Drug – bio-affecting and body treating compositions – Designated organic nonactive ingredient containing other... – Natural gum or resin
Patent
1996-09-23
1999-03-23
Cintin, Marianne M.
Drug, bio-affecting and body treating compositions
Designated organic nonactive ingredient containing other...
Natural gum or resin
5147724, 5147726, 514773, 514777, 514781, 514915, A61K 4700
Patent
active
058860541
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 PCT/NL95/00046 filed Feb. 2, 1995.
The present invention relates to a therapeutic composition for replacing and/or supplementing body fluids such as saliva and tears.
Saliva, tears and the like are of importance for maintaining a healthy environment in the mouth and eyes. It is not however self-evident that an individual can produce sufficient tear water or saliva. People who have had radiation treatment of the oral cavity, cervix or throat are for instance often no longer capable of producing sufficient saliva, because their salivary glands have been entirely or partially destroyed by the radiation treatment.
Another example is formed by those suffering from Sjogren syndrome, who may display symptoms like dry mouth and dry eyes in addition to rheumatic disorders. Sjogren syndrome is a progressive process which has a gradual adverse effect on the saliva production. 60% of the patients consists of women after the menopause. Sjogren syndrome is suspected of being an autoimmune disease.
Dry mouth also occurs regularly in users of medicine, particularly users of sedatives, .beta.-blockers, antihypertension medication, tranquilizers and others medicines which have the side-effect of dulling the nervous system.
A shortage of saliva or tear water can, in addition to the accompanying discomfort and irritation, moreover result in inflammations of the mouth and eyes.
In order to relieve the complaints of dry mouth and eyes saliva substitutes based on carboxymethyl cellulose (CMC) or animal mucins have been proposed (Levine et al., J. Dent. Res. 66:693-698 (1987)). In addition a saliva substitute based on linseed-extract is described in EP-0.511.181. In practice however these known substitutes are not found to be satisfactory. The effective duration of these products is only limited and compared to human saliva they do not possess the desired properties, such as elasticity, viscosity etc.
The object of the present invention is to provide a saliva substitute which approximates the properties of human saliva better than the known products, eliminates the dry sensation in mouth and eyes and needs to be applied less often.
To this end the invention provides a therapeutic composition, comprising a buffered, aqueous solution of at least one polymer and at least one electrolyte.
The polymer is preferably chosen from the group which consists of scleroglucan (in a concentration of about 0.001% to 2% (w/v)), guar gum (about 0.001% to 5% (w/v)), xanthane gum (about 0.001% to 2% (w/v)), sodium carboxymethyl cellulose (for instance of the type Blanose.RTM. 7HF, in a concentration of 0.01 to 5% (w/v)), hydroxyethyl cellulose (for instance of the type Natrosol 250 HX Pharm, in a concentration of 0.01 to 5% (w/v)), polyacrylic acid (for instance of the types Carbopol 934P.RTM. and Carbopol 974P.RTM., in a concentration of 0.01 to 5% (w/v)) and polyvinyl alcohol (for instance with a degree of hydrolysis between 71.6 and 100 mol %, an ester value between 0 and 285 g KOH/g, a molecular weight between 14,000 and 205,000 and a degree of polymerization between 360 and 4500). Another suitable product can however be chosen as desired from the large supply of available polymers, and particularly polysaccharides.
At least one mucin can optionally be added to the composition. The electrolyte can for instance be chosen from the group consisting of sodium, potassium, fluoride, chloride, phosphate, CNS, rhodanide. The composition can further also contain calcium and/or at least one phosphate compound, as well as flavourings and/or aromatic substances and/or colourings and preservative.
The invention further relates to saliva substitutes or additives, artificial tear water or tear additives, mouth rinses and toothpastes, comprising the therapeutic composition according to the invention.
The advantages of the present invention will become apparent from the example hereinbelow, which is however only intended as illustration and further implies no limitation whatever to the scope of the invention.
EXAMPLE 1
Xanthane gum (
REFERENCES:
patent: 4039662 (1977-08-01), Hecht et al.
patent: 5078129 (1992-01-01), Kleinberg et al.
The Merck Index (11.sup.th Ed.) Budavari et al., Merck and Co., Inc., Rahway, NJ. (1989), p. 959.
Van Der Reijden Willy Alexander
Van Nieuw Amerongen Arie
Veerman Engelmundus Cornelis Ignatius
Cintin Marianne M.
Moezie M.
Stichting Voor De Technische Wetenschappen
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