Drug – bio-affecting and body treating compositions – Dentifrices
Patent
1998-06-08
2000-05-02
Rose, Shep K.
Drug, bio-affecting and body treating compositions
Dentifrices
424 54, 424 58, A61K 716, A61K 722, A61K 726
Patent
active
060569441
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to pharmaceutical compositions for oral use which include a nonsteroidal anti-inflammatory agent (NSAI) and to their use for preventing and treating periodontal disorders.
NSAIs are not widely used for preventing and treating periodontal disorders, that is disorders which affect the periodontium, such as gingivites or periodontites. The periodontium consists of support tissues for the tooth. It is mainly composed of gingiva, ligament, alveolar bone and cementum. The limited use of NSAIs for preventing and treating periodontal disorders can be explained by the fact that, in general, compositions for oral use which include NSAIs are not sufficiently effective. Thus, while a relatively high dose of NSAI is required if this type of composition is to be adequately effective, such high doses of NSAI are, in general, poorly tolerated by the periodontium.
The present invention therefore proposes novel compositions for oral use, which compositions include NSAIs and exhibit an appreciably improved efficacy while at the same time being well tolerated by the periodontium. These compositions are useful for preventing and treating periodontal disorders.
The invention thus consists of a pharmaceutical composition for oral use, which includes a nonsteroidal anti-inflammatory agent (NSAI) and ceramides.
The applicant has observed that ceramides enable the NSAIs to be vectorized, that is they improve the availability of the NSAIs at the site of action. Thus, the ceramides, alone or in combination with other compounds described below, form a vectorizing base.
Ceramides are lipids which generally comprise from 14 to 34 carbon atoms, more generally from 17 to 23 carbon atoms. They are constituents of the plasma membranes of animal cells. They are also present in plants in the form of lipid mixtures which include, in particular, phospholipids such as lecithins in addition to the ceramides.
Ceramide derivatives are also known which comprise one or more monosaccharides which are attached to the constitutive carbon chain of the ceramides. These monosaccharides can consist of glucose, galactose, mannose, fucose, glucosamine or galactosamine. These ceramide derivatives which include one or more monosaccharides are an integral part of the present invention. For the sake of simplicity, and unless otherwise indicated, the term ceramide is understood, within the context of the present invention, as meaning both ceramides per se and said ceramide derivatives.
As indicated above, the ceramides can be used alone or in the form of mixtures which can, in particular, include, apart from the ceramides, other lipids such as phospholipids as well as, where appropriate, proteins.
Those mixtures which can be used within the context of the present invention, as well as the process for preparing them, are described in international application PCT/FR92/01048.
The ceramides of the invention are preferably of plant origin.
A pharmaceutical composition according to the invention can include from 0.005 to 5% by weight, preferably from 0.2 to 2% by weight, of ceramides.
The ceramides employed can be in the form of an aqueous emulsion whose oily phase consists, at least in part, of ceramides and, where appropriate, of other lipids.
The NSAI is advantageously selected from benzydamine, ketoprofen or ketoprofen lysine. A pharmaceutical composition according to the invention can include from 0.005 to 10% by weight, preferably from 0.25 to 2.5% by weight, of NSAI.
A pharmaceutical composition for oral use according to the invention can be in the form of dentifrices, mouthwashes or gels. Apart from the NSAI and the ceramides, the pharmaceutical composition can include at least one other excipient such as acrylic acid polymers, carboxyvinyl polymers, silicas, propylene glycol, polyethylene glycols, fatty acid esters, hard paraffin, ethanol, isopropanol, diethanolamine, triethanolamine, glycerol, hydroxyethylcellulose and carboxymethylcellulose (CMC), for gels; calcium carbonate or phosphate, hydrated aluminas or silicas, carboxymet
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Rose Shep K.
Synthelabo
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