The present invention relates to a novel composition based on peroxidised lipids which can be used notably in the treatment of xerostomia.
Xerostomia is a well known pathology which manifests itself as a sensation of dryness of the mouth.
This pathology in general results from a sluggishness or of a definitive damage of the salivary glands which causes this phenomenon.
This inconvenient syndrome may become particularly incapacitating. A sensation of burning and of pain diffuses into the buccal cavity which hinders the patient considerably from eating or drinking.
The manifestations of xerostomia can be seen most often after a long-term treatment with neuroleptics, a treatment by irradiation or chemotherapy, or in the case of immunodeficiency.
No satisfactory treatment exists at the moment, but only some products which act on the symptoms by increasing salivary secretion, in replacing the saliva, or by stimulating the salivary glands. The main treatment which is used at the moment consists of using artificial saliva or saliva substitutes which are sprayed into the mouth.
In general, these products are swallowed without much therapeutic remanence.
Many saliva substitutes are thus marketed.
The formulation of the saliva substitutes usually tends to come close to the composition of natural saliva.
Products are also known which are intended to stimulate the salivary glands.
These are in general chewing gum products or pastilles.
Various peroxidised lipids are known which are notably obtained by peroxidation of natural plant oils. The following patents will be cited in particular: BSM (in French <<Brevet Spécial de Médicament>>, <<French Special Medicine Patent>> in English) N°2 330 M, EP-A-293 535, FR-A-2 591 112, EP-A-225 831, EP-A-225 832, EP-A-225 833, EP-A-226 506, FR-A-2 461 744, FR-A-2 539 142 and EP-A-117 962, which relate either to the preparation of such peroxidised lipids, or to their applications in various fields, particularly in the treatment of certain diseases in the field of rheumatology or traumatology, or even as a healing product.
The use of peroxidised lipids has also been described in European Patent Application EP 1 077 061 in the treatment or prevention of wounds and of inflammations of the mucous membranes of the buccal cavity.
Within the context of his research work on novel means of treating dry mouth syndrome, the inventor of the present invention has now discovered that peroxidised lipids, provided that they are formulated in a form of a composition which is compatible with an application as a spray, could be used in a particularly effective manner in the treatment of xerostomia, this formulation as a spray enabling the whole of the buccal cavity and the tongue to be lined by a simple vaporisation of said composition in the mouth.
It has thus now appeared that provided the peroxidised lipids are formulated in the form of a composition which has a well determined viscosity, linked to the presence of silica in well-determined proportions in the composition, it was possible to line the whole of the mucous membranes of the mouth in a particularly simple and effective manner by means of a dosing pump, and this led to the formation of a film lining the whole of the mucous membranes and causing a real action of lubrication of the mucous membranes of the mouth.
This type of composition and mode of action proves to be particularly interesting, at a time when means of treatment are particularly sought after which are as little aggressive as possible for the organism. Further, they enable the regulation of the European Community to be satisfied in relation to medical devices.
Furthermore, it will be noted that amongst the documents cited above describing compositions based on peroxidised lipids, a certain number of them exist which cite compositions which contain colloidal silica. However, in all of these documents which cite mixtures of peroxidised lipids and colloidal silica, viscous compositions are sought after which have the consistency of an oily gel which can be applied on the skin and the mucous membranes.
These gels still contain colloidal silica concentrations of greater than 4% by weight, and in general of greater than 6% by weight. Such compositions would not enable the function sought after according to the present invention to be fulfilled, wherein it is sought to line the mucous membranes of the buccal cavity totally by vaporising the composition in the form of a spray.