Drug – bio-affecting and body treating compositions – Dentifrices – Ammonia – amine – or derivative thereof
Patent
1998-11-25
2000-09-12
Rose, Shep K.
Drug, bio-affecting and body treating compositions
Dentifrices
Ammonia, amine, or derivative thereof
424 49, A61K 716, A61K 722
Patent
active
061174173
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a mouthwash composition cetyl pyridinium chloride (CPC) and an amphoteric surfactant.
The use of cationic antibacterial agents such as CPC in oral hygiene compositions has been widely advocated as a means of reducing the bacterial plaque population and this may be beneficial in the prophylaxis and/or treatment of mouth odour, periodontal disease, plaque, calculus and/or caries.
Whilst mouthwashes comprising CPC are available these can suffer the disadvantage of reduced efficacy due to CPC deactivation caused by the presence of any anionic excipients within such mouthwashes.
Although nonionic surfactants have previously been suggested for use with cationic antibacterial agents it has now been found that many such surfactants can reduce the efficacy of mouthwashes comprising CPC.
Surprisingly it has now been found that particular amphoteric amidobetaine surfactants are more compatible with CPC than nonionic surfactants such as polyethoxylated sorbitol esters, polycondensates of ethylene oxide (polaxamers) and polyethoxylated hydrogenated castor oils.
The present invention therefore provides a mouthwash composition comprising a bacteriostatically effective amount of CPC; an orally acceptable carrier or excipient and an amidobetaine of the formula: CO.sub.2.sup.-
Suitable examples of amidobetaines include cocoamidoethylbetaine, cocoamidopropylbetaine or lauramidobetaine or mixtures thereof. A preferred amidobetaine is cocoamidopropylbetaine which has been found to be especially compatible with CPC in mouthwash formulations.
Suitably the CPC is present in the range 0.005 to 10%, preferably 0.01 to 5%, more preferably 0.02 to 2.5% by weight of the mouthwash.
Suitably the amidobetaine is present together with another surfactant selected from a nonionic, another amphoteric or a cationic surfactant, or mixtures thereof.
Suitable nonionic surfactants include, for example, polyethoxylated sorbitol esters, in particular polyethoxylated sorbitol monoesters, for instance, PEG(40) sorbitan di-isostearate, and the products marketed under the trade name `Tween` by ICI; polycondensates of ethylene oxide and propylene oxide (poloxamers), for instance the products marketed under the trade name `Pluronic` by BASF-Wyandotte; condensates of propylene glycol; polyethoxylated hydrogenated castor oil, for instance, cremophors; and sorbitan fatty esters.
Suitable alternative amphoteric surfactants include, for example, long chain imidazoline derivatives such as the product marketed under the trade name `Miranol C2M` by Miranol and long chain alkyl betaines, such as the product marketed under the tradename `Empigen BB` by Albright+Wilson and mixtures thereof.
Suitable cationic surfactants include the D,L-2-pyrrolidone-5-carboxylic acid salt of ethyl-N-cocoyl-L-arginate, marketed under the trade name CAE by Ajinomoto Co. Inc., and cocamidopropyl PG dimonium chloride phosphate and lauramidopropyl PG dimonium chloride phosphate, available under the trade names Monaquat PTC and Monaquat PTL, respectively, from Mona Corporation.
Suitably between 50 to 100% of the surfactant is present as an amidobetaine.
Preferably between 65 to 90% of the surfactant is present as an amidobetaine.
More preferably an amidobetaine is present as the sole surfactant.
Suitably the total surfactant is present in the range 0.01 to 20%, preferably 0.05 to 10%, more preferably 0.1 to 5% by weight of the mouthwash.
Suitable mouthwash formulations will have an aqueous base comprising water or aqueous ethanol, and optionally a further liquid such as glycerin or propylene glycol. Mouthwash compositions may be provided in a "ready to use" form; as a concentrated solution, for dilution by the user immediately prior to use; or in solid form, such as a tablet or in a sachet, for dissolution by the user immediately prior to use. Tablets may suitably be prepared using xylitol and/or sorbitol as the major ingredient. The sachets and tablets may be formulated to provide, on dissolution, a still mouthwash, or, by the incorporation of a suitable
REFERENCES:
patent: 4693888 (1987-09-01), Miyahara et al.
Derwent Publication Ltd., London, GB; AN 91-092240, Jul. 5, 1989, see abstract & JP03038516A, published Jul. 5, 1989.
Derwent Publication Ltd., London, GB; AN 95-220935, May 23, 1995, see abstract & JP07133492A, published May 23, 1995.
McConville Peter Scott
Walsh Paula
Wicks Mark Andrew
Kinzig Charles M.
Rose Shep K.
SmithKline Beecham p.l.c.
Stein-Fernandez Nora
Williams Janice E.
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