Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Patent
1994-06-15
1998-11-10
Rose, Shep K.
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
424 49, 424 54, A61K 716, A61K 718, A61K 722
Patent
active
058339582
DESCRIPTION:
BRIEF SUMMARY
This is a Rule 371 of PCT/GB92/02348 filed Dec. 17, 1992. This invention relates to oral hygiene compositions and in particular to dentifrices comprising particular antibacterial agents which compositions are useful in antiplaque therapy.
Oral hygiene compositions for use in antiplaque therapy generally comprise an antibacterial agent as the antiplaque agent. Antibacterial agents already used in various oral hygiene compositions include cationic antibacterial agents such as chlorhexidine digluconate and cetyl pyridinium chloride and non-cationic antibacterial agents such as triclosan.
Another class of antibacterial agents are the bacteriocins. These have been defined as proteinaceous substances produced by bacteria and which have antibacterial activity only against species closely related to the species of origin. More recently it has been found that, at least in certain instances, the spectrum of antibacterial activity may in fact be broader.
An example of a bacteriocin which has already found commercial application is nisin. This is a lanthocin, comprising the atypical amino acid lanthionine. Nisin is a polypeptide with antibacterial properties which is produced naturally by various strains of the bacterium Streptococcus lactis. It is also a naturally occurring preservative found in low concentration in milk and cheese. Nisin has recently been recognised by the FDA as a direct food ingredient. A summary of nisin's properties is to be found in Advances in Applied Microbiology 27 (1981), 85-123.
Recently, a purified form of nisin has been made available by Applied Microbiology Inc under the trade name AMBICIN N. It has been suggested for use in a variety of applications including oral care, as disclosed in PCT Application WO 89/12399 to Blackburn et al., and now in issued U.S. Pat. No. 5,135,910 for use in the oral cavity. U.S. Pat. No. 5,135,910 specifically includes in the formulations of the lanthione antibacterial agents the use of all surfactants, including those which are anionic.
However, it has now been found that the bactericidal activity of the bacterocin derivatives, particularly nisin, is incompatabile with anionic surfactants. As far as we are aware, no specific proposals for a dentifrice formulation have been proposed which has recognized this particular problem.
Accordingly, the present invention provides for a dentifrice formulation which comprises an antibacterially effect amount of a bacteriocin antibacterial agent and an orally acceptable carrier or excipient which composition does not contain an anionic surfactant.
We have found that bacteriocin antibacterial agents such as nisin are incompatible with conventional dentifrice bases that contain strong anionic surfactants, such as sodium lauryl sulphate and sodium N-methyl-N-cocyl laurate which are conventionally used in such bases. It is believed that the strong anionic surfactants reversably inactivate or inhibit the bacteriocin antibaterial agents which tend to be positively charged. Care must therefore be exercised in selecting suitable surfactants for their compatibility with the antibacterial agent.
When used herein, in respect of a dentifrice ingredient, the term "compatible" is used to mean that the activity of the bacteriocin is not substantially compromised by the presence of the ingredient. Suitably that activity in the presence of the ingredient should not be less than 40%, preferably less than 50%, advantageously less than 60% of that observed in the absence of the ingredient. This may be readily checked by bioassay, for instance the zone diffusion assay described in example 4.
Suitable bacteriocin antibacterial agents include nisin, gramicidin and tyrothricin and purified forms of bacteriocins such as AMBICIN N. Nisin and in particular the purified form thereof AMBICIN N are especially preferred.
Suitably, the dentifrice comprises from 0.001 to 5.0%, preferably from 0.005 to 2.0%, advantageously from 0.02 to 1.0% of bacteriocin antibacterial agent by weight of the composition. In an alternative manner the level of baceterioc
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Int. J. Clin. Pharm. Res. vol. 4, No. 8, 1988 pp. 259-261 Matula et al 'Salivary Levels of Gramicidin After Use A Tyrothricin-Containing Gargle/Mouth-Wash and Thyrothricin Lozenges.
Doel Geoffrey Royston
Smith Andrew William
Ambi Inc.
Rose Shep K.
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