly, this invention relates to silicone oral care compositions which form a substantive film on the surface of the teeth or gums treating these surfaces and which are readily removed by brushing, rinsing or eating at the end of the treatment period. According to one aspect of this invention the compositions can also comprise an oral care active and as such can provide sustained delivery of this active to the tissues of the oral cavity. Compositions of the present invention are particularly useful for delivering of oral care actives, which either enhance the appearance of the teeth or provide therapeutic and/or prophylactic benefits.
BACKGROUND
Many consumers have a good understanding of the prophylactic, therapeutic and cosmetic benefits of maintaining high standards in oral hygiene. These benefits include reduction in caries, plaque, gingivitis and tartar; treating hypersensitivity; freshening breath; whitening teeth and removing stains; remineralising teeth and the like. To date, a wide variety of oral care products are available which, over the short term, aid the maintenance of good oral hygiene by delivering various oral care substances or actives to the soft and hard tissues of the oral cavity. In general such products exist in the form that they are used by the consumer themselves either at-home or away from the home and/or are administered by dentists/hygienists as part of their professional routine of oral hygiene treatments. Specific examples of such products, particularly those for use by the consumer themselves, include dentifrices containing for example anti-caries actives and/or anti-bacterial plaque reducing actives; mouth washes containing breath freshening actives and/or anti-bacterial actives; and chewing gums containing tooth whitening actives.
The most frequently used oral hygiene treatments are those administered by the consumer themselves and it is usual that these are practised, in the Western world, either once or twice a day. However, many of the processes which lead to a deterioration in the tissues of the oral cavity are on-going and, as such, can only be effectively treated, either prophylactically or therapeutically, by continuous attention which is impractical or by the use of long lasting treatments. To date, conventional product forms do not typically provide long lasting, prolonged or sustained therapeutic, prophylactic and/or cosmetic treatment benefits. Instead the preparations take effect only for the relatively short period of time during which the teeth are being cleaned or the mouth is being rinsed and, after product use, the active level on the hard and soft oral tissues diminishes rapidly. Thus, until now, the only way to achieve sustained active release with conventional products has been to periodically reapply the product or to use a special delivery device or containment means such as a mouthpiece. It would therefore be desirable to have an oral care product comprising one or more active substances which is itself substantive within the oral cavity and wherein the oral care product has a pleasant mouth feel such that its aesthetics are acceptable for long term use in the oral cavity. It is also desirable to have a substantive oral care product wherein the active substances are released over a sustained period of time and thus able to provide a long lasting benefit. Finally it would be desirable if this oral care product was easily removed at the end of the treatment period such that no damage is sustained to the hard or soft tissues of the oral cavity in removing the product and such that the oral care product is suitable for home use by the consumer without the need for professional assistance. Furthermore such compositions would be especially useful in the many less well developed areas of the world where prophylactic professional dental hygiene is less commonly available.
Several attempts have previously been made to enhance the substantivity of active components of oral care products within the oral cavity. These attempts include the use of film forming polymers to deliver various actives for example bleaching agent (U.S. Pat. No. 5,425,953, International Patent Appln. No. PCT/CN97/00004 published on Jul. 24, 1997 as WO 97/25968); bactericidal pharmacological agent (U.S. Pat. No. 5,438,076); anti-plaque cationic bactericide (EP 0,864,315); fluoride ions (U.S. Pat. No. 5,989,535) etc. However, because some of the above systems are water soluble they readily dissolve in saliva and therefore their degree of durability is relatively low and they can not provide long term delivery of the active ingredient. In addition, their water soluble nature precludes them from being used in conjunction with oral care actives that would be unstable in water based films, for example sodium percarbonate. A second strategy that has been disclosed in the art for the improvement of the substantivity of actives within the oral cavity is the use of materials which are able to adsorb to the tissue. For example U.S. Pat. No. 3,956,480 discloses compositions in which cationic germicide and anionic polymer are adsorbed onto the hydroxyapatite surface of the teeth; EP0736544 discloses the use of antibodies to adhere to specific proteins in the oral cavity for example in the pellicle structures; EP 1,027,877 and U.S. Pat. No. 5,139,768 disclose compositions comprising hydrophobic polymers for example cellulosic or carbonyloxycarbonyl polymers to achieve substantivity; and WO 93/24103 discloses an antimicrobial agent supported on an inert oxide synthetic particulate which adsorbs onto the tooth enamel. However, these methods are limited in that the materials tend to have a preferred affinity for the hard tissues of the oral cavity and furthermore they can be limited in the type of oral care actives that can be incorporated. Higher degrees of durability have been achieved by the use of hard protective coatings on the teeth. For example U.S. Pat. No. 5,401,528 discloses the polymerisation of organically modified silicic acid polycondensates to coat the teeth; similarly U.S. Pat. No. 5,888,491 discloses the use of polymers grafted to polysiloxane chains for providing a highly substantive coating to the hard tissues within the oral cavity. However these complete coating systems are often unsuitable for home use, feel unnatural and the coating itself can still be subject to the deleterious effect of plaque-causing bacteria.
Silicones have a wide variety of uses in the dental industry including use as denture adhesive compositions (WO93/14737); non substantive neutral films (U.S. Pat. No. 5,032,387) and rubber materials for taking impressions (EP 822233). Furthermore it has long been recognised that polysiloxanes can be used within oral care compositions to provide a smooth, very thin water repellent coating to the teeth where they provide a hydrophobic surface and are thereby able to prevent the formation of caries and staining (GB 686,429, WO 93/23009 and WO95/03776). It has also been shown that, whilst the polysiloxane coating remains in place, it is able to act as a slow release reservoir for lipid soluble actives eg anti-bacterial agents (U.S. Pat. No. 5,422,098). However, polysiloxanes themselves adhere to the teeth for only a short period of time so attempts have been made to enhance the substantivity by modifying the silicone oil for example by use of quaternised tertiary cyclic amines (GB 789,851); quaternary ammonium groups (U.S. Pat. No. 4,161,518) and aminoalkyl groups in conjunction with a lipophilic actives (EP 0,528,457). The initial work has been further extended with the applications WO 96/19190, WO 96/19191, WO 96/19192, and WO 96/19563 which disclose alkyl, alkoxy- and aminoalkyl-dimethicone copolyol oral compositions for use on teeth or acrylic surfaces of dentures comprising a

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